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Lysergic Acid Diethylamide (LSD)-Assisted Psychotherapy in People With Illness-related Anxiety

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: NCT00920387
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : December 8, 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: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Anxiety
Interventions Drug: 200 mcg LSD
Drug: 20 mcg LSD
Behavioral: Therapy
Enrollment 12
Recruitment Details Participants were recruited through general information about the study reported in media, by flyers, presentations in hospitals or cancer support groups, or referral from other physicians.
Pre-assignment Details  
Arm/Group Title Full Dose LSD (200 mcg) Blinded Stage 1 Active Placebo LSD (20 mcg) Stage 1 Full Dose LSD (200 mcg) Open-Label Stage 2
Hide Arm/Group Description

200 mcg LSD administered once during each of two blinded LSD-assisted therapy sessions, scheduled two to four weeks apart during Stage 1

200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

20 mcg LSD administered once during each of two blinded LSD-assisted therapy sessions, scheduled two to four weeks apart during Stage 1.

20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

200 mcg LSD administered open-label once during two experimental sessions, scheduled two to eight weeks apart during Stage 2
Period Title: Stage 1
Started 8 4 0
Completed 7 4 0
Not Completed 1 0 0
Reason Not Completed
Adverse Event             1             0             0
Period Title: Stage 2
Started 0 0 3
Completed 0 0 3
Not Completed 0 0 0
Arm/Group Title Full Dose LSD (200 mcg) Active Placebo LSD (20 mcg) Total
Hide Arm/Group Description

200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.

200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.

20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

Total of all reporting groups
Overall Number of Baseline Participants 8 3 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 3 participants 11 participants
49.6  (8.4) 57.4  (9.9) 51.7  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 3 participants 11 participants
Female
3
  37.5%
1
  33.3%
4
  36.4%
Male
5
  62.5%
2
  66.7%
7
  63.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
History of suicidal tendencies  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 3 participants 11 participants
None
8
 100.0%
1
  33.3%
9
  81.8%
Mild
0
   0.0%
2
  66.7%
2
  18.2%
Type of life-threatening illness  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 3 participants 11 participants
Metastatic breast carcinoma
3
  37.5%
1
  33.3%
4
  36.4%
Metastatic gastric carcinoma
2
  25.0%
0
   0.0%
2
  18.2%
Plasmocytoma
1
  12.5%
0
   0.0%
1
   9.1%
Non-Hodgkin's Lymphoma
0
   0.0%
1
  33.3%
1
   9.1%
Celiac Disease
0
   0.0%
1
  33.3%
1
   9.1%
Parkinson's Disease
1
  12.5%
0
   0.0%
1
   9.1%
Bechterew's Disease
1
  12.5%
0
   0.0%
1
   9.1%
1.Primary Outcome
Title Baseline State-Trait Anxiety Inventory (STAI)
Hide Description The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The STAI-state subscale is a 20-item self-reported scale which assesses subjects' levels of transient, situationally oriented, anxiety. Participants respond to each item by selecting a response from a 4-point Likert scale ranging from 4 ("Not at all") to 1 ("Very much so"). STAI-state scores are summed for a total score that range from 20 to 80, with higher scores indicating greater state anxiety. The STAI-trait subscale also consists of 20-items and is scored the same way, with total scores ranging from 20 to 80, with higher scores indicating greater trait anxiety.
Time Frame Baseline (Visit 4)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Dose LSD (200 mcg) Active Placebo LSD (20 mcg)
Hide Arm/Group Description:

200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.

200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.

20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

Overall Number of Participants Analyzed 8 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
STAI-state 53.1  (4.7) 47.7  (7.7)
STAI-trait 53.2  (4.3) 43.3  (7.0)
2.Primary Outcome
Title Primary Endpoint State-Trait Anxiety Inventory (STAI)
Hide Description The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The STAI-state subscale is a 20-item self-reported scale which assesses subjects' levels of transient, situationally oriented, anxiety. Participants respond to each item by selecting a response from a 4-point Likert scale ranging from 4 ("Not at all") to 1 ("Very much so"). STAI-state scores are summed for a total score that range from 20 to 80, with higher scores indicating greater state anxiety. The STAI-trait subscale also consists of 20-items and is scored the same way, with total scores ranging from 20 to 80, with higher scores indicating greater trait anxiety.
Time Frame 2 months after second experimental session
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Dose LSD (200 mcg) Active Placebo LSD (20 mcg)
Hide Arm/Group Description:

200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.

200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.

