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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 : July 29, 2021
Sponsor:
Collaborator:
Steven and Alexandra Cohen Foundation
Information provided by (Responsible Party):
Portland VA Research Foundation, Inc

Tracking Information
First Submitted Date  ICMJE July 19, 2021
First Posted Date  ICMJE July 29, 2021
Last Update Posted Date July 29, 2021
Estimated Study Start Date  ICMJE January 15, 2022
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2021)
  • 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.
  • Feasibility [ Time Frame: End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days ]
    Proportion of patients who complete the intervention and follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2021)
  • Safety [ 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 CFR 312.32(a)). Adverse events assessed at every study visit by clinical observation and patient interview.
  • 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.
  • 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.
  • Methamphetamine Use, urine [ Time Frame: 60 days post-discharge follow-up; approximately 102 days post-enrollment ]
    Urine drug screen
  • Methamphetamine Use, urine [ Time Frame: 180 days post-discharge follow-up; approximately 222 days post-enrollment ]
    Urine drug screen
  • Change from baseline in Sheehan Disability Scale at end-of-intervention [ Time Frame: approximately 42 days post-enrollment ]
    Sheehan Disability Scale total score, a measure of clinician-rated functional impairment
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 19, 2021)
  • Change from baseline in Stimulant Craving at end-of-intervention [ Time Frame: approximately 42 days post-enrollment ]
    Stimulant Craving Questionnaire-Brief
  • Change from baseline in Stimulant Craving at 60 day post-discharge follow-up [ Time Frame: approximately 102 days post-enrollment ]
    Stimulant Craving Questionnaire-Brief
  • Change from baseline in Stimulant Craving at 180 day post-discharge follow-up [ Time Frame: approximately 222 days post-enrollment ]
    Stimulant Craving Questionnaire-Brief
  • Change from baseline in Depression Symptoms at end-of-intervention [ Time Frame: approximately 42 days post-enrollment ]
    Beck Depression Inventory-II
  • Change from baseline in Depression Symptoms at 60 day post-discharge follow-up [ Time Frame: approximately 102 days post-enrollment ]
    Beck Depression Inventory-II
  • Change from baseline in Depression Symptoms at 180 day post-discharge follow-up [ Time Frame: approximately 222 days post-enrollment ]
    Beck Depression Inventory-II
  • Change from baseline in PTSD Symptoms at end-of-intervention [ Time Frame: approximately 42 days post-enrollment ]
    PTSD Checklist for DSM-5
  • 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
  • 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
  • Change from baseline in Anxiety Symptoms at end-of-intervention [ Time Frame: approximately 42 days post-enrollment ]
    Generalized Anxiety Disorder-7
  • Change from baseline in Anxiety Symptoms at 60 day post-discharge follow-up [ Time Frame: approximately 102 days post-enrollment ]
    Generalized Anxiety Disorder-7
  • Change from baseline in Anxiety Symptoms at 180 day post-discharge follow-up [ Time Frame: approximately 222 days post-enrollment ]
    Generalized Anxiety Disorder-7
  • Change from baseline in Attachment Insecurity at end-of-intervention [ Time Frame: approximately 42 days post-enrollment ]
    Experiences in Close Relationships-Short form
  • 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
  • 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
  • Change from baseline in Immune Markers at end-of-intervention [ Time Frame: approximately 42 days post-enrollment ]
    C-Reactive Protein, IL-6, TNF-a, IL-8, and IL-10
  • 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
  • Change from baseline in Heart Rate Variability at end-of-intervention [ Time Frame: approximately 42 days post-enrollment ]
    heart rate variability, 5 minutes, resting
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE Amphetamine-Related Disorders
Intervention  ICMJE
  • Drug: Psilocybin
    See description of psilocybin-enhanced psychotherapy arm.
  • Behavioral: Treatment-as-usual
    See description of treatment-as-usual arm.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Psilocybin
    • Behavioral: Treatment-as-usual
  • Treatment-as-Usual
    Treatment-as-usual while admitted to a residential rehabilitation treatment program.
    Intervention: Behavioral: Treatment-as-usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 19, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Delaney McKechnie (360)696-4061 ext x32017 Delaney.McKechnie@va.gov
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04982796
Other Study ID Numbers  ICMJE 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Portland VA Research Foundation, Inc
Study Sponsor  ICMJE Portland VA Research Foundation, Inc
Collaborators  ICMJE Steven and Alexandra Cohen Foundation
Investigators  ICMJE
Principal Investigator: Chris Stauffer, MD Oregon Health and Science University
PRS Account Portland VA Research Foundation, Inc
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP