Clinical TrialSubstance Use Disorders (SUD)PsilocybinRecruiting

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Proof-of-concept randomised clinical trial (n=30) of psilocybin-enhanced psychotherapy (two oral doses 25–30 mg) versus treatment-as-usual among veterans in residential treatment for methamphetamine use disorder.

Target Enrollment
30 participants
Study Type
Phase I/II interventional
Design
Randomized, single Blind

Detailed Description

Randomised, parallel-group study in veterans admitted to residential rehabilitation comparing psilocybin-enhanced psychotherapy (4 preparatory visits, 2 dosing sessions, 8 integration visits) with treatment-as-usual.

Primary aims are acceptability, feasibility, and safety with primary endpoint at end of intervention; secondary aims assess preliminary efficacy for methamphetamine use disorder and overall functioning at 60- and 180-day follow-ups.

Study Protocol

Preparation

4 sessions

Dosing

2 sessions

Integration

8 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin + therapy

experimental

Two psilocybin dosing sessions integrated into a residential psychotherapy protocol (preparation, dosing, integration).

Interventions

  • Psilocybin25 - 30 mg
    via Oral• two sessions• 2 doses total

    Doses 25–30 mg given two weeks apart; paired with preparatory and integration therapy.

Treatment-as-Usual

active comparator

Standard residential rehabilitation programme (behavioural treatment-as-usual).

Interventions

  • Compound
    via Other• ongoing

    Behavioural treatment-as-usual provided by residential programme.

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

  • Status
    Recruiting
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2022-01-15
    End: 2023-12-31
  • Compound
    Psilocybin
  • Topic
    Substance Use Disorders (SUD)

Locations

Portland VA Health Care System — Vancouver, Washington, United States

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