Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Brief 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.

Intervention / Treatment

  • Psilocybin (DRUG)
    See description of psilocybin-enhanced psychotherapy arm.
  • Treatment-as-usual (BEHAVIORAL)
    See description of treatment-as-usual arm.

Condition or Disease

  • Amphetamine-Related Disorders

Phase

  • Phase 1
  • Phase 2
  • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 25 Years to 65 Years
    Enrollment: 30 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical interviewers will be blinded to condition and study timepoint.

    SINGLE:
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 07, 2022 ACTUAL
    Primary Completion: Dec 31, 2024 ESTIMATED
    Completion Date: Apr 30, 2025 ESTIMATED
    Study First Posted: Jul 29, 2021 ACTUAL
    Last Updated: May 02, 2023

    Sponsors / Collaborators

    Lead sponsor is responsible party
    Responsible Party: N/A

    The trial will take place with individuals admitted to a residential rehabilitation treatment program. The treatment protocol will consist of 4 preparatory therapy visits, 2 psilocybin sessions (25-30mg), and 8 total integration therapy visits. Primary aims assess acceptability, feasibility, and safety with a primary endpoint at the conclusion of the study intervention. An additional aim assesses preliminary efficacy for methamphetamine use disorder and overall functioning at follow-up assessments 60 and 180 days after discharge from the residential treatment program.

    Participant Groups

    • Psilocybin will be administered twice (25mg \& 30mg two weeks apart) in addition to a 6-week psychotherapy protocol while admitted to a residential rehabilitation treatment program.

    • Treatment-as-usual while admitted to a residential rehabilitation treatment program.

    Eligibility Criteria

    Sex: All
    Minimum Age: 25
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes
    • We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention.

    • We will observe the proportion of patients who complete the intervention and follow-up to determine feasibility.

    Secondary Outcomes
    • Number of Participants Who Experienced Treatment-related Adverse Events as defined by the FDA (21 Code of Federal Regulations \[CFR\] 312.32(a)). Adverse events assessed at every study visit by clinical observation and patient interview.

    • Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.

    • Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.

    • Urine drug screen

    • Urine drug screen

    • Sheehan Disability Scale total score, a measure of clinician-rated functional impairment. SDS scores range from 0 (not impaired) to 30 (highly impaired).

    • Sheehan Disability Scale total score, a measure of clinician-rated functional impairment

    • Sheehan Disability Scale total score, a measure of clinician-rated functional impairment

    Other Outcomes
    • Stimulant Craving Questionnaire-Brief

    • Stimulant Craving Questionnaire-Brief

    • Stimulant Craving Questionnaire-Brief

    • Beck Depression Inventory-II

    • Beck Depression Inventory-II

    • Beck Depression Inventory-II

    • PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5

    • PTSD Checklist for DSM-5

    • PTSD Checklist for DSM-5

    • Measured by Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 (minimal anxiety) to 21 (severe anxiety).

    • Generalized Anxiety Disorder-7

    • Generalized Anxiety Disorder-7

    • Experiences in Close Relationships-Short form

    • Experiences in Close Relationships-Short form

    • Experiences in Close Relationships-Short form

    • C-Reactive Protein, Interleukin (IL)-6, Tumor Necrosis Factor (TNF)-a, IL-8, IL-10, IL-1β, CCL2, CCL3

    • heart rate variability, 7 minutes, resting

    More Details

    NCT Number: NCT04982796
    Other IDs: 01
    Study URL: https://clinicaltrials.gov/study/NCT04982796
    Last updated: Sep 29, 2023