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Psychedelic

Psilocybin for Cocaine Use Disorder

Phase 2
Waitlist Available
Led By Peter S. Hendricks, Ph.D.
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
25 years of age and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.
Awards & highlights

Study Summary

This trial will study whether psilocybin can help people with cocaine addiction by looking at changes in the brain and measuring other relevant outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Psilocybin may cause psychological effects like altered perception, mood changes, and intense emotional experiences. Diphenhydramine can cause drowsiness, dry mouth, dizziness, and sometimes confusion or blurred vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't used cocaine or other drugs for at least 7 days.
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I am 25 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The difference between the psilocybin and placebo groups in sustained/complete abstinence from cocaine, verified by urine drug screen.
The difference between the psilocybin and placebo groups in the percentage of days abstinent from cocaine, verified by urine drug screen.
The difference between the psilocybin and placebo groups in time to cocaine lapse.
Secondary outcome measures
The difference between the psilocybin and placebo groups in cocaine craving.
The difference between the psilocybin and placebo groups in depression, anxiety, and stress.
The difference between the psilocybin and placebo groups in income, employment, and living situation.
+9 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,004 Total Patients Enrolled
Peter S. Hendricks, Ph.D.Principal InvestigatorUAB Department of Psychiatry

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT02037126 — Phase 2
Cocaine Use Disorder Research Study Groups: Diphenhydramine administration, Psilocybin administration
Cocaine Use Disorder Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT02037126 — Phase 2
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02037126 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
Florida
Alabama
Other
How old are they?
18 - 65
What site did they apply to?
UAB Outpatient Clinical Research Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I would like to be of help to the medical research community. I am desperately trying to find a treatment for my sons drug addiction. He said he is ready to get help also but we can't afford normal inpatient rehab.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Psilocybin-facilitated Treatment for Cocaine Use
Peter Hendricks 2015. "Psilocybin-facilitated Treatment for Cocaine Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02037126.
~4 spots leftby Apr 2025
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