Phase 2
N=40
Psilocybin-facilitated Treatment for Cocaine Use
Cocaine-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02037126 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Percentage of Abstinent Days — 97.43; 71.63; 98.11; 61.85 Percentage of abstinent days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Psilocybin (Drug); Diphenhydramine (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Abstinent Days |
97.43; 71.63; 98.11; 61.85; 95.79; 67.06 | — |
| PRIMARY Number of Participants With Complete Abstinence From Cocaine |
6; 0 | — |
| PRIMARY Number of Days to First Use of Cocaine |
74.6; 25.7 | — |
| SECONDARY Severity of Dependence Scale |
4; 6.66; 2.3; 5.75; 1.89; 7.0 | — |
| SECONDARY Cocaine Selective Severity Assessment |
10.0; 12.89; 10.65; 10.93; 9.31; 19.88 | — |
| SECONDARY Cocaine Craving Questionnaire |
1.1; 1.57; 1.21; 1.3; 1.28; 1.76 | — |
| SECONDARY Situational Confidence Questionnaire |
80; 68.2; 82.1; 72.8; 79.6; 60.5 | — |
| SECONDARY Thoughts About Abstinence Questionnaire |
9.9; 9.6; 10; 9.6; 9.37; 9.66 | — |
| SECONDARY Depression, Anxiety, and Stress Scale |
.38; .62; .33; .58; .41; .57 | — |
| SECONDARY Satisfaction With Life Scale |
22.65; 16.89; 23.75; 18.75; 23.89; 16.6 | — |
| SECONDARY Individual Income |
7; 10; 11; 5 | — |
| SECONDARY Employment Status |
3; 6; 15; 9 | — |
| SECONDARY Living Situation |
16; 12; 2; 3 | — |
| SECONDARY Percentage of Alcohol Abstinent Days |
5.7; 27.68; 5.85; 34.32; 7.19; 27.39 | — |
| SECONDARY Percentage of Heavy Alcohol Abstinent Days |
1.8; 13.29; 2.40; 19.44; 4.09; 16.01 | — |
| SECONDARY Percentage of Tobacco Abstinent Days |
55.07; 63.52; 53.80; 75.25; 49.36; 74.05 | — |
| SECONDARY Percentage of Cannabis Abstinent Days |
14.31; 28.57; 21.99; 36.85; 18.19; 31.24 | — |
Summary
The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement.
MRI assessment is a unique aspect of this study. As a potential biological mechanism of psilocybin's effect includes changes in default mode network functional connectivity (Carhart-Harris et al., 2012), we will determine if psilocybin's therapeutic effects are mediated by such changes. Moreover, as Glx (a brain metabolite that reflects glutamate) abnormalities have been shown to play a role in cocaine addiction, we will determine if psilocybin impacts Glx in the anterior cingulate cortex and hippocampus.
Eligibility Criteria
Inclusion Criteria
- 25 years of age and older
- Score of at least 3 on the Severity of Dependence Scale
- Desire to cease cocaine use as indicated by a goal of complete cocaine abstinence on the Thoughts about Abstinence questionnaire
- Ability to read/write in English
- No prior hallucinogen use or it will have been at least 3 years since their last use of a hallucinogen
- Availability of a friend or family member into whose care the participant can be released following their drug administration session.
- In good general health as assessed by detailed medical history and physical examination
- Abstinence from cocaine for at least 7 days prior to experimental drug administration as confirmed via urinalysis and no signs of intoxication on other drugs.
Exclusion Criteria
- 24 years of age and younger
- Women who are pregnant or breast feeding
- Current psychiatric diagnoses other than substance abuse/dependence
- Current hypertension (exceeding 140 systolic and 90 diastolic at resting as described below)
- Use of tricyclic antidepressants, lithium, Selective Serotonin Reuptake Inhibitors, Monoamine Oxidase Inhibitors, haloperidol, St. John's Wort, or other antipsychotic medications, mood stabilizers, or medications with serotonin activity
- History of any psychotic disorders
- History of bipolar I or II disorder
- First or second-degree relatives with any psychotic disorders, or bipolar I or II disorders
- Current suicidal or homicidal ideation
- Planning to move from the Birmingham area in the next 6 months
- Contraindications of MRI (metallic objects in the body, claustrophobia, difficulty with prior MRI)
Data sourced from ClinicalTrials.gov (NCT02037126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.