Ketamine for Methamphetamine Use Disorder

Part of paid clinical trials in San Leandro, California.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06496750
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine Hydrochloride — DRUG
    Participants will receive IV ketamine (0.50mg/kg) dissolved in 0.9% sodium chloride in a total volume of 100mL and administered with an infusion pump over 45 minutes. Duration of each infusion may be extended by the Study Clinician supervising study medication infusion if slower infusion rate is better tolerated.
  • Midazolam Hydrochloride — DRUG
    Participants will receive IV midazolam (0.02mg/kg) dissolved in 0.9% sodium chloride in a total volume of 100mL and administered with an infusion pump over 45 minutes. Duration of each infusion may be extended by the Study Clinician supervising study medication infusion if slower infusion rate is better tolerated.

Study Details

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).

Key Dates

Start date
Sep 11, 2024
Status verified
Mar 2026
Primary completion
Aug 18, 2026
Completion
Oct 15, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketamine
    Participants will receive IV ketamine (0.50mg/kg) dissolved in 0.9% sodium chloride in a total volume of 100mL and administered with an infusion pump at a constant rate over 40 minutes. IV ketamine will be administered 8 times over 6 weeks.
  • Active Comparator: Midazolam
    Participants will receive IV midazolam (0.02mg/kg) dissolved in 0.9% sodium chloride in a total volume of 100mL and administered with an infusion pump at a constant rate over 40 minutes. IV midazolam will be administered 8 times over 6 weeks.

Primary Outcome Measure

Treatment Response [ Time Frame: 2 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Alameda Health SystemSan LeandroCalifornia94578
Stephanie Gallardo, BA
[email protected]
510-495-4643
Bridge Clinic
510-545-2765
Erik Anderson, MD (PRINCIPAL_INVESTIGATOR)
Interdisciplinary Substance Use and Brain Injury FacilityAlbuquerqueNew Mexico87106-
Addiction Institute of Mount SinaiNew YorkNew York10029-
Prisma HealthGreenvilleSouth Carolina29617
Sarah
[email protected]
864-960-3183
Anthony
[email protected]
864-735-8682
Alain Litwin, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75247-

Find similar trials in San Leandro, CA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Alameda Health System· San Leandro, CAInterdisciplinary Substance Use and Brain Injury Facility· Albuquerque, NMAddiction Institute of Mount Sinai· New York, NYPrisma Health· Greenville, SCUT Southwestern Medical Center· Dallas, TX

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