Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Portland VA Research Foundation, Inc

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Amphetamine-Related Disorders

Treatments: Drug: Psilocybin; Behavioral: Treatment-as-usual

Study type: Interventional

Funder types: Other

Identifiers

NCT04982796

01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Psilocybin-enhanced psychotherapy

Experimental group

Description:

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:

Behavioral: Treatment-as-usual

Drug: Psilocybin

Treatment-as-Usual

Other group

Description:

Treatment-as-usual while admitted to a residential rehabilitation treatment program.

Treatment:

Behavioral: Treatment-as-usual