Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
- Conditions
- Amphetamine-Related Disorders
- Registration Number
- NCT04982796
- Lead Sponsor
- Portland VA Research Foundation, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria:<br><br> - United States military Veteran<br><br> - Moderate to severe methamphetamine use disorder using the DSM-V diagnostic criteria<br><br> - Desire to cease or reduce methamphetamine use<br><br>Exclusion Criteria:<br><br> - Have uncontrolled hypertension or clinically significant cardiovascular disease<br><br> - History of seizure disorder in adulthood<br><br> - CNS metastases or symptomatic central nervous system (CNS) infection<br><br> - Poorly controlled diabetes mellitus<br><br> - Taking certain medications that may interact with psilocybin<br><br> - History of any primary persistent psychotic disorder, including schizophrenia,<br> schizoaffective disorder, bipolar disorder with psychosis, major depressive disorder<br> with psychosis, or schizophreniform disorder<br><br> - History of bipolar I disorder<br><br> - Current eating disorder with active purging<br><br> - History of hallucinogen use disorder<br><br> - Pregnant or breast feeding
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acceptability;Proportion of patients who complete the intervention and follow-up
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability];Methamphetamine Use, self-report;Methamphetamine Use, self-report;Methamphetamine Use, urine;Methamphetamine Use, urine;Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention;Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up;Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up