Psilocybin for Cocaine Use Disorder

Recruiting in Palo Alto (17 mi)

Overseen ByPeter S. Hendricks, Ph.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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 (e.g., criminal 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

This trial is for adults over 25 who want to stop using cocaine, can read/write in English, and are generally healthy. They must have been abstinent from cocaine for at least a week and not used hallucinogens recently or ever. Participants need support from friends/family and community observers.

Inclusion Criteria

I haven't used cocaine or other drugs for at least 7 days.

I am 25 years old or older.

Exclusion Criteria

I have been diagnosed with bipolar I or II disorder.

A close family member has had a psychotic or bipolar disorder.

I am 24 years old or younger.

My blood pressure is higher than 140/90 at rest.

I am currently taking medications for depression or mood disorders.

I am not pregnant or breastfeeding.

Participant Groups

The study tests if psilocybin treatment helps with quitting cocaine by comparing it to diphenhydramine. It includes MRI scans to see if psilocybin changes brain connectivity or affects certain brain chemicals linked with addiction.

2Treatment groups

Experimental Treatment

Active Control

Group I: Psilocybin administrationExperimental Treatment1 Intervention

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.

Group II: Diphenhydramine administrationActive Control1 Intervention

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.

Psilocybin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Psilocybin for: