Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Amphetamine-Related Disorders

Clinical Trial Details

NCT number	NCT04982796
Study type	Interventional
Source	Portland VA Research Foundation, Inc
Contact	Jenna Kachmarik, BS
Phone	(971) 409-7908
Email	Jenna.Kachmarik@va.gov
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	July 7, 2022
Completion date	April 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02232789` - Abuse Liability and Human Pharmacology of Mephedrone	Phase 1
Completed	`NCT01449565` - Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)	Phase 2
Completed	`NCT00247572` - Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories	Phase 2
Active, not recruiting	`NCT00100074` - To Assess the Safety and Tolerability of 7.5, 15 and 30 mg of Sublingual Lobeline. - 1	Phase 1
Active, not recruiting	`NCT00033072` - Assessment of Potential Interactions Between Methamphetamine and Selegiline - 1	Phase 1
Recruiting	`NCT06145698` - Treatment Effect of Cross-frequency Transcranial Alternating Current Stimulation on the MUD	N/A
Completed	`NCT00990067` - Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy)	Phase 1
Completed	`NCT02797990` - Conflict Between Maternal Autonomy and Child Health in Substance-use	N/A
Recruiting	`NCT01899313` - A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence	N/A
Active, not recruiting	`NCT00265278` - Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1	Phase 1
Active, not recruiting	`NCT00000350` - Effects of Stimulant Dependence on Human Striatal Dopamine System - 15	Phase 1
Active, not recruiting	`NCT00089440` - Assessment of Interactions Between Methamphetamine and Aripiprazole - 1	Phase 1
Active, not recruiting	`NCT00040040` - Assessment of Potential Interactions Between Methamphetamine and Bupropion - 1	Phase 1
Completed	`NCT00040053` - Ondansetron for the Treatment of Methamphetamine Dependence - 1	Phase 2
Completed	`NCT00895804` - Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)	Phase 1
Recruiting	`NCT03902405` - Computerized Exercise to Alter Stimulant Approach Responses	N/A
Completed	`NCT01386177` - Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA)	Phase 1
Completed	`NCT01136278` - Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA)	Phase 1
Completed	`NCT00069251` - Bupropion for the Treatment of Methamphetamine Dependence - 1	Phase 2
Completed	`NCT01270672` - Pharmacological Interaction Between Carvedilol and Methylenedioxymethamphetamine (MDMA)	N/A