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Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

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ClinicalTrials.gov Identifier: NCT04982796
Recruitment Status : Not yet recruiting
First Posted : July 29, 2021
Last Update Posted : November 10, 2021
Sponsor:
Collaborator:
Steven and Alexandra Cohen Foundation
Information provided by (Responsible Party):
Portland VA Research Foundation, Inc

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.

Condition or disease Intervention/treatment Phase
Amphetamine-Related Disorders Drug: Psilocybin Behavioral: Treatment-as-usual Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Clinical interviewers will be blinded to condition and study timepoint.
Primary Purpose: Treatment
Official Title: Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
Estimated Study Start Date : January 15, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Experimental: Psilocybin-enhanced psychotherapy
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.
Drug: Psilocybin
See description of psilocybin-enhanced psychotherapy arm.

Behavioral: Treatment-as-usual
See description of treatment-as-usual arm.

Treatment-as-Usual
Treatment-as-usual while admitted to a residential rehabilitation treatment program.
Behavioral: Treatment-as-usual
See description of treatment-as-usual arm.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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, and IL-10

  17. Change from baseline in Immune Markers at 180 day post-discharge follow-up [ Time Frame: approximately 222 days post-enrollment ]
    C-Reactive Protein, IL-6, TNF-a, IL-8, and IL-10

  18. Change from baseline in Heart Rate Variability at end-of-intervention [ Time Frame: approximately 42 days post-enrollment ]
    heart rate variability, 5 minutes, resting

  19. Change from baseline in Heart Rate Variability at 180 day post-discharge follow-up [ Time Frame: approximately 222 days post-enrollment ]
    heart rate variability, 5 minutes, resting



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982796


Contacts
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Contact: Delaney McKechnie (360)696-4061 ext x32017 Delaney.McKechnie@va.gov

Sponsors and Collaborators
Portland VA Research Foundation, Inc
Steven and Alexandra Cohen Foundation
Investigators
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Principal Investigator: Chris Stauffer, MD Oregon Health and Science University
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Responsible Party: Portland VA Research Foundation, Inc
ClinicalTrials.gov Identifier: NCT04982796    
Other Study ID Numbers: 01
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Portland VA Research Foundation, Inc:
methamphetamine, stimulant, psilocybin, psychedelic, psychotherapy
Additional relevant MeSH terms:
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Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs