Psilocybin therapy for treating methamphetamine addiction
Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
This study is testing whether therapy combined with psilocybin can help people with methamphetamine addiction do better than standard treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Portland VA Research Foundation, Inc Academic / other |
| Locations | 1 site (Vancouver, Washington) |
| Trial ID | NCT04982796 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of psilocybin-enhanced psychotherapy compared to standard treatment for individuals with methamphetamine use disorder. Participants will undergo a structured treatment protocol that includes preparatory therapy sessions, two psilocybin sessions, and follow-up integration therapy visits. The study aims to assess the acceptability, feasibility, and safety of this approach, along with its preliminary efficacy in reducing methamphetamine use and improving overall functioning. Follow-up assessments will occur 60 and 180 days after discharge from the rehabilitation program.
Who should consider this trial
Good fit: Ideal candidates are United States military veterans with moderate to severe methamphetamine use disorder who wish to reduce or cease their use.
Not a fit: Patients with uncontrolled hypertension, significant cardiovascular disease, or a history of certain psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for individuals struggling with methamphetamine addiction.
How similar studies have performed: Other studies have shown promising results with psychedelic-assisted therapies, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vancouver, Washington
- Portland VA Health Care System — Vancouver, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Chris Stauffer, MD — Oregon Health and Science University
- Study coordinator: Bianca Watt, MSc
- Email: Bianca.Watt@va.gov
- Phone: (503) 781-1205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.