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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days

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

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

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

~950