Clinical TrialParallelOpioid Use Disorder (OUD)KetamineKetamineCompleted

Ketamine Psychotherapy for Heroin Addiction: Double-Blind Dose-Comparison RCT (Krupitsky 2002, Leningrad Regional Centre of Addictions)

This unregistered trial (n=70) was a double-blind, dose-comparison randomised controlled trial of high-dose versus low-dose ketamine combined with psychotherapy for heroin addiction in detoxified inpatients, which demonstrated significantly greater long-term abstinence and reduced craving in the high-dose group.

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Target Enrollment
70 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 evaluated the efficacy of ketamine-assisted psychotherapy for heroin addiction by comparing a hallucinogenic dose (2.0 mg/kg IM) against a sub-psychedelic, active placebo dose (0.2 mg/kg IM). Both groups received existentially oriented psychotherapy, including preparation, the ketamine session, and post-session integration to help patients apply insights to daily life.

Results from a two-year follow-up indicated that the high-dose group achieved significantly higher rates of abstinence and a more substantial, longer-lasting reduction in heroin cravings compared to the low-dose group. Additionally, the high-dose intervention was associated with greater positive changes in nonverbal unconscious emotional attitudes.

Study Arms & Interventions

High dose ketamine

experimental

Existentially oriented psychotherapy in combination with a hallucinogenic (psychedelic) dose of ketamine.

Interventions

  • Ketamine2 mg/kg
    via IM• single dose• 1 doses total

    Combined with existentially oriented psychotherapy

Low dose ketamine

active comparator

Existentially oriented psychotherapy in combination with a low, non-hallucinogenic (non-psychedelic) dose of ketamine, acting as an active placebo.

Interventions

  • Ketamine0.2 mg/kg
    via IM• single dose• 1 doses total

    Combined with existentially oriented psychotherapy; described as an active placebo condition

Study Protocol, Arms & Participants

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Study Details

Locations

Russia

Related Publications

Open AccessindividualPrimary

Ketamine psychotherapy for heroin addiction: immediate effects and two-year follow-up

This randomised double-blind clinical trial (2002, n=70) found that existential psychotherapy in combination with psychedelic doses of intramuscular (im) ketamine (140mg/70kg) achieved larger results in the treatment of heroin addiction than sub-hallucinogenic doses (14mg/70kg).

Published
Journal
Journal of Substance Abuse Treatment
Authors
Krupitsky, E. M., Burakov, A. M., Romanova, T. N., Dunaevsky, I. V., Strassman, R. J., Grinenko, A. Y.

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