Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder (NCT04982796) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
United States30 participantsStarted 2022-07-07
Plain-language 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.
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability
Timeframe: End of 6-week intervention; approximately 42 days
2
Proportion of patients who complete the intervention and follow-up
Timeframe: End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days