Trial Outcomes & Findings for Psilocybin-facilitated Treatment for Cocaine Use (NCT NCT02037126)
NCT ID: NCT02037126
Last Updated: 2026-05-18
Results Overview
Percentage of days abstinent from cocaine among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview and with biochemically verified cocaine presence as assessed via a urine drug screen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.
Results posted on
2026-05-18
Participant Flow
Recruited at the University of Alabama at Birmingham, May 2015-August 2023, via community outreach.
Participants were screened for inclusion/exclusion criteria and provided psychotherapy prior to randomization.
Participant milestones
| Measure |
Psilocybin Administration
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Randomization
STARTED
|
20
|
20
|
|
Randomization
COMPLETED
|
20
|
20
|
|
Randomization
NOT COMPLETED
|
0
|
0
|
|
Integration Psychotherapy
STARTED
|
20
|
20
|
|
Integration Psychotherapy
COMPLETED
|
20
|
15
|
|
Integration Psychotherapy
NOT COMPLETED
|
0
|
5
|
|
Day 90 Follow-Up Assessment
STARTED
|
20
|
20
|
|
Day 90 Follow-Up Assessment
COMPLETED
|
20
|
18
|
|
Day 90 Follow-Up Assessment
NOT COMPLETED
|
0
|
2
|
|
Day 180 Follow-up Assessment
STARTED
|
20
|
20
|
|
Day 180 Follow-up Assessment
COMPLETED
|
19
|
17
|
|
Day 180 Follow-up Assessment
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psilocybin-facilitated Treatment for Cocaine Use
Baseline characteristics by cohort
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=11 Participants
|
52 years
n=9 Participants
|
50 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
7 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=11 Participants
|
19 Participants
n=9 Participants
|
33 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=11 Participants
|
17 Participants
n=9 Participants
|
33 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=11 Participants
|
3 Participants
n=9 Participants
|
7 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Age at First Cocaine Use
|
22 years
n=11 Participants
|
22 years
n=9 Participants
|
22 years
n=20 Participants
|
PRIMARY outcome
Timeframe: From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.Percentage of days abstinent from cocaine among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview and with biochemically verified cocaine presence as assessed via a urine drug screen.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Percentage of Abstinent Days
Drug administration to end-of-treatment
|
97.43 Percentage of abstinent days
Standard Error 1.01
|
71.63 Percentage of abstinent days
Standard Error 5.25
|
|
Percentage of Abstinent Days
End-of-treatment to 12 weeks after end-of-treatment
|
98.11 Percentage of abstinent days
Standard Error 0.83
|
61.85 Percentage of abstinent days
Standard Error 7.43
|
|
Percentage of Abstinent Days
12 weeks after end-of-treatment to 24 weeks after end-of-treatment.
|
95.79 Percentage of abstinent days
Standard Error 2.61
|
67.06 Percentage of abstinent days
Standard Error 6.71
|
PRIMARY outcome
Timeframe: From the psilocybin or placebo administration session to 24 weeks after end-of-treatment.Complete abstinence from cocaine among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview and with biochemically verified cocaine presence as assessed via a urine drug screen.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Number of Participants With Complete Abstinence From Cocaine
|
6 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the psilocybin or placebo administration session to 24 weeks after end-of-treatment.Population: One participant in the placebo group was lost to follow-up after drug administration, and therefore only 19 of 20 participants in this group provided data for this outcome variable.
Number of days to first use of cocaine after the drug administration session among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview and with biochemically verified cocaine presence as assessed via a urine drug screen.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=19 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Number of Days to First Use of Cocaine
|
74.6 Number of days to first use of cocaine
Standard Error 18.6
|
25.7 Number of days to first use of cocaine
Standard Error 12.2
|
SECONDARY outcome
Timeframe: Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.Ratings on the Severity of Dependence Scale (SDS) among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed via self-report. Severity of Dependence Scale (SDS) ratings are the sum of the five item values and range from 0 (indicating no dependence symptoms on the scale) to 15 (indicating the highest level of dependence).
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Severity of Dependence Scale
Within 48 hours after psilocybin or placebo administration
|
4 Scores on a scale
Standard Error .85
|
6.66 Scores on a scale
Standard Error .54
|
|
Severity of Dependence Scale
At end-of-treatment
|
2.3 Scores on a scale
Standard Error .78
|
5.75 Scores on a scale
Standard Error .65
|
|
Severity of Dependence Scale
At 12 weeks after end-of-treatment
|
1.89 Scores on a scale
Standard Error .69
|
7.0 Scores on a scale
Standard Error .54
|
|
Severity of Dependence Scale
At 24 weeks after end-of-treatment
|
2.02 Scores on a scale
Standard Error .77
|
7.8 Scores on a scale
Standard Error .71
|
SECONDARY outcome
Timeframe: Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.Ratings on the Cocaine Selective Severity Assessment (CSSA) among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo). Ratings range from 0 to 112, reflecting the sum of the individual items. Higher scores indicate greater withdrawal severity.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Cocaine Selective Severity Assessment
Within 48 hours after psilocybin or placebo administration
|
10.0 Scores on a scale
Standard Error 2.07
|
12.89 Scores on a scale
Standard Error 2.6
|
|
Cocaine Selective Severity Assessment
At end-of-treatment
|
10.65 Scores on a scale
Standard Error 2.1
|
10.93 Scores on a scale
Standard Error 3.03
|
|
Cocaine Selective Severity Assessment
At 12 weeks after end-of-treatment
|
9.31 Scores on a scale
Standard Error 2.87
|
19.88 Scores on a scale
Standard Error 3.55
|
|
Cocaine Selective Severity Assessment
At 24 weeks after end-of-treatment
|
8.7 Scores on a scale
Standard Error 1.85
|
22.64 Scores on a scale
Standard Error 4.42
|
SECONDARY outcome
Timeframe: Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.Ratings on the Cocaine Craving Questionnaire-Brief (CCQ-B) among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed via self-report. The Cocaine Craving Questionnaire-Brief (CCQ-B) is a 10-item scale, and mean scores are reported (possible range = 0 to 7), with greater scores representing more craving.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Cocaine Craving Questionnaire
At end-of-treatment
|
1.21 Scores on a scale
Standard Error .12
|
1.3 Scores on a scale
Standard Error .1
|
|
Cocaine Craving Questionnaire
Within 48 hours after psilocybin or placebo administration
|
1.1 Scores on a scale
Standard Error .06
|
1.57 Scores on a scale
Standard Error .16
|
|
Cocaine Craving Questionnaire
At 12 weeks after end-of-treatment
|
1.28 Scores on a scale
Standard Error .17
|
1.76 Scores on a scale
Standard Error .22
|
|
Cocaine Craving Questionnaire
At 24 weeks after end-of-treatment
|
1.24 Scores on a scale
Standard Error .14
|
1.94 Scores on a scale
Standard Error .27
|
SECONDARY outcome
Timeframe: Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.Ratings on the Brief Situational Confidence Questionnaire (BSCQ) among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed via self-report. A global/average score across the 8 items is calculated, ranging 0-100. Higher scores indicate greater confidence to resist the urge to use cocaine.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Situational Confidence Questionnaire
At 24 weeks after end-of-treatment
|
79.7 Scores on a scale
Standard Error 5.5
|
66 Scores on a scale
Standard Error 5.2
|
|
Situational Confidence Questionnaire
Within 48 hours after psilocybin or placebo administration
|
80 Scores on a scale
Standard Error 4.1
|
68.2 Scores on a scale
Standard Error 4.9
|
|
Situational Confidence Questionnaire
At end-of-treatment
|
82.1 Scores on a scale
Standard Error 4.2
|
72.8 Scores on a scale
Standard Error 5.6
|
|
Situational Confidence Questionnaire
At 12 weeks after end-of-treatment
|
79.6 Scores on a scale
Standard Error 4.38
|
60.5 Scores on a scale
Standard Error 4.53
|
SECONDARY outcome
Timeframe: Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.Ratings on the Thoughts About Abstinence Questionnaire among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed via self-report. The Thoughts About Abstinence Questionnaire captures motivation to quit, confidence in the ability to quit, and perceived difficulty quitting with one item each using a 1 to 10 scale. Greater scores represent greater motivation to quit, confidence in the ability to quit, and perceived difficulty quitting, respectively.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Thoughts About Abstinence Questionnaire
Perceived difficulty quitting: 48 hours after psilocybin or placebo administration
|
4.35 Scores on a scale
Standard Error .75
|
4.66 Scores on a scale
Standard Error .67
|
|
Thoughts About Abstinence Questionnaire
Motivation to quit: 48 hours after psilocybin or placebo administration
|
9.9 Scores on a scale
Standard Error .05
|
9.6 Scores on a scale
Standard Error .16
|
|
Thoughts About Abstinence Questionnaire
Motivation to quit: end-of-treatment
|
10 Scores on a scale
Standard Error 0
|
9.6 Scores on a scale
Standard Error .27
|
|
Thoughts About Abstinence Questionnaire
Motivation to quit: 12 weeks after end-of-treatment
|
9.37 Scores on a scale
Standard Error .56
|
9.66 Scores on a scale
Standard Error .18
|
|
Thoughts About Abstinence Questionnaire
Motivation to quit: 24 weeks after end-of-treatment
|
10 Scores on a scale
Standard Error 0
|
9.5 Scores on a scale
Standard Error .33
|
|
Thoughts About Abstinence Questionnaire
Confidence in ability to quit: 48 hours after psilocybin or placebo administration
|
9.65 Scores on a scale
Standard Error .26
|
8.9 Scores on a scale
Standard Error .24
|
|
Thoughts About Abstinence Questionnaire
Confidence in ability to quit: end-of-treatment
|
9.6 Scores on a scale
Standard Error .26
|
8.75 Scores on a scale
Standard Error .44
|
|
Thoughts About Abstinence Questionnaire
Confidence in ability to quit: 12 weeks after end-of-treatment
|
9.68 Scores on a scale
Standard Error .18
|
8.16 Scores on a scale
Standard Error .46
|
|
Thoughts About Abstinence Questionnaire
Confidence in ability to quit: 24 weeks after end-of-treatment
|
9.63 Scores on a scale
Standard Error .17
|
8.64 Scores on a scale
Standard Error .35
|
|
Thoughts About Abstinence Questionnaire
Perceived difficulty quitting: end-of-treatment
|
3.9 Scores on a scale
Standard Error .86
|
5.68 Scores on a scale
Standard Error .84
|
|
Thoughts About Abstinence Questionnaire
Perceived difficulty quitting: 12 weeks after end-of-treatment
|
3.42 Scores on a scale
Standard Error .75
|
6.27 Scores on a scale
Standard Error .73
|
|
Thoughts About Abstinence Questionnaire
Perceived difficulty quitting: 24 weeks after end-of-treatment
|
3.89 Scores on a scale
Standard Error .86
|
6.17 Scores on a scale
Standard Error .81
|
SECONDARY outcome
Timeframe: Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.Ratings on the Depression, Anxiety, and Stress Scale (DASS-21) among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed via self-report. This questionnaire provides mean scores for depression, anxiety, and stress, with total possible scores ranging from 0 to 3. Greater scores represent more depression, anxiety, and stress, respectively.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Depression, Anxiety, and Stress Scale
Anxiety: Within 48 hours after psilocybin or placebo administration
|
.42 Scores on a scale
Standard Error .14
|
.61 Scores on a scale
Standard Error .14
|
|
Depression, Anxiety, and Stress Scale
Anxiety: end-of-treatment
|
.38 Scores on a scale
Standard Error .13
|
.65 Scores on a scale
Standard Error .16
|
|
Depression, Anxiety, and Stress Scale
Stress: 24 weeks after end-of-treatment
|
.61 Scores on a scale
Standard Error .18
|
.74 Scores on a scale
Standard Error .14
|
|
Depression, Anxiety, and Stress Scale
Depression: Within 48 hours after psilocybin or placebo administration
|
.38 Scores on a scale
Standard Error .15
|
.62 Scores on a scale
Standard Error .14
|
|
Depression, Anxiety, and Stress Scale
Depression: end-of-treatment
|
.33 Scores on a scale
Standard Error .13
|
.58 Scores on a scale
Standard Error .14
|
|
Depression, Anxiety, and Stress Scale
Depression: 12 weeks after end-of-treatment
|
.41 Scores on a scale
Standard Error .17
|
.57 Scores on a scale
Standard Error .15
|
|
Depression, Anxiety, and Stress Scale
Depression: 24 weeks after end-of-treatment
|
.37 Scores on a scale
