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| Name | Class |
|---|---|
| Steven & Alexandra Cohen Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin-enhanced psychotherapy | Experimental | 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 | Other | Treatment-as-usual while admitted to a residential rehabilitation treatment program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | See description of psilocybin-enhanced psychotherapy arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention. | 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. | End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 180 day post-discharge follow-up; approximately 222 days post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Stimulant Craving at end-of-intervention | Stimulant Craving Questionnaire-Brief | approximately 42 days post-enrollment |
| Change from baseline in Stimulant Craving at 60 day post-discharge follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Stauffer, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portland VA Health Care System | Vancouver | Washington | 98661 | United States |
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| ID | Term |
|---|---|
| D019969 | Amphetamine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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Clinical interviewers will be blinded to condition and study timepoint.
| Treatment-as-usual | Behavioral | See description of treatment-as-usual arm. |
|
| Methamphetamine Use, self-report | Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks. | 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. | 180 days post-discharge follow-up; approximately 222 days post-enrollment |
| Methamphetamine Use, urine | Urine drug screen | 60 days post-discharge follow-up; approximately 102 days post-enrollment |
| Methamphetamine Use, urine | Urine drug screen | 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). | 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 | 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 | approximately 222 days post-enrollment |
Stimulant Craving Questionnaire-Brief
| approximately 102 days post-enrollment |
| Change from baseline in Stimulant Craving at 180 day post-discharge follow-up | Stimulant Craving Questionnaire-Brief | approximately 222 days post-enrollment |
| Change from baseline in Depression Symptoms at end-of-intervention | Beck Depression Inventory-II | approximately 42 days post-enrollment |
| Change from baseline in Depression Symptoms at 60 day post-discharge follow-up | Beck Depression Inventory-II | approximately 102 days post-enrollment |
| Change from baseline in Depression Symptoms at 180 day post-discharge follow-up | Beck Depression Inventory-II | approximately 222 days post-enrollment |
| Change from baseline in PTSD Symptoms at end-of-intervention | PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 | approximately 42 days post-enrollment |
| Change from baseline in PTSD Symptoms at 60 day post-discharge follow-up | PTSD Checklist for DSM-5 | approximately 102 days post-enrollment |
| Change from baseline in PTSD Symptoms at 180 day post-discharge follow-up | PTSD Checklist for DSM-5 | approximately 222 days post-enrollment |
| Change from baseline in Anxiety Symptoms at end-of-intervention | Measured by Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 (minimal anxiety) to 21 (severe anxiety). | approximately 42 days post-enrollment |
| Change from baseline in Anxiety Symptoms at 60 day post-discharge follow-up | Generalized Anxiety Disorder-7 | approximately 102 days post-enrollment |
| Change from baseline in Anxiety Symptoms at 180 day post-discharge follow-up | Generalized Anxiety Disorder-7 | approximately 222 days post-enrollment |
| Change from baseline in Attachment Insecurity at end-of-intervention | Experiences in Close Relationships-Short form | approximately 42 days post-enrollment |
| Change from baseline in Attachment Insecurity at 60 day post-discharge follow-up | Experiences in Close Relationships-Short form | approximately 102 days post-enrollment |
| Change from baseline in Attachment Insecurity at 180 day post-discharge follow-up | Experiences in Close Relationships-Short form | approximately 222 days post-enrollment |
| Change from baseline in Immune Markers at end-of-intervention | C-Reactive Protein, Interleukin (IL)-6, Tumor Necrosis Factor (TNF)-a, IL-8, IL-10, IL-1β, CCL2, CCL3 | approximately 42 days post-enrollment |
| Change from baseline in Heart Rate Variability at end-of-intervention | heart rate variability, 7 minutes, resting | approximately 42 days post-enrollment |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |