Amphetamine-Related Disorders
Conditions
Keywords
methamphetamine, stimulant, psilocybin, psychedelic, psychotherapy
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.
Interventions
DRUGPsilocybin
See description of psilocybin-enhanced psychotherapy arm.
BEHAVIORALTreatment-as-usual
See description of treatment-as-usual arm.
Sponsors
Portland VA Research Foundation, Inc
Steven & Alexandra Cohen Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical interviewers will be blinded to condition and study timepoint.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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, urine | 60 days post-discharge follow-up; approximately 102 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChris Stauffer, MD
Oregon Health and Science University
Outcome results
None listed