Clinical TrialParallelKetamineTerminated

The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence

This project will evaluate the effect of a single sub-anesthetic dose of ketamine on the time to first cocaine use and abstinence rates in 60 treatment-seeking cocaine-dependent individuals receiving mindfulness-based relapse prevention (MBRP) therapy, using a 5 week combined laboratory-inpatient and outpatient double-blind, randomized, controlled trial.

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Target Enrollment
55 participants
Study Type
Phase I/II interventional
Design
Randomized, quadruple Blind

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Related paper: A single ketamine infusion combined with mindfulness-based behavioral modification to treat cocaine dependence: a randomized clinical trialCompound research: Ketamine

Study Arms & Interventions

Ketamine 35 mg/70 kg

experimental

A single 40-minute intravenous infusion of ketamine (0.5 mg/kg) combined with a 5-week course of mindfulness-based relapse prevention (MBRP).

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    40-minute slow-drip infusion; combined with MBRP

Midazolam 1.8 mg/70 kg (active comparator)

active comparator

A single 40-minute intravenous infusion of midazolam (0.025 mg/kg) combined with a 5-week course of mindfulness-based relapse prevention (MBRP).

Interventions

  • Compound0.025 mg/kg
    via IV• single dose• 1 doses total

    40-minute slow-drip infusion; used as active control; combined with MBRP

Study Protocol, Arms & Participants

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Study Details

  • Status
    Terminated
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment55 participants
  • Timeline
    Start: 2012-02-01
    End: 2017-04-01
  • Compound
    Ketamine

Study Team

Sponsors & Collaborators

Investigators

  • ED
    Elias Dakwar

Related Publications

Open AccessindividualPrimary

A single ketamine infusion combined with mindfulness-based behavioral modification to treat cocaine dependence: a randomized clinical trial

This double-blind, placebo-controlled study (n=55) investigated the use of ketamine (35mg/70kg) versus midazolam (an anesthetic), plus mindfulness-based therapy (5-week program) for cocaine dependence. The ketamine group scored significantly better and were 53% less likely to relapse.

Published
Journal
American Journal of Psychiatry
Authors
Dakwar, E., Nunes, E. V., Hart, C. L., Foltin, R. W., Mathew, S. J., Carpenter, K. M., Choi, J. "., Basaraba, C. N., Pavlicova, M., Levin, F. R.

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