Clinical TrialParallelKetaminePlaceboCompleted

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.

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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.

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

Study Team

Sponsors & Collaborators

Related Publications

Open AccessindividualPrimary

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

This randomised, double-blind, active placebo-controlled pilot study (n=40) examined the effects of ketamine (49.7mg/70kg, n=17) or the active control midazolam (1.75mg/70kg, n=23) combined with motivational enhancement therapy to treat patients with alcohol use disorder. The preliminary data showed that a single ketamine infusion in combination with motivational enhancement therapy improves measures of drinking in patients with alcohol use disorder.

Published
Journal
American Journal of Psychiatry
Authors
Dakwar, E., Levin, F. R., Hart, C. L., Basaraba, C. N., Choi, J., Pavlicova, M., Nunes, E. V.
PaywallindividualSecondary analysis

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

In a randomised, controlled trial of 40 alcohol-dependent adults receiving ketamine or midazolam alongside motivational enhancement therapy, ketamine produced greater mystical-type experiences and reduced at-risk drinking. The mystical-type (but not dissociative) effects mediated ketamine’s impact on subsequent drinking behaviour.

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