Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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.
|
| Other: 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.
|
Outcome Measures
Primary Outcome Measures
- Acceptability [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.
- Proportion of patients who complete the intervention and follow-up [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
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [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.
- Methamphetamine Use, self-report [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 [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 [60 days post-discharge follow-up; approximately 102 days post-enrollment]
Urine drug screen
- Methamphetamine Use, urine [180 days post-discharge follow-up; approximately 222 days post-enrollment]
Urine drug screen
- Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention [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).
- Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up [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 [approximately 222 days post-enrollment]
Sheehan Disability Scale total score, a measure of clinician-rated functional impairment
Other Outcome Measures
- Change from baseline in Stimulant Craving at end-of-intervention [approximately 42 days post-enrollment]
Stimulant Craving Questionnaire-Brief
- Change from baseline in Stimulant Craving at 60 day post-discharge follow-up [approximately 102 days post-enrollment]
Stimulant Craving Questionnaire-Brief
- Change from baseline in Stimulant Craving at 180 day post-discharge follow-up [approximately 222 days post-enrollment]
Stimulant Craving Questionnaire-Brief
- Change from baseline in Depression Symptoms at end-of-intervention [approximately 42 days post-enrollment]
Beck Depression Inventory-II
- Change from baseline in Depression Symptoms at 60 day post-discharge follow-up [approximately 102 days post-enrollment]
Beck Depression Inventory-II
- Change from baseline in Depression Symptoms at 180 day post-discharge follow-up [approximately 222 days post-enrollment]
Beck Depression Inventory-II
- Change from baseline in PTSD Symptoms at end-of-intervention [approximately 42 days post-enrollment]
PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5
- Change from baseline in PTSD Symptoms at 60 day post-discharge follow-up [approximately 102 days post-enrollment]
PTSD Checklist for DSM-5
- Change from baseline in PTSD Symptoms at 180 day post-discharge follow-up [approximately 222 days post-enrollment]
PTSD Checklist for DSM-5
- Change from baseline in Anxiety Symptoms at end-of-intervention [approximately 42 days post-enrollment]
Measured by Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 (minimal anxiety) to 21 (severe anxiety).
- Change from baseline in Anxiety Symptoms at 60 day post-discharge follow-up [approximately 102 days post-enrollment]
Generalized Anxiety Disorder-7
- Change from baseline in Anxiety Symptoms at 180 day post-discharge follow-up [approximately 222 days post-enrollment]
Generalized Anxiety Disorder-7
- Change from baseline in Attachment Insecurity at end-of-intervention [approximately 42 days post-enrollment]
Experiences in Close Relationships-Short form
- Change from baseline in Attachment Insecurity at 60 day post-discharge follow-up [approximately 102 days post-enrollment]
Experiences in Close Relationships-Short form
- Change from baseline in Attachment Insecurity at 180 day post-discharge follow-up [approximately 222 days post-enrollment]
Experiences in Close Relationships-Short form
- Change from baseline in Immune Markers at end-of-intervention [approximately 42 days post-enrollment]
C-Reactive Protein, Interleukin (IL)-6, Tumor Necrosis Factor (TNF)-a, IL-8, IL-10, IL-1β, CCL2, CCL3
- Change from baseline in Heart Rate Variability at end-of-intervention [approximately 42 days post-enrollment]
heart rate variability, 7 minutes, resting
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Portland VA Health Care System | Vancouver | Washington | United States | 98661 |
Sponsors and Collaborators
- Portland VA Research Foundation, Inc
- Steven & Alexandra Cohen Foundation
Investigators
- Principal Investigator: Chris Stauffer, MD, Oregon Health and Science University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01