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NCT02037126 · ClinicalTrials.gov registry record · Phase 2
Psilocybin-facilitated Treatment for Cocaine Use
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02037126: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT02037126 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02037126, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Psilocybin
- DRUG Diphenhydramine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-05 |
| Est. Completion | 2024-05 |
| Phase | Phase 2 |
What the finished NCT02037126 record still lists
NCT02037126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Psilocybin is the first listed.
NCT02037126 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02037126 about?
NCT02037126 is a clinical study titled "Psilocybin-facilitated Treatment for Cocaine Use". 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 ...
What is the current status of trial NCT02037126?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2015-05. Estimated completion is 2024-05.
What interventions are being tested in trial NCT02037126?
The interventions under investigation include: Psilocybin (DRUG), Diphenhydramine (DRUG).
Who is sponsoring clinical trial NCT02037126?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02037126's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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