~0 spots leftby May 2025

Psilocybin for Methamphetamine Addiction

Recruiting in Palo Alto (17 mi)
Overseen ByChristopher Nicholas, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: University of Wisconsin, Madison
No Placebo Group
Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests if psilocybin pills, combined with counseling, are safe for adults addicted to methamphetamine. Psilocybin can change brain function temporarily, helping people see their addiction differently. Counseling supports participants in understanding and using these new insights to aid their recovery. Psilocybin has shown potential in treating addiction, including nicotine and alcohol addiction, and has been studied for its effects on depression and anxiety.

Eligibility Criteria

This trial is for adults with methamphetamine use disorder who've used meth less than 16 days in the past month. It's not for those with insulin-dependent diabetes, pregnant individuals, untreated high blood pressure, a history of heart transplant or stroke, current severe heart issues, or those on certain medications.

Inclusion Criteria

I have been diagnosed with mild or moderate meth use disorder, using it less than 16 days last month.
Diagnosis of methamphetamine use disorder with meth use reported for less than 16 days in the past month

Exclusion Criteria

I have had a heart transplant or a stroke.
I am using medications that cannot be mixed with psilocybin and cannot stop.
I am currently experiencing heart-related chest pain.
+3 more

Participant Groups

The study tests the safety and practicality of two oral doses of psilocybin alongside behavioral support over approximately six months. Psilocybin is given to see if it can help people with methamphetamine addiction.
1Treatment groups
Experimental Treatment
Group I: Oral PsilocybinExperimental Treatment1 Intervention
Psilocybin with psychological support: Psilocybin will be administered in the form of capsules, taken orally with water. Each participant will receive 2 doses, approximately 4 weeks apart.

Psilocybin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Psilocybin for:
  • Treatment-resistant depression (TRD) under Breakthrough Therapy designation
🇪🇺 Approved in European Union as Psilocybin for:
  • Treatment-resistant depression (TRD) under PRIME designation

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
University of WisconsinMadison, WI
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Who Is Running the Clinical Trial?

University of Wisconsin, MadisonLead Sponsor
Revive Therapeutics, Ltd.Industry Sponsor

References