Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Study Overview
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Brief Summary
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This is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder.

Detailed Description
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The trial will take place with individuals admitted to a residential rehabilitation treatment program. The treatment protocol will consist of 4 preparatory therapy visits, 2 psilocybin sessions (25-30mg), and 8 total integration therapy visits. Primary aims assess acceptability, feasibility, and safety with a primary endpoint at the conclusion of the study intervention. An additional aim assesses preliminary efficacy for methamphetamine use disorder and overall functioning at follow-up assessments 60 and 180 days after discharge from the residential treatment program.

Official Title
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Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Conditions
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Amphetamine-Related Disorders

Intervention / Treatment
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* Drug: Psilocybin
* Behavioral: Treatment-as-usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: United States military Veteran Moderate to severe methamphetamine use disorder using the DSM-V diagnostic criteria Desire to cease or reduce methamphetamine use Exclusion Criteria: Have uncontrolled hypertension or clinically significant cardiovascular disease History of seizure disorder in adulthood CNS metastases or symptomatic central nervous system (CNS) infection Poorly controlled diabetes mellitus Taking certain medications that may interact with psilocybin History of any primary persistent psychotic disorder, including schizophrenia, schizoaffective disorder, bipolar disorder with psychosis, major depressive disorder with psychosis, or schizophreniform disorder History of bipolar I disorder Current eating disorder with active purging History of hallucinogen use disorder Pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psilocybin-enhanced psychotherapy<br>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. | Drug: Psilocybin<br>* See description of psilocybin-enhanced psychotherapy arm.<br>Behavioral: Treatment-as-usual<br>* See description of treatment-as-usual arm.<br>|
| Other: Treatment-as-Usual<br>Treatment-as-usual while admitted to a residential rehabilitation treatment program. | Behavioral: Treatment-as-usual<br>* See description of treatment-as-usual arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention. | End of 6-week intervention; approximately 42 days | 
| Proportion of patients who complete the intervention and follow-up | We will observe the proportion of patients who complete the intervention and follow-up to determine feasibility. | End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of Participants Who Experienced Treatment-related Adverse Events as defined by the FDA (21 Code of Federal Regulations [CFR] 312.32(a)). Adverse events assessed at every study visit by clinical observation and patient interview. | 180 day post-discharge follow-up; approximately 222 days post-enrollment | 
| Methamphetamine Use, self-report | Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks. | 60 days post-discharge follow-up; approximately 102 days post-enrollment | 
| Methamphetamine Use, self-report | Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks. | 180 days post-discharge follow-up; approximately 222 days post-enrollment | 
| Methamphetamine Use, urine | Urine drug screen | 60 days post-discharge follow-up; approximately 102 days post-enrollment | 
| Methamphetamine Use, urine | Urine drug screen | 180 days post-discharge follow-up; approximately 222 days post-enrollment | 
| Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention | Sheehan Disability Scale total score, a measure of clinician-rated functional impairment. SDS scores range from 0 (not impaired) to 30 (highly impaired). | approximately 42 days post-enrollment | 
| Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up | Sheehan Disability Scale total score, a measure of clinician-rated functional impairment | approximately 102 days post-enrollment | 
| Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up | Sheehan Disability Scale total score, a measure of clinician-rated functional impairment | approximately 222 days post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methamphetamine, stimulant, psilocybin, psychedelic, psychotherapy