Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Amphetamine-Related Disorders Clinical Trial

Official title:

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982796
• Other study ID #: 01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 7, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2023
• Source: Portland VA Research Foundation, Inc
• Contact: Jenna Kachmarik, BS
• Phone: (971) 409-7908
• Email: Jenna.Kachmarik[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amphetamine-Related Disorders

Intervention

Drug:
• Psilocybin
See description of psilocybin-enhanced psychotherapy arm.

Behavioral:
• Treatment-as-usual
See description of treatment-as-usual arm.

Locations

Country	Name	City	State
United States	Portland VA Health Care System	Vancouver	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Portland VA Research Foundation, Inc	Steven & Alexandra Cohen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in Stimulant Craving at end-of-intervention	Stimulant Craving Questionnaire-Brief	approximately 42 days post-enrollment
Other	Change from baseline in Stimulant Craving at 60 day post-discharge follow-up	Stimulant Craving Questionnaire-Brief	approximately 102 days post-enrollment
Other	Change from baseline in Stimulant Craving at 180 day post-discharge follow-up	Stimulant Craving Questionnaire-Brief	approximately 222 days post-enrollment
Other	Change from baseline in Depression Symptoms at end-of-intervention	Beck Depression Inventory-II	approximately 42 days post-enrollment
Other	Change from baseline in Depression Symptoms at 60 day post-discharge follow-up	Beck Depression Inventory-II	approximately 102 days post-enrollment
Other	Change from baseline in Depression Symptoms at 180 day post-discharge follow-up	Beck Depression Inventory-II	approximately 222 days post-enrollment
Other	Change from baseline in PTSD Symptoms at end-of-intervention	PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5	approximately 42 days post-enrollment
Other	Change from baseline in PTSD Symptoms at 60 day post-discharge follow-up	PTSD Checklist for DSM-5	approximately 102 days post-enrollment
Other	Change from baseline in PTSD Symptoms at 180 day post-discharge follow-up	PTSD Checklist for DSM-5	approximately 222 days post-enrollment
Other	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
Other	Change from baseline in Anxiety Symptoms at 60 day post-discharge follow-up	Generalized Anxiety Disorder-7	approximately 102 days post-enrollment
Other	Change from baseline in Anxiety Symptoms at 180 day post-discharge follow-up	Generalized Anxiety Disorder-7	approximately 222 days post-enrollment
Other	Change from baseline in Attachment Insecurity at end-of-intervention	Experiences in Close Relationships-Short form	approximately 42 days post-enrollment
Other	Change from baseline in Attachment Insecurity at 60 day post-discharge follow-up	Experiences in Close Relationships-Short form	approximately 102 days post-enrollment
Other	Change from baseline in Attachment Insecurity at 180 day post-discharge follow-up	Experiences in Close Relationships-Short form	approximately 222 days post-enrollment
Other	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-1ß, CCL2, CCL3	approximately 42 days post-enrollment
Other	Change from baseline in Heart Rate Variability at end-of-intervention	heart rate variability, 7 minutes, resting	approximately 42 days post-enrollment
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Methamphetamine Use, urine	Urine drug screen	60 days post-discharge follow-up; approximately 102 days post-enrollment
Secondary	Methamphetamine Use, urine	Urine drug screen	180 days post-discharge follow-up; approximately 222 days post-enrollment
Secondary	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
Secondary	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
Secondary	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