search
Back to results

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Primary Purpose

Amphetamine-Related Disorders

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Treatment-as-usual
Sponsored by
Portland VA Research Foundation, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine-Related Disorders focused on measuring methamphetamine, stimulant, psilocybin, psychedelic, psychotherapy

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Portland VA Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Psilocybin-enhanced psychotherapy

Treatment-as-Usual

Arm Description

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.

Outcomes

Primary Outcome Measures

Acceptability
We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention.
Proportion of patients who complete the intervention and follow-up
We will observe the proportion of patients who complete the intervention and follow-up to determine feasibility.

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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.
Methamphetamine Use, self-report
Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.
Methamphetamine Use, self-report
Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.
Methamphetamine Use, urine
Urine drug screen
Methamphetamine Use, urine
Urine drug screen
Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention
Sheehan Disability Scale total score, a measure of clinician-rated functional impairment. SDS scores range from 0 (not impaired) to 30 (highly impaired).
Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up
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
Sheehan Disability Scale total score, a measure of clinician-rated functional impairment

Full Information

First Posted
July 19, 2021
Last Updated
May 2, 2023
Sponsor
Portland VA Research Foundation, Inc
Collaborators
Steven & Alexandra Cohen Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT04982796
Brief Title
Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
Official Title
Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Portland VA Research Foundation, Inc
Collaborators
Steven & Alexandra Cohen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders
Keywords
methamphetamine, stimulant, psilocybin, psychedelic, psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Clinical interviewers will be blinded to condition and study timepoint.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psilocybin-enhanced psychotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment-as-Usual
Arm Type
Other
Arm Description
Treatment-as-usual while admitted to a residential rehabilitation treatment program.
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
See description of psilocybin-enhanced psychotherapy arm.
Intervention Type
Behavioral
Intervention Name(s)
Treatment-as-usual
Intervention Description
See description of treatment-as-usual arm.
Primary Outcome Measure Information:
Title
Acceptability
Description
We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention.
Time Frame
End of 6-week intervention; approximately 42 days
Title
Proportion of patients who complete the intervention and follow-up
Description
We will observe the proportion of patients who complete the intervention and follow-up to determine feasibility.
Time Frame
End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
180 day post-discharge follow-up; approximately 222 days post-enrollment
Title
Methamphetamine Use, self-report
Description
Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.
Time Frame
60 days post-discharge follow-up; approximately 102 days post-enrollment
Title
Methamphetamine Use, self-report
Description
Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.
Time Frame
180 days post-discharge follow-up; approximately 222 days post-enrollment
Title
Methamphetamine Use, urine
Description
Urine drug screen
Time Frame
60 days post-discharge follow-up; approximately 102 days post-enrollment
Title
Methamphetamine Use, urine
Description
Urine drug screen
Time Frame
180 days post-discharge follow-up; approximately 222 days post-enrollment
Title
Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention
Description
Sheehan Disability Scale total score, a measure of clinician-rated functional impairment. SDS scores range from 0 (not impaired) to 30 (highly impaired).
Time Frame
approximately 42 days post-enrollment
Title
Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up
Description
Sheehan Disability Scale total score, a measure of clinician-rated functional impairment
Time Frame
approximately 102 days post-enrollment
Title
Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up
Description
Sheehan Disability Scale total score, a measure of clinician-rated functional impairment
Time Frame
approximately 222 days post-enrollment
Other Pre-specified Outcome Measures:
Title
Change from baseline in Stimulant Craving at end-of-intervention
Description
Stimulant Craving Questionnaire-Brief
Time Frame
approximately 42 days post-enrollment
Title
Change from baseline in Stimulant Craving at 60 day post-discharge follow-up
Description
Stimulant Craving Questionnaire-Brief
Time Frame
approximately 102 days post-enrollment
Title
Change from baseline in Stimulant Craving at 180 day post-discharge follow-up
Description
Stimulant Craving Questionnaire-Brief
Time Frame
approximately 222 days post-enrollment
Title
Change from baseline in Depression Symptoms at end-of-intervention
Description
Beck Depression Inventory-II
Time Frame
approximately 42 days post-enrollment
Title
Change from baseline in Depression Symptoms at 60 day post-discharge follow-up
Description
Beck Depression Inventory-II
Time Frame
approximately 102 days post-enrollment
Title
Change from baseline in Depression Symptoms at 180 day post-discharge follow-up
Description
Beck Depression Inventory-II
Time Frame
approximately 222 days post-enrollment
Title
Change from baseline in PTSD Symptoms at end-of-intervention
Description
PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5
Time Frame
approximately 42 days post-enrollment
Title
Change from baseline in PTSD Symptoms at 60 day post-discharge follow-up
Description
PTSD Checklist for DSM-5
Time Frame
approximately 102 days post-enrollment
Title
Change from baseline in PTSD Symptoms at 180 day post-discharge follow-up
Description
PTSD Checklist for DSM-5
Time Frame
approximately 222 days post-enrollment
Title
Change from baseline in Anxiety Symptoms at end-of-intervention
Description
Measured by Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 (minimal anxiety) to 21 (severe anxiety).
Time Frame
approximately 42 days post-enrollment
Title
Change from baseline in Anxiety Symptoms at 60 day post-discharge follow-up
Description
Generalized Anxiety Disorder-7
Time Frame
approximately 102 days post-enrollment
Title
Change from baseline in Anxiety Symptoms at 180 day post-discharge follow-up
Description
Generalized Anxiety Disorder-7
Time Frame
approximately 222 days post-enrollment
Title
Change from baseline in Attachment Insecurity at end-of-intervention
Description
Experiences in Close Relationships-Short form
Time Frame
approximately 42 days post-enrollment
Title
Change from baseline in Attachment Insecurity at 60 day post-discharge follow-up
Description
Experiences in Close Relationships-Short form
Time Frame
approximately 102 days post-enrollment
Title
Change from baseline in Attachment Insecurity at 180 day post-discharge follow-up
Description
Experiences in Close Relationships-Short form
Time Frame
approximately 222 days post-enrollment
Title
Change from baseline in Immune Markers at end-of-intervention
Description
C-Reactive Protein, Interleukin (IL)-6, Tumor Necrosis Factor (TNF)-a, IL-8, IL-10, IL-1β, CCL2, CCL3
Time Frame
approximately 42 days post-enrollment
Title
Change from baseline in Heart Rate Variability at end-of-intervention
Description
heart rate variability, 7 minutes, resting
Time Frame
approximately 42 days post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenna Kachmarik, BS
Phone
(971) 409-7908
Email
Jenna.Kachmarik@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Rothstein-Kightly, MS
Phone
(360) 450-9349
Email
Kevin.Rothstein-Kightly@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Stauffer, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portland VA Health Care System
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98661
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Rothstein-Kightly, BS
Phone
360-450-9349
Email
Kevin.Rothstein-Kightly@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

We'll reach out to this number within 24 hrs