Standard Error .15
|
.64 Scores on a scale
Standard Error .19
|
|
Depression, Anxiety, and Stress Scale
Anxiety: 12 weeks after end-of-treatment
|
.53 Scores on a scale
Standard Error .19
|
.51 Scores on a scale
Standard Error .10
|
|
Depression, Anxiety, and Stress Scale
Anxiety: 24 weeks after end-of-treatment
|
.47 Scores on a scale
Standard Error .16
|
.66 Scores on a scale
Standard Error .16
|
|
Depression, Anxiety, and Stress Scale
Stress: Within 48 hours after psilocybin or placebo administration
|
.48 Scores on a scale
Standard Error .11
|
.81 Scores on a scale
Standard Error .17
|
|
Depression, Anxiety, and Stress Scale
Stress: end-of-treatment
|
.48 Scores on a scale
Standard Error .13
|
.81 Scores on a scale
Standard Error .16
|
|
Depression, Anxiety, and Stress Scale
Stress: 12 weeks after end-of-treatment
|
.56 Scores on a scale
Standard Error .17
|
.79 Scores on a scale
Standard Error .17
|
SECONDARY outcome
Timeframe: Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.Ratings on the Satisfaction with Life Scale among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed via self-report. A sum of the 5 items yields a total score, ranging from 5 to 35. Greater scores represent more satisfaction with life.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Satisfaction With Life Scale
Satisfaction with Life: 24 weeks after end-of-treatment
|
23 Scores on a scale
Standard Error 1.7
|
16.64 Scores on a scale
Standard Error 1.88
|
|
Satisfaction With Life Scale
Satisfaction with Life: Within 48 hours after psilocybin or placebo administration
|
22.65 Scores on a scale
Standard Error 1.35
|
16.89 Scores on a scale
Standard Error 1.62
|
|
Satisfaction With Life Scale
Satisfaction with Life: end-of-treatment
|
23.75 Scores on a scale
Standard Error 1.49
|
18.75 Scores on a scale
Standard Error 1.84
|
|
Satisfaction With Life Scale
Satisfaction with Life: 12 weeks after end-of-treatment
|
23.89 Scores on a scale
Standard Error 1.51
|
16.6 Scores on a scale
Standard Error 1.83
|
SECONDARY outcome
Timeframe: At 24 weeks after end-of-treatment.Population: Data are available for those who completed assessment at 24 weeks after end-of-treatment and completed the brief demographic questionnaire; not all participants opted to complete this questionnaire.
Responses on a brief demographic questionnaire among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed via self-report. Income is reported as estimated annual income based on current earnings.
Outcome measures
| Measure |
Psilocybin Administration
n=18 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=15 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Individual Income
$20,000 per year or less
|
7 Participants
|
10 Participants
|
|
Individual Income
More than $20,000 per year
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At 24 weeks after end-of-treatment.Population: Data are available for those who completed assessment at 24 weeks after end-of-treatment and completed the brief demographic questionnaire; not all participants opted to complete this questionnaire.
Responses on a brief demographic questionnaire among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed via self-report. Participants reported being unemployed, or not unemployed (employed, retired or on disability, or a student).
Outcome measures
| Measure |
Psilocybin Administration
n=18 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=15 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Employment Status
Unemployed
|
3 Participants
|
6 Participants
|
|
Employment Status
Not unemployed
|
15 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: At 24 weeks after end-of-treatment.Population: Data are available for those who completed assessment at 24 weeks after end-of-treatment and completed the brief demographic questionnaire; not all participants opted to complete this questionnaire.
Responses on a brief demographic questionnaire among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed via self-report. Participants reported having a stable living situation (e.g., living in a house or apartment they owned or rented) an unstable living situation (e.g., experiencing homelessness).
Outcome measures
| Measure |
Psilocybin Administration
n=18 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=15 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Living Situation
Stable living situation
|
16 Participants
|
12 Participants
|
|
Living Situation
Unstable living situation
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.Percentage of days abstinent from alcohol among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Percentage of Alcohol Abstinent Days
From 12 weeks after end-of-treatment to 24 weeks after end-of-treatment
|
7.19 Percentage of alcohol abstinent days
Standard Error 14.06
|
27.39 Percentage of alcohol abstinent days
Standard Error 34.32
|
|
Percentage of Alcohol Abstinent Days
From the psilocybin or placebo administration session to end-of-treatment
|
5.7 Percentage of alcohol abstinent days
Standard Error 11.34
|
27.68 Percentage of alcohol abstinent days
Standard Error 32.10
|
|
Percentage of Alcohol Abstinent Days
From end-of-treatment to 12 weeks after end-of-treatment
|
5.85 Percentage of alcohol abstinent days
Standard Error 7.86
|
34.32 Percentage of alcohol abstinent days
Standard Error 37.3
|
SECONDARY outcome
Timeframe: From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.Percentage of days abstinent from heavy alcohol use among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Percentage of Heavy Alcohol Abstinent Days
From 12 weeks after end-of-treatment to 24 weeks after end-of-treatment
|
4.09 Percentage of days abstinent
Standard Error 13.55
|
16.01 Percentage of days abstinent
Standard Error 28.21
|
|
Percentage of Heavy Alcohol Abstinent Days
From the psilocybin or placebo administration session to end-of-treatment
|
1.8 Percentage of days abstinent
Standard Error 4.88
|
13.29 Percentage of days abstinent
Standard Error 24.53
|
|
Percentage of Heavy Alcohol Abstinent Days
From end-of-treatment to 12 weeks after end-of-treatment
|
2.40 Percentage of days abstinent
Standard Error 6.67
|
19.44 Percentage of days abstinent
Standard Error 31.11
|
SECONDARY outcome
Timeframe: From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.Percentage of days abstinent from tobacco among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Percentage of Tobacco Abstinent Days
From the psilocybin or placebo administration session to end-of-treatment
|
55.07 Percentage of tobacco abstinent days
Standard Error 46.01
|
63.52 Percentage of tobacco abstinent days
Standard Error 40.91
|
|
Percentage of Tobacco Abstinent Days
From end-of-treatment to 12 weeks after end-of-treatment
|
53.80 Percentage of tobacco abstinent days
Standard Error 48.90
|
75.25 Percentage of tobacco abstinent days
Standard Error 38.96
|
|
Percentage of Tobacco Abstinent Days
From 12 weeks after end-of-treatment to 24 weeks after end-of-treatment
|
49.36 Percentage of tobacco abstinent days
Standard Error 48.50
|
74.05 Percentage of tobacco abstinent days
Standard Error 38.46
|
SECONDARY outcome
Timeframe: From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.Percentage of days abstinent from cannabis among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview.
Outcome measures
| Measure |
Psilocybin Administration
n=20 Participants
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 Participants
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Percentage of Cannabis Abstinent Days
From the psilocybin or placebo administration session to end-of-treatment
|
14.31 Percentage of cannabis abstinent days
Standard Error 26.76
|
28.57 Percentage of cannabis abstinent days
Standard Error 39.09
|
|
Percentage of Cannabis Abstinent Days
From end-of-treatment to 12 weeks after end-of-treatment
|
21.99 Percentage of cannabis abstinent days
Standard Error 34.28
|
36.85 Percentage of cannabis abstinent days
Standard Error 43.99
|
|
Percentage of Cannabis Abstinent Days
From 12 weeks after end-of-treatment to 24 weeks after end-of-treatment
|
18.19 Percentage of cannabis abstinent days
Standard Error 33.49
|
31.24 Percentage of cannabis abstinent days
Standard Error 43.57
|
Adverse Events
Psilocybin Administration
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Diphenhydramine Administration
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Psilocybin Administration
n=20 participants at risk
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
|
Diphenhydramine Administration
n=20 participants at risk
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
|
|---|---|---|
|
Cardiac disorders
Hypertension NOS
|
30.0%
6/20 • From drug administration until final follow-up, an average of 7-8 months
|
10.0%
2/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Gastrointestinal disorders
Hunger
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
General disorders
Hot flashes with chills
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Psychiatric disorders
Emotional distress
|
25.0%
5/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Psychiatric disorders
Crying
|
25.0%
5/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Reproductive system and breast disorders
Spontaneous orgasm
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Psychiatric disorders
Suicidal ideation
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Nervous system disorders
Altered perception
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
|
Nervous system disorders
Heightened visual imagery
|
5.0%
1/20 • From drug administration until final follow-up, an average of 7-8 months
|
0.00%
0/20 • From drug administration until final follow-up, an average of 7-8 months
|
Additional Information
Peter S. Hendricks, Ph.D., University Professor and Heersink Endowed Chair of Psychiatry
University of Alabama at Birmingham
Phone: 205.202.1387
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place