Clinical TrialCrossoverKetaminePlaceboPlaceboCompleted

The Effect of Glutamatergic Modulation on Cocaine Self-administration

Repeated drug consumption may progress to problematic use by triggering neuroplastic adaptations that attenuate sensitivity to natural rewards while increasing reactivity to craving and drug cues. Converging evidence suggests that glutamate modulation may work to correct these adaptations and rapidly restore motivation for delayed non-drug rewards relative to immediate drug use. Using an established laboratory model aimed at evaluating behavioral shifts in the salience of cocaine now vs. money later, the investigators will test the effect of CI-581a on cocaine self-administration as compared to the active control.

Ask Blossom about this trial
Target Enrollment
Not specified
Study Type
Phase II interventional
Design
Randomized

Study Arms & Interventions

Ketamine

experimental

52-min sub-anesthetic intravenous infusion of ketamine hydrochloride

Interventions

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

    administered as 0.11 mg/kg 2-min bolus followed by 0.60 mg/kg in saline over 50 min

Midazolam

active comparator

52-min sub-anesthetic intravenous infusion of midazolam

Interventions

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

    administered as 2-min saline bolus followed by 0.025 mg/kg in saline infused over 50 min

Saline

placebo

52-min saline infusion during the first hospitalization to identify and exclude non-responders

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    used as a sham infusion in Inpatient Phase 1

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomized
  • Timeline
    Start: 2013-06-01
    End: 2015-07-01
  • Compounds
    KetaminePlaceboPlacebo

Study Team

Sponsors & Collaborators

Related Publications

Open AccessindividualPrimary

Cocaine self-administration disrupted by the N-methyl-D-aspartate receptor antagonist ketamine: a randomized, crossover trial

This active placebo-controlled, randomised, crossover, within-subjects study (n=20) investigated the effects of ketamine (49.7mg/70kg) on cocaine self-administration amongst medically healthy, non-treatment-seeking cocaine-dependent individuals. Faced with the choice to using cocaine (25mg) or receiving money ($11) after a single ketamine infusion, participants decreased cocaine self-administration by 67% and some of them maintained abstinence for at least 2 weeks after.

Published
Journal
Molecular Psychiatry
Authors
Dakwar, E., Hart, C. L., Levin, F. R., Nunes, E. V., Foltin, R. W.
Open AccessindividualSecondary analysis

A sub-set of psychoactive effects may be critical to the behavioral impact of ketamine on cocaine use disorder: results from a randomized, controlled laboratory study

This study (n=20) found that the mystical experience elicited by ketamine (but not dissociation or near-death-like experiences) may play an important role in ketamine's therapeutic potential for cocaine addiction.

Published
Journal
Neuropharmacology
Authors
Dakwar, E., Nunes, E. V., Hart, C. L., Foltin, R. W., Levin, F. R., Hu, M. C.