Clinical trial NCT06496750: Ketamine for Methamphetamine Use Disorder
Official title: NIDA CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for Methamphetamine Use Disorder (KMD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Substance Use Disorders
Substance Use
Methamphetamine Abuse
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Effective management for methamphetamine use disorder (MUD) remains elusive, despite widespread misuse of this stimulant. Psychological interventions have demonstrated modest benefits, and relapse rates are high. There are currently no Food and Drug Administration (FDA)-approved pharmacotherapies for MUD. This study explores the efficacy, safety, and feasibility for intravenous (IV) ketamine as a treatment for MUD and will help to determine the effect size for a larger, multi-site trial of intravenous (IV) ketamine in MUD.

Participants will receive either IV ketamine (0.50mg/kg) or IV midazolam (0.02mg/kg) over 45 minutes per infusion for a total of eight (8) infusions over six (6) weeks. Medical management sessions with a study clinician will be provided to all participants once weekly (from Weeks 1 through 6).

The use of IV ketamine in this trial is consistent in dose (0.5 mg/kg) and duration of infusion (45-minute-long) to other studies of ketamine for psychiatric disorders (such as major depressive disorder and post-traumatic stress disorder, both of which are often comorbid in individuals with MUD) and substance use disorder. However, IV ketamine has not been directly evaluated as mono-pharmacotherapy in those with MUD yet.

Additionally, participants will be asked to participate in cognitive behavioral therapy (CBT) sessions once weekly (from Weeks 1 through 12) on a non-infusion day.

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.

Primary outcomes:
measure: Treatment Response
timeFrame: 2 weeks
Secondary outcomes:
measure: Non-serious adverse outcomes associated with IV ketamine treatment for methamphetamine use
timeFrame: 6 weeks
measure: Adherence to treatment
timeFrame: 6 weeks
measure: Total abstinence
timeFrame: 2 weeks
measure: Abstinence from methamphetamine use
timeFrame: 12 weeks
measure: Differences in methamphetamine-negative urine samples from Weeks 1 to 6 and between ketamine and midazolam arms.
timeFrame: 6 weeks
measure: Differences in methamphetamine-negative urine samples from Weeks 1 and 2 versus Weeks 3 and 4.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Interdisciplinary Substance Use and Brain Injury Facility
state: New Mexico
city: New York
country: United States
facility: Addiction Institute of Mount Sinai
state: New York
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Associate Professor
name: Manish Jha, MBBS
role: PRINCIPAL_INVESTIGATOR
References: