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Psychedelic Therapy

Psilocybin for Opioid Use Disorder

Albuquerque, NM
Phase 2
Waitlist Available
Led By Michael Bogenschutz, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow capsules
Currently prescribed a methadone dose of at least 60 mg per day
Must not have
Allergy, hypersensitivity, or contraindication to adjunctive medications used in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the effects of different doses of psilocybin (a compound found in certain mushrooms) on patients with opioid use disorder (OUD) who are still using opioids despite receiving standard

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Who is the study for?
This trial is for individuals with Opioid Use Disorder who continue to use opioids despite being on methadone treatment. Participants will be part of a study evaluating the effects of different doses of psilocybin.Check my eligibility
What is being tested?
The trial tests moderate (20 mg) and high (30 mg) doses of psilocybin against a low-dose control (1 mg) in a two-stage process, assessing safety and potential efficacy in reducing opioid use over 24 weeks.See study design
What are the potential side effects?
While specific side effects are not listed, participants will be monitored for safety concerns related to varying doses of psilocybin, which may include changes in perception, mood swings, or other psychological effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills.
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I am taking 60 mg or more of methadone daily.
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I am between 18 and 65 years old.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to any medications used in this study.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Stage 1: The number of weeks during the 24 week follow-up period with no illicit opioid use
Stage 2: Score on the Negative Affect subscale of the Positive and Negative Affect Scale
Stage 2: Total score on the 20-item version of the Short Urgency, Premeditation, Perseverance, Sensation seeking, and Positive urgency (UPPS-P) Impulsive Behavior Scale (SUPPS-P)
+1 more
Secondary study objectives
Stage 2: Time to opioid relapse

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%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Stage 2: Psilocybin 30 mg (high dose)Experimental Treatment1 Intervention
Participants will receive a single IP administration (30 mg) session and remain under supervision at the facility for 8 hours.
Group II: Stage 2: Psilocybin 20 mg (medium dose)Experimental Treatment1 Intervention
Participants will receive a single IP administration (20 mg) session and remain under supervision at the facility for 8 hours.
Group III: Stage 1: Psilocybin 30 mg (high dose)Experimental Treatment1 Intervention
Participants will receive a single IP administration (30 mg) session and remain under supervision at the facility for 8 hours.
Group IV: Stage 1: Psilocybin 20 mg (medium dose)Experimental Treatment1 Intervention
Participants will receive a single IP administration (20 mg) session and remain under supervision at the facility for 8 hours.
Group V: Psilocybin 1 mg (control)Active Control1 Intervention
Participants will receive a single IP administration (1 mg) session and remain under supervision at the facility for 8 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Closest Location:University of New Mexico· Albuquerque, NM

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,641 Previous Clinical Trials
3,407,476 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,428 Previous Clinical Trials
834,472 Total Patients Enrolled
Michael Bogenschutz, MDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
300 Total Patients Enrolled
~320 spots leftby Mar 2029
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