Skip to content
CompletedPhase 2Results posted

Psilocybin-facilitated Treatment for Cocaine Use

NCT02037126 · University of Alabama at Birmingham

Closed to entry
Status
Not accepting participants
Phase 2
Phase
40
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Percentage of Abstinent Days

    Measured over 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.

  • Number of Participants With Complete Abstinence From Cocaine

    Measured over From the psilocybin or placebo administration session to 24 weeks after end-of-treatment.

  • Number of Days to First Use of Cocaine

    Measured over From the psilocybin or placebo administration session to 24 weeks after end-of-treatment.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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)

Where

1 study site

FacilityCityRegionCountry
UAB Outpatient Clinical Research UnitBirminghamAlabamaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02037126 on ClinicalTrials.gov →

Last updated in the registry 2026-05-18. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits