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Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea (PACE)

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ClinicalTrials.gov Identifier: NCT01755091
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
Northwestern University
University of Chicago
Hektoen Institute for Medical Research
Information provided by (Responsible Party):
David W. Carley, University of Illinois at Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sleep Apnea, Obstructive
Interventions Drug: Dronabinol
Drug: Placebo (for Dronabinol)
Enrollment 75
Recruitment Details Participants were recruited from physician referrals at two academic medical centers as well as from the community based upon print and radio advertising between January 2013 and May 2016. The first participant was enrolled in February 2013 and the last participant was enrolled in April 2016.
Pre-assignment Details  
Arm/Group Title Sugar Pill 2.5 mg/Day 10 mg/Day
Hide Arm/Group Description

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol

Period Title: Overall Study
Started 26 22 27
Completed 17 19 20
Not Completed 9 3 7
Reason Not Completed
Withdrawal by Subject             6             1             3
Adverse Event             1             1             1
Lost to Follow-up             1             0             1
Physician Decision             1             1             2
Arm/Group Title Sugar Pill 2.5 mg/Day 10 mg/Day Total
Hide Arm/Group Description

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol

Total of all reporting groups
Overall Number of Baseline Participants 26 22 27 75
Hide Baseline Analysis Population Description
Baseline analysis population includes all participants who were randomized to treatment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 22 participants 27 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
22
 100.0%
27
 100.0%
75
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 22 participants 27 participants 75 participants
Female
8
  30.8%
6
  27.3%
9
  33.3%
23
  30.7%
Male
18
  69.2%
16
  72.7%
18
  66.7%
52
  69.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 22 participants 27 participants 75 participants
Hispanic or Latino
4
  15.4%
5
  22.7%
1
   3.7%
10
  13.3%
Not Hispanic or Latino
22
  84.6%
17
  77.3%
25
  92.6%
64
  85.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   3.7%
1
   1.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 22 participants 27 participants 75 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.8%
0
   0.0%
2
   7.4%
3
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   4.5%
0
   0.0%
1
   1.3%
Black or African American
15
  57.7%
5
  22.7%
13
  48.1%
33
  44.0%
White
9
  34.6%
16
  72.7%
12
  44.4%
37
  49.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.8%
0
   0.0%
0
   0.0%
1
   1.3%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 26 participants 22 participants 27 participants 75 participants
33.39  (6.33) 33.19  (5.09) 33.45  (4.85) 33.35  (6.33)
Apnea/Hypopnea Index  
Mean (Standard Deviation)
Unit of measure:  Events/hour
Number Analyzed 26 participants 22 participants 27 participants 75 participants
23.72  (9.47) 27.54  (12.57) 26.04  (11.92) 25.67  (11.29)
Minimum Arterial Oxygen Saturation  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 26 participants 22 participants 27 participants 75 participants
79.58  (9.62) 79.82  (6.83) 79.96  (6.93) 79.79  (7.84)
Sleep Efficiency   [1] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 26 participants 22 participants 27 participants 75 participants
75.51  (12.50) 80.52  (11.11) 82.74  (12.22) 79.58  (12.25)
[1]
Measure Description: Sleep Efficiency is calculated as the total time spent asleep divided by the total amount of time spent in bed, multiplied by 100.
1.Primary Outcome
Title Change in Apnea/Hypopnea Index (AHI)
Hide Description Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment)
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis performed including all participants who completed the full 6-weeks of treatment.
Arm/Group Title Sugar Pill 2.5 mg/Day 10 mg/Day
Hide Arm/Group Description:

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol

Overall Number of Participants Analyzed 17 19 20
Mean (Standard Deviation)
Unit of Measure: events/hour
7.99  (13.16) -1.71  (11.74) -5.21  (9.52)
2.Primary Outcome
Title Change in Epworth Sleepiness Scale (ESS)
Hide Description Change in ESS derived as: ESS (end of treatment) minus ESS (pre-treatment). The ESS scale has a range of 0 to 24, with 0 representing the least degree of sleepiness and 24 the greatest degree of sleepiness. There are no subscales.
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are missing for 2 participants randomized to receive Placebo treatment; due to technical error in not completing this instrument.
Arm/Group Title Sugar Pill 2.5 mg/Day 10 mg/Day
Hide Arm/Group Description:

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol

Overall Number of Participants Analyzed 15 19 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.47  (3.29) -.26  (2.94) -4.00  (5.13)
3.Primary Outcome
Title Change in Sleep Latency: Maintenance of Wakefulness Test (MWT)
Hide Description Change in MWT derived as: MWT (end of treatment) minus MWT (pre-treatment). The Maintenance of Wakefulness Test measures a person's ability to stay awake in a quiet, dark and nonstimulating room for a period of time.
Time Frame Baseline and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill 2.5 mg/Day 10 mg/Day
Hide Arm/Group Description:

