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Active, Not Recruiting

NCT Number: NCT04982796

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Amphetamine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Portland VA Health Care System

Vancouver, Washington, 98661, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psilocybin

Drug

See description of psilocybin-enhanced psychotherapy arm.

Treatment-as-usual

Behavioral

See description of treatment-as-usual arm.

Primary outcomes

  1. Acceptability

    Time frame: End of 6-week intervention; approximately 42 days

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

  2. Proportion of patients who complete the intervention and follow-up

    Time frame: End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days

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

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 180 day post-discharge follow-up; approximately 222 days post-enrollment

    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.

  2. Methamphetamine Use, self-report

    Time frame: 60 days post-discharge follow-up; approximately 102 days post-enrollment

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

  3. Methamphetamine Use, self-report

    Time frame: 180 days post-discharge follow-up; approximately 222 days post-enrollment

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

  4. Methamphetamine Use, urine

    Time frame: 60 days post-discharge follow-up; approximately 102 days post-enrollment

    Urine drug screen

  5. Methamphetamine Use, urine

    Time frame: 180 days post-discharge follow-up; approximately 222 days post-enrollment

    Urine drug screen

  6. Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention

    Time frame: approximately 42 days post-enrollment

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

  7. Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up

    Time frame: approximately 102 days post-enrollment

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

  8. Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up

    Time frame: approximately 222 days post-enrollment

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

Other outcomes

  1. Change from baseline in Stimulant Craving at end-of-intervention

    Time frame: approximately 42 days post-enrollment

    Stimulant Craving Questionnaire-Brief

  2. Change from baseline in Stimulant Craving at 60 day post-discharge follow-up

    Time frame: approximately 102 days post-enrollment

    Stimulant Craving Questionnaire-Brief

  3. Change from baseline in Stimulant Craving at 180 day post-discharge follow-up

    Time frame: approximately 222 days post-enrollment

    Stimulant Craving Questionnaire-Brief

  4. Change from baseline in Depression Symptoms at end-of-intervention

    Time frame: approximately 42 days post-enrollment

    Beck Depression Inventory-II

  5. Change from baseline in Depression Symptoms at 60 day post-discharge follow-up

    Time frame: approximately 102 days post-enrollment

    Beck Depression Inventory-II

  6. Change from baseline in Depression Symptoms at 180 day post-discharge follow-up

    Time frame: approximately 222 days post-enrollment

    Beck Depression Inventory-II

  7. Change from baseline in PTSD Symptoms at end-of-intervention

    Time frame: approximately 42 days post-enrollment

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

  8. Change from baseline in PTSD Symptoms at 60 day post-discharge follow-up

    Time frame: approximately 102 days post-enrollment

    PTSD Checklist for DSM-5

  9. Change from baseline in PTSD Symptoms at 180 day post-discharge follow-up

    Time frame: approximately 222 days post-enrollment

    PTSD Checklist for DSM-5

  10. Change from baseline in Anxiety Symptoms at end-of-intervention

    Time frame: approximately 42 days post-enrollment

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

  11. Change from baseline in Anxiety Symptoms at 60 day post-discharge follow-up

    Time frame: approximately 102 days post-enrollment

    Generalized Anxiety Disorder-7

  12. Change from baseline in Anxiety Symptoms at 180 day post-discharge follow-up

    Time frame: approximately 222 days post-enrollment

    Generalized Anxiety Disorder-7

  13. Change from baseline in Attachment Insecurity at end-of-intervention

    Time frame: approximately 42 days post-enrollment

    Experiences in Close Relationships-Short form

  14. Change from baseline in Attachment Insecurity at 60 day post-discharge follow-up

    Time frame: approximately 102 days post-enrollment

    Experiences in Close Relationships-Short form

  15. Change from baseline in Attachment Insecurity at 180 day post-discharge follow-up

    Time frame: approximately 222 days post-enrollment

    Experiences in Close Relationships-Short form

  16. Change from baseline in Immune Markers at end-of-intervention

    Time frame: approximately 42 days post-enrollment

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

  17. Change from baseline in Heart Rate Variability at end-of-intervention

    Time frame: approximately 42 days post-enrollment

    heart rate variability, 7 minutes, resting

Sponsors and collaborators

Lead sponsor

Portland VA Research Foundation, Inc

Other

Collaborators

  • Steven & Alexandra Cohen Foundation

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2021
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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