Clinical TrialKetamineKetamineCompleted

Multiple vs Single Ketamine-Assisted Psychotherapy (KPT) for Heroin Dependence: Evaluator-Blind RCT (Krupitsky, St Petersburg Russia 2007)

Evaluator-blind randomised clinical study of multiple vs single ketamine-assisted psychotherapy (KPT) sessions for heroin dependence conducted post-inpatient detoxification (J Psychoactive Drugs 2007 Mar; Krupitsky EM, Burakov AM, Dunaevsky IV, Romanova TN, Slavina TY, Grinenko AY; St Petersburg, Russia; PMID 17523581; DOI 10.1080/02791072.2007.10399860). n=59 heroin-dependent adults (aged 18–35, dependent ≥1 year, ≥2 weeks abstinent); all received an initial IM ketamine session (2.0 mg/kg, psychedelic dose) during hospitalisation, plus 5 h preparatory and 5 h post-session psychotherapy (existentially oriented). After the first session, randomised to: multiple KPT (2 additional monthly KPT sessions + 1 h pre/post counselling each) vs single KPT (no further KPT, monthly counselling only). Primary outcome: abstinence from heroin over 12 months (Kaplan-Meier survival). Secondary outcomes: VASC (craving), ZDS (depression), SAS (anxiety), PLT (purpose in life); assessed monthly. Clinical evaluators blind to group assignment. No registration (pre-registration era, Russia 2007). CT.gov: 0 hits.

Target Enrollment
59 participants
Study Type
interventional
Design
Randomized, single Blind

Study Arms & Interventions

Multiple KPT group

experimental

Three ketamine-assisted psychotherapy (KPT) sessions with one-month intervals, plus addiction counseling sessions before the second and third KPT sessions.

Interventions

  • Ketamine2 mg/kg
    via IMthree sessions at monthly intervals3 doses total

    Sessions were 1.5 to 2 hours long; accompanied by psychotherapy.

Single KPT group

experimental

One ketamine-assisted psychotherapy (KPT) session followed by two addiction counseling sessions at one-month intervals.

Interventions

  • Ketamine2 mg/kg
    via IMsingle dose1 doses total

    Session was 1.5 to 2 hours long; accompanied by psychotherapy.

Primary Results(1 publication)

Participants

N = 53Mean age: 22.4–22.7 across armsM. et al. 2007

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Multiple KPT groupexperimental2626(100.0%)0(0.0%)0(0.0%)
Single KPT groupexperimental2727(100.0%)0(0.0%)0(0.0%)

* The only side effect noted in all participants was an acute increase in systolic and diastolic blood pressure of 20% to 30% during the ketamine psychotherapy session. No complications such as protracted psychosis or flashbacks were reported, and no participant became addicted to ketamine.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment59 participants
  • Timeline
    Start: 2004-01-01
    End: 2006-12-31
  • Compounds

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