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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
See description of psilocybin-enhanced psychotherapy arm.
See description of treatment-as-usual arm.
Portland VA Health Care System
Vancouver, Washington, United States
RECRUITINGAcceptability
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
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.
Time frame: End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
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.
Time frame: 180 day post-discharge follow-up; approximately 222 days post-enrollment
Methamphetamine Use, self-report
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
Methamphetamine Use, self-report
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
Methamphetamine Use, urine
Urine drug screen
Time frame: 60 days post-discharge follow-up; approximately 102 days post-enrollment
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Methamphetamine Use, urine
Urine drug screen
Time frame: 180 days post-discharge follow-up; approximately 222 days post-enrollment
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).
Time frame: approximately 42 days post-enrollment
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
Time frame: approximately 102 days post-enrollment
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
Time frame: approximately 222 days post-enrollment