Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
- Conditions
- Amphetamine-Related Disorders
- Interventions
- Behavioral: Treatment-as-usual
- Registration Number
- NCT04982796
- Lead Sponsor
- Portland VA Research Foundation, Inc
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- United States military Veteran
- Moderate to severe methamphetamine use disorder using the DSM-V diagnostic criteria
- Desire to cease or reduce methamphetamine use
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psilocybin-enhanced psychotherapy Psilocybin 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. Psilocybin-enhanced psychotherapy Treatment-as-usual 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-as-Usual Treatment-as-usual Treatment-as-usual while admitted to a residential rehabilitation treatment program.
- Primary Outcome Measures
Name Time Method Acceptability End of 6-week intervention; approximately 42 days We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention.
Proportion of patients who complete the intervention and follow-up End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days We will observe the proportion of patients who complete the intervention and follow-up to determine feasibility.
- Secondary Outcome Measures
Name Time Method Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up approximately 102 days post-enrollment Sheehan Disability Scale total score, a measure of clinician-rated functional impairment
Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up approximately 222 days post-enrollment Sheehan Disability Scale total score, a measure of clinician-rated functional impairment
Methamphetamine Use, self-report 180 days post-discharge follow-up; approximately 222 days post-enrollment Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.
Methamphetamine Use, urine 180 days post-discharge follow-up; approximately 222 days post-enrollment Urine drug screen
Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention approximately 42 days post-enrollment Sheehan Disability Scale total score, a measure of clinician-rated functional impairment. SDS scores range from 0 (not impaired) to 30 (highly impaired).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 180 day post-discharge follow-up; approximately 222 days post-enrollment 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.
Trial Locations
- Locations (1)
Portland VA Health Care System
🇺🇸Vancouver, Washington, United States