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Psychedelic

Psilocybin-Enhanced Psychotherapy for Methamphetamine Addiction

Phase 1 & 2
Recruiting
Led By Chris Stauffer, MD
Research Sponsored by Portland VA Research Foundation, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of seizure disorder in adulthood
CNS metastases or symptomatic central nervous system (CNS) infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether psilocybin, a drug found in magic mushrooms, can help people with methamphetamine addiction.

Who is the study for?
This trial is for individuals with moderate to severe methamphetamine use disorder who want to stop or cut down on their use. It's not suitable for those with uncontrolled high blood pressure, significant heart disease, seizures in adulthood, poorly controlled diabetes, certain medication regimes, bipolar I disorder, active eating disorders with purging behaviors, persistent psychotic disorders (like schizophrenia), hallucinogen use disorder, or those who are pregnant or breastfeeding.
What is being tested?
The study is testing if psilocybin-enhanced psychotherapy can help people with methamphetamine addiction better than the usual treatment methods. Participants will be randomly assigned to receive either the new therapy involving psilocybin or continue with standard treatments without it.
What are the potential side effects?
Psilocybin may cause temporary changes in perception and mood during administration. Other potential side effects include nausea and headache. Psychological support is provided during sessions to manage any discomfort.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had seizures as an adult.
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I have cancer spread to my brain or a brain infection with symptoms.
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I have high blood pressure or heart problems that aren't well-managed.
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My diabetes is not well-managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability
Proportion of patients who complete the intervention and follow-up
Secondary study objectives
Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention
Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up
Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up
+3 more
Other study objectives
Change from baseline in Anxiety Symptoms at 180 day post-discharge follow-up
Change from baseline in Anxiety Symptoms at 60 day post-discharge follow-up
Anxiety
+14 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%
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

2Treatment groups
Experimental Treatment
Group I: Treatment-as-UsualExperimental Treatment1 Intervention
Treatment-as-usual while admitted to a residential rehabilitation treatment program.
Group II: Psilocybin-enhanced psychotherapyExperimental Treatment2 Interventions
Psilocybin will be administered twice (25mg \& 30mg two weeks apart) in addition to a 6-week psychotherapy protocol while admitted to a residential rehabilitation treatment program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530
Treatment-as-usual
2020
Completed Phase 3
~900

Find a Location

Who is running the clinical trial?

Portland VA Research Foundation, IncLead Sponsor
1 Previous Clinical Trials
23 Total Patients Enrolled
Steven & Alexandra Cohen FoundationOTHER
9 Previous Clinical Trials
288 Total Patients Enrolled
Chris Stauffer, MDPrincipal InvestigatorOregon Health and Science University
2 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT04982796 — Phase 1 & 2
Amphetamine Use Disorder Research Study Groups: Psilocybin-enhanced psychotherapy, Treatment-as-Usual
Amphetamine Use Disorder Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT04982796 — Phase 1 & 2
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04982796 — Phase 1 & 2
Amphetamine Use Disorder Patient Testimony for trial: Trial Name: NCT04982796 — Phase 1 & 2
~1 spots leftby Dec 2024