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Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02759185
Recruitment Status : Completed
First Posted : May 3, 2016
Results First Posted : September 16, 2021
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Posttraumatic Stress Disorder
Interventions Drug: High THC cannabis
Drug: High CBD cannabis
Drug: THC/CBD cannabis
Drug: Placebo cannabis
Enrollment 80
Recruitment Details Participants were recruited via letters of referral sent to psychiatrists and psychotherapists, contact with veterans' organizations, advertisements or announcements placed in appropriate locations or on appropriate internet sites and the sponsor site, and word of mouth.
Pre-assignment Details For Stage 2, participants were re-randomized into one of three treatment groups which excluded placebo and their Stage 1 treatment assignment.
Arm/Group Title High THC Cannabis (Stage 1) High CBD Cannabis (Stage 1) THC/CBD Cannabis (Stage 1) Placebo Cannabis (Stage 1) High THC Cannabis (Stage 2) High CBD Cannabis (Stage 2) THC/CBD Cannabis (Stage 2)
Hide Arm/Group Description

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Period Title: Stage 1
Started 20 20 20 20 0 0 0
Completed 19 19 17 20 0 0 0
Not Completed 1 1 3 0 0 0 0
Reason Not Completed
Adverse Event             0             1             3             0             0             0             0
Withdrawal by Subject             1             0             0             0             0             0             0
Period Title: Stage 2
Started 0 0 0 0 29 27 18
Completed 0 0 0 0 27 24 17
Not Completed 0 0 0 0 2 3 1
Reason Not Completed
Adverse Event             0             0             0             0             1             2             0
Withdrawal by Subject             0             0             0             0             1             1             1
Arm/Group Title High THC Cannabis High CBD Cannabis High THC/ High CBD Cannabis Placebo Cannabis Total
Hide Arm/Group Description

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: Three weeks of smoking cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day of marijuana with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: Three weeks of smoking cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

High THC/high CBD cannabis: Three weeks of smoking cannabis containing equal amounts of THC and CBD, with smoking limited to no more than 1.8 g per day.

Provided 1.8 g of cannabis per day a with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: Three weeks of smoking cannabis with low levels of THC and CBD, with smoking limited to no more than 1.8 per day.

Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 20 80
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
45.0  (16.6) 40.4  (11.2) 50.6  (13.3) 43.7  (12.5) 44.9  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
Female
1
   5.0%
2
  10.0%
3
  15.0%
2
  10.0%
8
  10.0%
Male
19
  95.0%
18
  90.0%
17
  85.0%
18
  90.0%
72
  90.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
Non-Hispanic White
11
  55.0%
14
  70.0%
14
  70.0%
14
  70.0%
53
  66.3%
Other
9
  45.0%
6
  30.0%
6
  30.0%
6
  30.0%
27
  33.8%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
High School Graduate
0
   0.0%
3
  15.0%
1
   5.0%
2
  10.0%
6
   7.5%
Some College/Associate's Degree
13
  65.0%
10
  50.0%
8
  40.0%
11
  55.0%
42
  52.5%
College Graduate
7
  35.0%
7
  35.0%
11
  55.0%
7
  35.0%
32
  40.0%
Body mass index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
32.0  (8.9) 31.3  (6.6) 31.4  (7.4) 33.1  (7.0) 31.9  (7.4)
Combat-related trauma (yes)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
13
  65.0%
13
  65.0%
15
  75.0%
13
  65.0%
54
  67.5%
Sleep Apnea (STOP-bang)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
Low risk = 1
6
  30.0%
6
  30.0%
4
  20.0%
6
  30.0%
22
  27.5%
Intermediate risk = 2
3
  15.0%
3
  15.0%
3
  15.0%
3
  15.0%
12
  15.0%
High risk = 3
11
  55.0%
11
  55.0%
13
  65.0%
11
  55.0%
46
  57.5%
Cannabis Use Disorders Identification Test-Revised (CUDIT-R)   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
3.9  (3.0) 2.5  (2.8) 2.4  (2.8) 1.7  (2.6) 2.6  (2.8)
[1]
Measure Description: The CUDIT-R is a brief cannabis screening tool to identify cannabis misuse. Participants who report past six month cannabis use are asked eight additional questions on cannabis where each item score range from 0 to 4. The total CUDIT-R score ranges from 0 to 24 with ≥ 8 indicating hazardous cannabis use and ≥ 12 indicating a possible cannabis use disorder.
1.Primary Outcome
Title Baseline CAPS-5 Total Severity Score
Hide Description The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance), and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Time Frame Baseline (3 weeks after randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) set
Arm/Group Title High THC Cannabis High CBD Cannabis THC/CBD Cannabis Placebo Cannabis
Hide Arm/Group Description:

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.

Overall Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
36.6  (7.20) 36.8  (8.23) 38.0  (7.8) 37.3  (6.38)
2.Primary Outcome
Title Stage 1 Primary Endpoint CAPS-5 Total Severity Scores (Visit 5)
Hide Description The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Time Frame Visit 5 (between end of week 3 and start of week 4) of Stage 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) set
Arm/Group Title High THC Cannabis High CBD Cannabis THC/CBD Cannabis Placebo Cannabis
Hide Arm/Group Description:

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

High THC/high CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.

Overall Number of Participants Analyzed 19 19 19 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
20.5  (8.97) 28.1  (13.26) 29.6  (12.17) 24.2  (12.79)
3.Primary Outcome
Title Change in CAPS-5 Total Severity Scores From Baseline to Stage 1 Primary Endpoint (Visit 5)
Hide Description The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Time Frame Baseline (3 weeks after randomization) to Primary Endpoint (Visit 5, between end of week 3 and start of week 4)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) set
Arm/Group Title High THC Cannabis High CBD Cannabis THC/CBD Cannabis Placebo Cannabis
Hide Arm/Group Description:

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.

Overall Number of Participants Analyzed 19 19 19 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
-15.2  (11.03) -8.4  (10.09) -8.5  (9.88) -13.1  (12.10)
4.Secondary Outcome
Title Change in PTSD Checklist (PCL-5) From Baseline to Stage 1 Primary Endpoint
Hide Description The PTSD Checklist (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms. Participants indicate how much distress they have experienced due to various PTSD symptoms on a five-point Likert-type scale (0=not at all, 4=extremely). The total PCL-5 score (a sum of all 20 items) ranges from 0 to 80, with higher scores indicating greater symptom severity.
Time Frame Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Set
Arm/Group Title High THC Cannabis High CBD Cannabis THC/CBD Cannabis Placebo Cannabis
Hide Arm/Group Description:

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.

Overall Number of Participants Analyzed 19 19 18 19
Mean (Standard Deviation)
Unit of Measure: score on a scale
-23.5  (16.5) -12.1  (16.2) -16.4  (9.1) -14.6  (15.6)
5.Secondary Outcome
Title Change in Inventory of Depression and Anxiety (IDAS) Social Anxiety Total Scores From Baseline to Stage 1 Primary Endpoint
Hide Description The Inventory of Depression and Anxiety (IDAS) is a 64-item self-report measure of non-overlapping scales that assess specific depression and anxiety symptoms. Respondents indicate on a scale of 1 (not at all) to 5 (extremely) how much they have felt or experienced several symptoms in the past two weeks. The IDAS consists of 10 symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions. Items that assess social anxiety are summed and range from 5 to 25 with higher scores indicating greater anxiety symptoms.
Time Frame Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) set
Arm/Group Title High THC Cannabis High CBD Cannabis THC/CBD Cannabis Placebo Cannabis
Hide Arm/Group Description:

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.

Overall Number of Participants Analyzed 19 19 18 19
Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.7  (4.2) -2.7  (2.7) -2.2  (2.0) -2.4  (4.3)
6.Secondary Outcome
Title Change in Inventory of Psychosocial Functioning (IPF) From Baseline to Stage 1 Primary Endpoint
Hide Description The Inventory of Psychosocial Functioning (IPF) is an 80-item measure that was developed for use among individuals with PTSD. It assesses current psychosocial functioning across seven domains: romantic relationships, family, work, friendships, parenting, education, and self-care. Items are scored on a 0 (never) to 6 (always) scale. Summation of scores across domains yields a total score for psychosocial functioning, with higher scores indicating greater functional impairment.
Time Frame Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Set
Arm/Group Title High THC Cannabis High CBD Cannabis THC/CBD Cannabis Placebo Cannabis
Hide Arm/Group Description:

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: three weeks of smoking cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.

Overall Number of Participants Analyzed 19 19 18 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.2  (11.9) -1.2  (5.5) 4.1  (8.5) -0.2  (6.7)
7.Secondary Outcome
Title Change in Inventory of Depression and Anxiety (IDAS) General Depression Total Scores From Baseline to Stage 1 Primary Endpoint
Hide Description The Inventory of Depression and Anxiety (IDAS) is a 64-item self-report measure of non-overlapping scales that assess specific depression and anxiety symptoms. Respondents indicate on a scale of 1 (not at all) to 5 (extremely) how much they have felt or experienced several symptoms in the past two weeks. The IDAS consists of 10 symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions. Items that assess general depression are summed and range from 20 to 100 with higher scores indicating greater depressive symptoms.
Time Frame Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Set
Arm/Group Title High THC Cannabis High CBD Cannabis THC/CBD Cannabis Placebo Cannabis
Hide Arm/Group Description:

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.

Overall Number of Participants Analyzed 19 19 18 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
-16.1  (12.6) -11.4  (11.7) -13.4  (9.1) -8.3  (11.2)
8.Secondary Outcome
Title Change in Insomnia Severity Index (ISI) Scores From Baseline to Stage 1 Primary Endpoint
Hide Description The Insomnia Severity Index (ISI) is a brief self-reported measure of insomnia. It consists of seven questions, with responses made on a five-point Likert scale. Three items address difficulty at sleep onset, maintaining sleep, and early waking, and four questions address perceived quality of sleep and effects of sleep difficulties on daily function. Questions are summed into a total score that ranges from 0 to 28 and can be interpreted as ranging from no signs of insomnia to severe insomnia. Higher scores indicate more severe insomnia.
Time Frame Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Set
Arm/Group Title High THC Cannabis High CBD Cannabis THC/CBD Cannabis Placebo Cannabis
Hide Arm/Group Description:

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day where product has more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.

Overall Number of Participants Analyzed 18 19 18 20
Mean (Standard Deviation)
Unit of Measure: score on a scale
-8.8  (5.2) -5.9  (6.5) -6.6  (5.2) -6.1  (5.7)
9.Other Pre-specified Outcome
Title Actigraph Change in Sleep Efficiency
Hide Description Daily sleep measures were collected using the Actigraph Watch at baseline and throughout the study period. Data were processed using the Actigraph Software according to the User Manual to measure "sleep efficiency," which is defined as the proportion of the estimated sleep periods spent asleep. Change in sleep efficiency was calculated and compared across the four treatment groups to assess whether there was any improvement or worsening in sleep efficiency before and after the 4-week treatment period. Other measures included number of days data were collected and average duration in minutes of time that were excluded and not recorded. Daily data were aggregated to analyze participants' average weekly sleep patterns.
Time Frame Change in sleep efficiency from baseline to end of 4-week treatment period (visit 6)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were asked to wear the Actiwatch for sleep measures and all available data were analyzed to assess sleep efficiency. Note: the proportion of missing data prevented robust analysis and interpretation.
Arm/Group Title High CBD Cannabis High THC Cannabis THC/CBD Cannabis Placebo Cannabis
Hide Arm/Group Description:

Provided up to 1.8 g of cannabis per day of marijuana with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: Three weeks of smoking cannabis containing more CBD than THC with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: Three weeks of smoking cannabis containing more THC than CBD with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: Three weeks of smoking cannabis containing equal amounts of THC and CBD with smoking limited to no more than 1.8 g per day.

Provided 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: Three weeks of smoking cannabis with low levels of THC and CBD with smoking limited to no more than 1.8 per day.

Overall Number of Participants Analyzed 13 12 10 12
Mean (Standard Deviation)
Unit of Measure: percentage of total sleep time
0.17  (10.9) 6.83  (6.55) 1.80  (8.39) -0.28  (6.36)
Time Frame Baseline to end of study (Approximately 8 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High THC Cannabis (Stage 1) High CBD Cannabis (Stage 1) THC/CBD Cannabis (Stage 1) Placebo Cannabis (Stage 1) High THC Cannabis (Stage 2) High CBD Cannabis (Stage 2) THC/CBD Cannabis (Stage 2)
Hide Arm/Group Description

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day.

Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol

Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day.

Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol

High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol

High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol

THC/CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day.

All-Cause Mortality
High THC Cannabis (Stage 1) High CBD Cannabis (Stage 1) THC/CBD Cannabis (Stage 1) Placebo Cannabis (Stage 1) High THC Cannabis (Stage 2) High CBD Cannabis (Stage 2) THC/CBD Cannabis (Stage 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/20 (0.00%)   0/29 (0.00%)   0/27 (0.00%)   0/18 (0.00%) 
Hide Serious Adverse Events
High THC Cannabis (Stage 1) High CBD Cannabis (Stage 1) THC/CBD Cannabis (Stage 1) Placebo Cannabis (Stage 1) High THC Cannabis (Stage 2) High CBD Cannabis (Stage 2) THC/CBD Cannabis (Stage 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   3/20 (15.00%)   0/20 (0.00%)   1/29 (3.45%)   1/27 (3.70%)   0/18 (0.00%) 
Cardiac disorders               
Heart palpitations *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/29 (3.45%)  0/27 (0.00%)  0/18 (0.00%) 
Infections and infestations               
Abscess *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  1/27 (3.70%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Pulmonary embolism *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/29 (3.45%)  0/27 (0.00%)  0/18 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High THC Cannabis (Stage 1) High CBD Cannabis (Stage 1) THC/CBD Cannabis (Stage 1) Placebo Cannabis (Stage 1) High THC Cannabis (Stage 2) High CBD Cannabis (Stage 2) THC/CBD Cannabis (Stage 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/20 (85.00%)   19/20 (95.00%)   19/20 (95.00%)   18/20 (90.00%)   22/29 (75.86%)   22/27 (81.48%)   13/18 (72.22%) 
Endocrine disorders               
Hypothyroidism *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/29 (3.45%)  0/27 (0.00%)  0/18 (0.00%) 
Eye disorders               
Dry eye *  3/20 (15.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/29 (3.45%)  0/27 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders               
Abdominal discomfort *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Constipation *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Diarrhea *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  3/20 (15.00%)  0/29 (0.00%)  1/27 (3.70%)  2/18 (11.11%) 
Dry mouth *  3/20 (15.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  2/29 (6.90%)  0/27 (0.00%)  1/18 (5.56%) 
Nausea *  3/20 (15.00%)  0/20 (0.00%)  5/20 (25.00%)  1/20 (5.00%)  3/29 (10.34%)  0/27 (0.00%)  2/18 (11.11%) 
Proctalgia *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Toothache *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Vomiting *  0/20 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/29 (0.00%)  2/27 (7.41%)  2/18 (11.11%) 
Food poisoning *  2/20 (10.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
General disorders               
Asthenia *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Chest discomfort *  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Fatigue *  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Feeling abnormal *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/29 (3.45%)  2/27 (7.41%)  1/18 (5.56%) 
Malaise *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Cellulitis *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Influenza *  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Discomfort *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/29 (3.45%)  0/27 (0.00%)  1/18 (5.56%) 
Infections and infestations               
Ear infection *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Upper respiratory tract infection *  2/20 (10.00%)  2/20 (10.00%)  1/20 (5.00%)  2/20 (10.00%)  5/29 (17.24%)  3/27 (11.11%)  0/18 (0.00%) 
Bronchitis *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Bacterial infection *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  1/27 (3.70%)  0/18 (0.00%) 
Pneumonia *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Streptococcal infection *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Bacterial vaginosis *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Fungal infections *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications               
Fall *  2/20 (10.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Foot fracture *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Heat exhaustion *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  2/18 (11.11%) 
Procedural pain *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Joint dislocation *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Investigations               
Weight decreased *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Weight increased *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Metabolism and nutrition disorders               
Increased appetite *  0/20 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  2/29 (6.90%)  1/27 (3.70%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthritis *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Back pain *  3/20 (15.00%)  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  2/29 (6.90%)  2/27 (7.41%)  3/18 (16.67%) 
Muscle tightness *  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Myalgia *  0/20 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  2/18 (11.11%) 
Neck pain *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  1/27 (3.70%)  1/18 (5.56%) 
Pain in extremity *  0/20 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  1/27 (3.70%)  0/18 (0.00%) 
Torticollis *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Muscle spasms *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  2/29 (6.90%)  0/27 (0.00%)  1/18 (5.56%) 
Musculoskeletal pain *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  2/27 (7.41%)  2/18 (11.11%) 
Nervous system disorders               
Balance disorder *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/29 (3.45%)  0/27 (0.00%)  0/18 (0.00%) 
Disturbance in attention *  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  2/29 (6.90%)  0/27 (0.00%)  0/18 (0.00%) 
Dizziness *  3/20 (15.00%)  1/20 (5.00%)  2/20 (10.00%)  0/20 (0.00%)  2/29 (6.90%)  0/27 (0.00%)  1/18 (5.56%) 
Head discomfort *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Headache *  3/20 (15.00%)  1/20 (5.00%)  4/20 (20.00%)  5/20 (25.00%)  2/29 (6.90%)  1/27 (3.70%)  2/18 (11.11%) 
Hypoaesthesia *  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  2/18 (11.11%) 
Memory impairment *  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Sensory disturbance *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/29 (3.45%)  0/27 (0.00%)  0/18 (0.00%) 
Somnolence *  3/20 (15.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/29 (3.45%)  0/27 (0.00%)  0/18 (0.00%) 
Tremor *  0/20 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Lethargy *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Migraine *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Parosmia *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Syncope *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  2/27 (7.41%)  0/18 (0.00%) 
Psychiatric disorders               
Aggression *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Agitation *  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Anxiety *  5/20 (25.00%)  2/20 (10.00%)  2/20 (10.00%)  3/20 (15.00%)  6/29 (20.69%)  4/27 (14.81%)  1/18 (5.56%) 
Depression *  0/20 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  1/20 (5.00%)  1/29 (3.45%)  1/27 (3.70%)  0/18 (0.00%) 
Emotional distress *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  1/27 (3.70%)  0/18 (0.00%) 
Insomnia *  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  2/29 (6.90%)  2/27 (7.41%)  1/18 (5.56%) 
Irritability *  3/20 (15.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/29 (3.45%)  3/27 (11.11%)  3/18 (16.67%) 
Libido increased *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/29 (0.00%)  1/27 (3.70%)  0/18 (0.00%) 
Nightmare *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  1/29 (3.45%)  0/27 (0.00%)  0/18 (0.00%) 
Panic attack *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/29 (3.45%)  0/27 (0.00%)  1/18 (5.56%) 
Paranoia *  3/20 (15.00%)  0/20 (0.00%)  3/20 (15.00%)  0/20 (0.00%)  3/29 (10.34%)  1/27 (3.70%)  0/18 (0.00%) 
Restlessness *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  1/29 (3.45%)  0/27 (0.00%)  0/18 (0.00%) 
Anger *  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Confusional state *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Hostility *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
Obsessive thoughts *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Suicide ideation *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  2/29 (6.90%)  1/27 (3.70%)  1/18 (5.56%) 
Renal and urinary disorders               
Pollakiuria *  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  1/27 (3.70%)  0/18 (0.00%) 
Urine abnormality *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough *  3/20 (15.00%)  5/20 (25.00%)  2/20 (10.00%)  2/20 (10.00%)  2/29 (6.90%)  2/27 (7.41%)  4/18 (22.22%) 
Nasal congestion *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  1/29 (3.45%)  0/27 (0.00%)  0/18 (0.00%) 
Sinus congestion *  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Throat irritation *  2/20 (10.00%)  4/20 (20.00%)  2/20 (10.00%)  6/20 (30.00%)  2/29 (6.90%)  1/27 (3.70%)  2/18 (11.11%) 
Upper respiratory tract congestion *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Skin irritation *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Dyspnoea *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  1/29 (3.45%)  1/27 (3.70%)  0/18 (0.00%) 
Oropharyngeal pain *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  2/27 (7.41%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders               
Hyperhidrosis *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  2/27 (7.41%)  0/18 (0.00%) 
Surgical and medical procedures               
Surgery *  0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Tooth repair *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  0/18 (0.00%) 
Wisdom teeth removal *  0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/29 (0.00%)  0/27 (0.00%)  1/18 (5.56%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julie B. Wang, MPH, PhD (Senior Clinical Data Scientist)
Organization: Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation
Phone: (831) 429-6362
EMail: juliewang@mapsbcorp.com
Layout table for additonal information
Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT02759185    
Other Study ID Numbers: MJP-1
First Submitted: April 29, 2016
First Posted: May 3, 2016
Results First Submitted: July 22, 2021
Results First Posted: September 16, 2021
Last Update Posted: July 6, 2022