Clinical TrialSubstance Use Disorders (SUD)PsilocybinActive not recruiting

Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder

Single-group, Phase I study (n=12) assessing two oral psilocybin doses (25 mg; second dose 25 or 50 mg) with behavioural support for adults with methamphetamine use disorder.

Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This single-group Phase I study evaluates the safety and feasibility of two oral psilocybin sessions given approximately 4 weeks apart, each delivered with trained facilitators and an overnight clinical observation period.

Participants receive preparatory psychological support (≥6 hours), an 8-hour dosing observation and overnight stay, and integration sessions; follow-up continues to approximately 26 weeks to assess safety and feasibility.

Study Protocol

Preparation

1 sessions
360 min each

Dosing

2 sessions
480 min each

Integration

2 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Oral Psilocybin

experimental

Psilocybin administered in capsules with psychological support; two doses ~4 weeks apart.

Interventions

  • Psilocybin25 - 50 mg
    via Oral• two sessions• 2 doses total

    Second dose 25 mg or 50 mg (per protocol)

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

  • Diagnosis of methamphetamine use disorder

Exclusion Criteria

  • Positive urine pregnancy at any time point during screening or study participation
  • Inadequately treated hypertension, defined as 2 blood pressure readings, 10 minutes apart, of greater than 140/90 mmHg systolic/diastolic
  • Current acute coronary syndrome or angina
  • History of heart transplant or stroke
  • Current use of and inability or unwillingness to taper off of medications that may interact with psilocybin
  • Current insulin dependence, due to Type I or Type II diabetes

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2022-04-18
    End: 2022-04-18
  • Compound
    Psilocybin
  • Topic
    Substance Use Disorders (SUD)

Locations

University of Wisconsin — Madison, Wisconsin, United States

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