Clinical trial NCT04982796: Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
Official title: Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Amphetamine-Related Disorders
Keywords: methamphetamine, stimulant, psilocybin, psychedelic, psychotherapy
Lead sponsor: Portland VA Research Foundation, Inc
Sponsor class: OTHER
Collaborators: name: Steven & Alexandra Cohen Foundation
First posted: 2021-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acceptability
timeFrame: End of 6-week intervention; approximately 42 days
measure: Proportion of patients who complete the intervention and follow-up
timeFrame: End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 180 day post-discharge follow-up; approximately 222 days post-enrollment
measure: Methamphetamine Use, self-report
timeFrame: 60 days post-discharge follow-up; approximately 102 days post-enrollment
measure: Methamphetamine Use, self-report
timeFrame: 180 days post-discharge follow-up; approximately 222 days post-enrollment
measure: Methamphetamine Use, urine
timeFrame: 60 days post-discharge follow-up; approximately 102 days post-enrollment
measure: Methamphetamine Use, urine
timeFrame: 180 days post-discharge follow-up; approximately 222 days post-enrollment
measure: Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention
timeFrame: approximately 42 days post-enrollment
measure: Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up
timeFrame: approximately 102 days post-enrollment
measure: Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up
timeFrame: approximately 222 days post-enrollment
Other outcomes:
measure: Change from baseline in Stimulant Craving at end-of-intervention
timeFrame: approximately 42 days post-enrollment
measure: Change from baseline in Stimulant Craving at 60 day post-discharge follow-up
timeFrame: approximately 102 days post-enrollment
measure: Change from baseline in Stimulant Craving at 180 day post-discharge follow-up
timeFrame: approximately 222 days post-enrollment
measure: Change from baseline in Depression Symptoms at end-of-intervention
timeFrame: approximately 42 days post-enrollment
measure: Change from baseline in Depression Symptoms at 60 day post-discharge follow-up
timeFrame: approximately 102 days post-enrollment
measure: Change from baseline in Depression Symptoms at 180 day post-discharge follow-up
timeFrame: approximately 222 days post-enrollment
measure: Change from baseline in PTSD Symptoms at end-of-intervention
timeFrame: approximately 42 days post-enrollment
measure: Change from baseline in PTSD Symptoms at 60 day post-discharge follow-up
timeFrame: approximately 102 days post-enrollment
measure: Change from baseline in PTSD Symptoms at 180 day post-discharge follow-up
timeFrame: approximately 222 days post-enrollment
measure: Change from baseline in Anxiety Symptoms at end-of-intervention
timeFrame: approximately 42 days post-enrollment
measure: Change from baseline in Anxiety Symptoms at 60 day post-discharge follow-up
timeFrame: approximately 102 days post-enrollment
measure: Change from baseline in Anxiety Symptoms at 180 day post-discharge follow-up
timeFrame: approximately 222 days post-enrollment
measure: Change from baseline in Attachment Insecurity at end-of-intervention
timeFrame: approximately 42 days post-enrollment
measure: Change from baseline in Attachment Insecurity at 60 day post-discharge follow-up
timeFrame: approximately 102 days post-enrollment
measure: Change from baseline in Attachment Insecurity at 180 day post-discharge follow-up
timeFrame: approximately 222 days post-enrollment
measure: Change from baseline in Immune Markers at end-of-intervention
timeFrame: approximately 42 days post-enrollment
measure: Change from baseline in Heart Rate Variability at end-of-intervention
timeFrame: approximately 42 days post-enrollment
Locations:
city: Vancouver
country: United States
facility: Portland VA Health Care System
state: Washington
Study officials:
affiliation: Oregon Health and Science University
name: Chris Stauffer, MD
role: PRINCIPAL_INVESTIGATOR
References: