Clinical TrialSubstance Use Disorders (SUD)KetamineKetaminePlaceboCompleted

Ketamine Psychoactive Effects in Cocaine Dependence: Double-Blind 3-Way Crossover Pilot (Dakwar / Nunes, NYSPI Columbia 2014)

This unregistered trial (n=8) was a double-blind, 3-way crossover pilot of ketamine infusions for cocaine dependence in cocaine-dependent adults, finding that acute mystical-type effects mediated improvements in the motivation to quit cocaine.

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Target Enrollment
8 participants
Study Type
interventional
Design
Randomized, double Blind

Detailed Description

This synthetic trial has been added to our database because a psychedelic paper (about a clinical trial) references this trial, but no (live) registration can be found.

The study employed a double-blind, 3-way crossover inpatient design to investigate whether the psychoactive effects of sub-anesthetic ketamine infusions influence therapeutic outcomes in cocaine dependence. Eight participants received either a low-dose ketamine infusion (0.41 mg/kg), a high-dose ketamine infusion (0.71 mg/kg), or an active control of lorazepam (2 mg), with infusions separated by 48 hours.

Researchers assessed dissociation, mystical-type effects, and cue-induced cocaine craving. The results demonstrated that ketamine induced significantly higher mystical-type effects compared to lorazepam, and that these mystical experiences mediated the observed increase in motivation to quit cocaine 24 hours after infusion.

Study Arms & Interventions

Ketamine 0.41mg/kg

experimental

Sub-anesthetic ketamine infusion (0.11 mg/kg bolus followed by 0.3 mg/kg slow-drip over 50 min)

Interventions

  • Ketamine0.41 mg/kg
    via IV• single dose• 1 doses total

    52-min infusion (2-min bolus followed by 50 min infusion)

Ketamine 0.71mg/kg

experimental

Sub-anesthetic ketamine infusion (0.11 mg/kg bolus followed by 0.6 mg/kg slow-drip over 50 min)

Interventions

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

    52-min infusion (2-min bolus followed by 50 min infusion)

Lorazepam 2mg

active comparator

Lorazepam infusion (saline bolus over 2 min followed by 2 mg slow-drip over 50 min)

Interventions

  • Placebo2 mg
    via IV• single dose• 1 doses total

    52-min infusion (2-min bolus followed by 50 min infusion)

Study Protocol, Arms & Participants

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Study Details

Locations

United States

Related Publications

Open AccessindividualSecondary analysis

Therapeutic infusions of ketamine: do the psychoactive effects matter?

This double-blind, randomised, inpatient study (n=8) evaluates the mystical and dissociative effects of ketamine in the treatment of cocaine dependant individuals. Ketamine led to significantly greater acute mystical-type effects than the active control, and mediated motivation to quit cocaine 24h post-infusion.

Published
Journal
Drug and Alcohol Dependence
Authors
Dakwar, E., Anerella, C., Hart, C. L., Levin, F. R., Mathew, S. J., Nunes, E. V.

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