Psilocybin-facilitated Treatment for Cocaine Use (NCT02037126) | Clinical Trial Compass
CompletedPhase 2
Psilocybin-facilitated Treatment for Cocaine Use
United States40 participantsStarted 2015-05
Plain-language 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.
Who can participate
Age range
25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Abstinent Days
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.
2
Number of Participants With Complete Abstinence From Cocaine
Timeframe: From the psilocybin or placebo administration session to 24 weeks after end-of-treatment.
3
Number of Days to First Use of Cocaine
Timeframe: From the psilocybin or placebo administration session to 24 weeks after end-of-treatment.