Ketamine for Methamphetamine Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be 18 to 65 years old
Be able to sufficiently understand, speak, and read English
Be interested in reducing or stopping methamphetamine use
Meet criteria for methamphetamine use disorder
Disqualifiers
Have been in a research study of pharmacological or behavioral treatment for addiction within 6 months prior to written informed consent
Be currently in jail, prison, or inpatient overnight facility as required by court of law
Have upcoming surgery planned or scheduled
Be currently pregnant, breastfeeding, or planning on conception, if biologically female
Trial design
Design model
Parallel
Treatments tested in this trial
Ketamine Hydrochloride
DrugParticipants 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
DrugParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: KetamineExperimental treatment 1 intervention
Group B: MidazolamActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Response
Defined as having at least three methamphetamine-negative urine samples out of four samples obtained during Weeks 3 and 4.
Time frame
2 weeksSecondary outcomes
1
Non-serious adverse outcomes associated with IV ketamine treatment for methamphetamine use
Defined by non-serious adverse events (associated with the IV ketamine treatment) reported during the study intervention phase (weeks 1 to 6). Participants will be assessed for adverse events at each study visit.
Time frame
6 weeks2
Adherence to treatment
Defined by completion of at least five out of eight IV ketamine or IV midazolam infusions.
Time frame
6 weeks3
Total abstinence
Defined as four out of four methamphetamine-negative urine samples obtained during Weeks 3 and 4 (since missing urine drug screens will be counted as positive).
Time frame
2 weeks4
Abstinence from methamphetamine use
Defined by the self-reported days of methamphetamine use as reported on the Timeline Followback (TLFB) from Week 1 to Week 4, Week 5 to Week 6, and Week 7 to Week 12.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov