Psychedelic
Psilocybin for Cocaine Use Disorder
UAB Outpatient Clinical Research Unit, Birmingham, AL
Psilocybin +1 morePhase 2RecruitingLed by Peter S. Hendricks, Ph.D.Research Sponsored by University of Alabama at BirminghamEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Score of at least 3 on the Severity of Dependence Scale
No prior hallucinogen use or it will have been at least 3 years since their last use of a hallucinogen
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upwithin 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
No Placebo-Only Group
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.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have a high level of dependence on the substance being studied, with a score of at least 3 on a scale that measures how reliant you are on it.
Select...
You haven't used hallucinogenic drugs in the past three years or have never used them before.
Select...
You want to stop using cocaine completely, as shown by your goal of not using cocaine anymore according to a questionnaire.
Select...
You want to stop using cocaine completely, according to your answers on the Thoughts about Abstinence questionnaire.
Select...
You have a dependence on a substance with a score of at least 3 on the Severity of Dependence Scale.
Select...
You have not used any hallucinogens before, or if you have, it has been at least 3 years since your last use.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
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 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT0206129344%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Depressed mood
6%
Insomnia
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Biopsy cervix
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Illusion
2%
Urinary incontinence
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Not yet FDA approved
Find a site
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,508 Previous Clinical Trials
2,256,521 Total Patients Enrolled
Peter S. Hendricks, Ph.D.Principal Investigator
UAB Department of PsychiatryMedia Library
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