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol

Overall Number of Participants Analyzed 17 19 20
Mean (Standard Deviation)
Unit of Measure: minutes
-2.50  (13.09) -3.70  (9.73) 1.40  (11.71)
4.Secondary Outcome
Title Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.
Hide Description The TSQM measures a person's satisfaction with treatment based on a 7-point scale ranging from "Extremely Dissatisfied" to "Extremely Satisfied" in response to the question, "Taking all things into account, how satisfied or dissatisfied are you with this medication?".
Time Frame Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data are missing for one participant randomized to receive Placebo treatment due to technical error in not collecting the instrument.
Arm/Group Title Sugar Pill 2.5 mg/Day 10 mg/Day
Hide Arm/Group Description:

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol

Overall Number of Participants Analyzed 16 19 20
Measure Type: Count of Participants
Unit of Measure: Participants
Extremely Dissatisfied
3
  18.8%
2
  10.5%
1
   5.0%
Very Dissatisfied
1
   6.3%
2
  10.5%
0
   0.0%
Dissatisfied
0
   0.0%
3
  15.8%
0
   0.0%
Somewhat Satisfied
5
  31.3%
6
  31.6%
4
  20.0%
Satisfied
1
   6.3%
4
  21.1%
4
  20.0%
Very Satisfied
5
  31.3%
1
   5.3%
5
  25.0%
Extremely Satisfied
1
   6.3%
1
   5.3%
6
  30.0%
5.Secondary Outcome
Title Adverse Events (AEs)
Hide Description AEs will be evaluated and tracked throughout subject participation (up to 8 weeks)
Time Frame Up to 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill 2.5 mg/Day 10 mg/Day
Hide Arm/Group Description:

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol

Overall Number of Participants Analyzed 26 22 27
Mean (Standard Deviation)
Unit of Measure: Number of adverse events per participant
3.4  (2.9) 2.8  (3.6) 5.8  (4.7)
6.Secondary Outcome
Title Change in Desaturation Time (DT)
Hide Description Change in DT (total minutes with arterial oxygen saturation below 85% during 8-hour polysomnography) derived as: DT (end of treatment) minus DT (pre-treatment)
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill 2.5 mg/Day 10 mg/Day
Hide Arm/Group Description:

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol

Overall Number of Participants Analyzed 17 19 20
Mean (Standard Deviation)
Unit of Measure: minutes
1.21  (3.46) -0.19  (2.78) -0.17  (6.68)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugar Pill 2.5 mg/Day 10 mg/Day
Hide Arm/Group Description

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Placebo (for Dronabinol)

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Dronabinol

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Dronabinol

All-Cause Mortality
Sugar Pill 2.5 mg/Day 10 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Pill 2.5 mg/Day 10 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/26 (3.85%)      1/22 (4.55%)      0/27 (0.00%)    
Gastrointestinal disorders       
Diarrhea  0/26 (0.00%)  0 1/22 (4.55%)  1 0/27 (0.00%)  0
Injury, poisoning and procedural complications       
Cycling injury [1]  1/26 (3.85%)  1 0/22 (0.00%)  0 0/27 (0.00%)  0
[1]
Struck by vehicle while riding a bicycle
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Sugar Pill 2.5 mg/Day 10 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/26 (34.62%)      13/22 (59.09%)      26/27 (96.30%)    
Gastrointestinal disorders       
Diarrhea  1/26 (3.85%)  1 3/22 (13.64%)  3 4/27 (14.81%)  4
Nausea [1]  1/26 (3.85%)  1 5/22 (22.73%)  5 9/27 (33.33%)  9
Dry mouth  0/26 (0.00%)  0 0/22 (0.00%)  0 3/27 (11.11%)  3
Musculoskeletal and connective tissue disorders       
Muscle aches  1/26 (3.85%)  1 2/22 (9.09%)  2 1/27 (3.70%)  1
Nervous system disorders       
Sleepy [2]  0/26 (0.00%)  0 0/22 (0.00%)  0 17/27 (62.96%)  17
Headache  4/26 (15.38%)  4 3/22 (13.64%)  3 13/27 (48.15%)  13
Dizziness [3]  3/26 (11.54%)  3 1/22 (4.55%)  1 7/27 (25.93%)  7
Euphoria [4]  0/26 (0.00%)  0 1/22 (4.55%)  1 2/27 (7.41%)  2
[1]
Nausea or vomiting
[2]
Increased sleepiness, tiredness or drowsiness
[3]
Dizziness or lightheadedness
[4]
Euphoria or feeling "high"
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
Name/Title: David W. Carley, PhD
Organization: University of Illinois at Chicago
Phone: 312-996-3827
Responsible Party: David W. Carley, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01755091     History of Changes
Other Study ID Numbers: UM1HL112856 2011-06400
UM1HL112856 ( U.S. NIH Grant/Contract )
First Submitted: December 18, 2012
First Posted: December 21, 2012
Results First Submitted: October 24, 2017
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017