20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

Overall Number of Participants Analyzed 8 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
STAI-state 41.5  (3.2) 51.7  (5.3)
STAI-trait 45.2  (3.7) 49.0  (6.1)
Time Frame From enrollment to end of Stage 2 (approximately 11 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Full Dose LSD (200 mcg Stage 1) Active Placebo LSD (20 mcg Stage 1) Full Dose LSD (200 mcg Stage 2)
Hide Arm/Group Description

200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.

200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.

20 mcg LSD: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to eight weeks apart.

200 mcg LSD: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session

Therapy: Therapy provided by male and female co-therapists

All-Cause Mortality
Full Dose LSD (200 mcg Stage 1) Active Placebo LSD (20 mcg Stage 1) Full Dose LSD (200 mcg Stage 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   0/4 (0.00%)   0/3 (0.00%) 
Hide Serious Adverse Events
Full Dose LSD (200 mcg Stage 1) Active Placebo LSD (20 mcg Stage 1) Full Dose LSD (200 mcg Stage 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   1/4 (25.00%)   0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastic Esophageal Cancer *  1/8 (12.50%)  0/4 (0.00%)  0/3 (0.00%) 
Renal and urinary disorders       
Pyelonephritis *  0/8 (0.00%)  1/4 (25.00%)  0/3 (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%
Full Dose LSD (200 mcg Stage 1) Active Placebo LSD (20 mcg Stage 1) Full Dose LSD (200 mcg Stage 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   4/4 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders       
Anemia *  1/8 (12.50%)  0/4 (0.00%)  0/3 (0.00%) 
Eye disorders       
Mydriasis *  3/8 (37.50%)  0/4 (0.00%)  0/3 (0.00%) 
General disorders       
Feeling Cold *  6/8 (75.00%)  0/4 (0.00%)  1/3 (33.33%) 
Impaired Gait *  2/8 (25.00%)  0/4 (0.00%)  2/3 (66.67%) 
Feeling of Relaxation *  0/8 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Asthenia *  0/8 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Infections and infestations       
Pneumonia *  1/8 (12.50%)  0/4 (0.00%)  0/3 (0.00%) 
Injury, poisoning and procedural complications       
Femur Fracture *  1/8 (12.50%)  0/4 (0.00%)  0/3 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasm progression *  1/8 (12.50%)  0/4 (0.00%)  0/3 (0.00%) 
Nervous system disorders       
Headache *  1/8 (12.50%)  0/4 (0.00%)  0/3 (0.00%) 
Disturbance in Attention *  0/8 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Psychiatric disorders       
Anxiety *  2/8 (25.00%)  2/4 (50.00%)  1/3 (33.33%) 
Anger *  1/8 (12.50%)  2/4 (50.00%)  0/3 (0.00%) 
Affect Liability *  1/8 (12.50%)  1/4 (25.00%)  1/3 (33.33%) 
Emotional Distress *  5/8 (62.50%)  1/4 (25.00%)  0/3 (0.00%) 
Time Perception Altered *  4/8 (50.00%)  0/4 (0.00%)  2/3 (66.67%) 
Thinking Abnormal *  1/8 (12.50%)  1/4 (25.00%)  0/3 (0.00%) 
Perseveration *  0/8 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Tachyphrenia *  0/8 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Feeling Abnormal *  5/8 (62.50%)  2/4 (50.00%)  1/3 (33.33%) 
Derealization *  1/8 (12.50%)  0/4 (0.00%)  1/3 (33.33%) 
Bradyphrenia *  1/8 (12.50%)  0/4 (0.00%)  0/3 (0.00%) 
Hallucination *  1/8 (12.50%)  0/4 (0.00%)  0/3 (0.00%) 
Illusions *  6/8 (75.00%)  1/4 (25.00%)  2/3 (66.67%) 
Depersonalization *  0/8 (0.00%)  0/4 (0.00%)  1/3 (33.33%) 
Altered Perception of Music *  0/8 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Reproductive system and breast disorders       
Menorrhagia *  1/8 (12.50%)  0/4 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders       
Palmar-plantar Erythrody Saesthesia Syndrome *  1/8 (12.50%)  0/4 (0.00%)  0/3 (0.00%) 
Skin Lesion *  0/8 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
Perspiration *  2/8 (25.00%)  0/4 (0.00%)  0/3 (0.00%) 
Pruritus *  0/8 (0.00%)  1/4 (25.00%)  0/3 (0.00%) 
*
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 Corp.
Phone: (831) 429-6362
EMail: juliewang@mapsbcorp.com
Layout table for additonal information
Responsible Party: Multidisciplinary Association for Psychedelic Studies
ClinicalTrials.gov Identifier: NCT00920387    
Other Study ID Numbers: LDA1
First Submitted: June 12, 2009
First Posted: June 15, 2009
Results First Submitted: November 9, 2021
Results First Posted: December 8, 2021
Last Update Posted: July 6, 2022