Clinical TrialKetaminePlaceboCompleted

The Effect of Brief Potent Glutamatergic Modulation on Disordered Alcohol Use

Alcohol use disorders remain a significant public health problem. The pharmacological facilitation of behavioral treatment represents a promising strategy for addressing disordered drinking. Alcohol use disorders are recognized to be associated with various vulnerabilities that complicate the course of treatment and that may be amenable to glutamate modulators. The purpose of this randomized, double-blind, controlled trial is to test various glutamate modulators in conjunction with motivational enhancement therapy (MET) for alcohol use disorders.

Target Enrollment
50 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Study Arms & Interventions

Ketamine

experimental

52-minute intravenous infusion of ketamine (0.71 mg/kg) combined with motivational enhancement therapy.

Interventions

  • Ketamine0.71 mg/kg
    via IV• single dose• 1 doses total

    Includes a 2-minute 0.11 mg/kg bolus in saline followed by a 50-minute slow-drip infusion of 0.6 mg/kg.

Midazolam

active comparator

52-minute intravenous infusion of midazolam (0.025 mg/kg) combined with motivational enhancement therapy.

Interventions

  • Placebo0.025 mg/kg
    via IV• single dose• 1 doses total

    Includes a 2-minute saline bolus followed by a 50-minute slow-drip infusion.

Primary Results(2 publications)

Participants

N = 40Mean age: 50.4–55 across armsE. et al. 2020 →
N = 40Mean age: 50.4–55 across armsL. et al. 2020 →

Response Rates

Used alcohol (non-abstinence)

8/17(47.1%)·E. et al. 2020 →
13/22(59.1%)·E. et al. 2020 →

Reported abstinence

6/8(75.0%)·E. et al. 2020 →
3/11(27.3%)·E. et al. 2020 →

Had a heavy drinking day

3/17(17.6%)·E. et al. 2020 →
9/22(40.9%)·E. et al. 2020 →

Relapsed (first heavy drinking day or dropout)

3/17(17.6%)·E. et al. 2020 →
12/23(52.2%)·E. et al. 2020 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Ketamineexperimental1714(82.4%)—0(0.0%)0(0.0%)
Midazolamactive_comparator2316(69.6%)—0(0.0%)6(26.1%)
Ketamineexperimental170(0.0%)0(0.0%)0(0.0%)0(0.0%)
Midazolamactive_comparator230(0.0%)0(0.0%)0(0.0%)0(0.0%)

* Common adverse effects: sedation (N=8) and headache (N=6). Two participants experienced mild agitation lasting 1 hour postinfusion. No incidents of persistent psychoactive effects or drug misuse reported.

* Common adverse effects: sedation (N=12) and headache (N=4). Six participants dropped out of the midazolam group during the study period.

* No adverse events were reported for the Ketamine arm.

* No adverse events were reported for the Midazolam arm.

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment50 participants
  • Timeline
    Start: 2015-07-01
    End: 2017-12-01
  • Compounds
    KetaminePlacebo

Related Publications

A Single Ketamine Infusion Combined With Motivational Enhancement Therapy for Alcohol Use Disorder: A Randomized Midazolam-Controlled Pilot Trial

Published
Authors
Dakwar, E., Levin, F. R., Hart, C. L., Basaraba, C. N., Choi, J., Pavlicova, M., Nunes, E. V.

Mystical-type experiences occasioned by ketamine mediate its impact on at-risk drinking: Results from a randomized, controlled trial

Published
Authors
Rothberg, R. L., Azhari, N., Haug, N. A., Dakwar, E.

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