RecruitingPhase 2ketamine

Ketamine for Methamphetamine Use Disorder

NCT ID

NCT06496750

Target Enrollment

120 participants

Start Date

2024-09-11

Est. Completion

2026-10-15

About This Study

This study aims to determine whether treatment response with IV ketamine is superior to treatment response with IV midazolam in adults with moderate to severe MUD. The study design is a 12-week randomized, double-blind, controlled trial comparing intravenous (IV) ketamine against IV midazolam, delivered over six weeks in 120 adults with moderate to severe methamphetamine use disorder (MUD).

Conditions Studied

Substance Use DisordersSubstance UseMethamphetamine Abuse

Interventions

•Ketamine Hydrochloride
•Midazolam Hydrochloride

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:No

View full eligibility criteria

Inclusion criteria

Study participants must:

1. Be 18 to 65 years old
2. Be able to sufficiently understand, speak, and read English
3. Be interested in reducing or stopping methamphetamine use
4. Meet criteria for methamphetamine use disorder
5. Use acceptable methods of contraception during participation in the study

Exclusion criteria

Study participants must not:

1. Have been in a research study of pharmacological or behavioral treatment for addiction within 6 months prior to written informed consent
2. Be currently in jail, prison, or inpatient overnight facility as required by court of law
3. Have upcoming surgery planned or scheduled
4. Be currently pregnant, breastfeeding, or planning on conception, if biologically female

Additional inclusion and exclusion criteria will be assessed by the study investigators at the screening visit.

Study Locations (4)

Interdisciplinary Substance Use and Brain Injury Facility

Albuquerque, New Mexico, United States

Addiction Institute of Mount Sinai

New York, New York, United States

Prisma Health

Greenville, South Carolina, United States

UT Southwestern Medical Center