Ketamine Psychotherapy for Heroin Addiction: Double-Blind Dose-Comparison RCT (Krupitsky 2002, Leningrad Regional Centre of Addictions)
Double-blind randomised dose-comparison trial (J Subst Abuse Treat 2002; Krupitsky E, Burakov A, Romanova T, Dunaevsky I; Leningrad Regional Centre of Addictions, St. Petersburg, Russia; PMID 12495789). Participants: n=70 detoxified heroin-dependent inpatients randomised 1:1 to high-dose (n=35, 2.0 mg/kg IM ketamine) or low-dose active placebo (n=35, 0.20 mg/kg IM ketamine; sub-psychedelic). Both psychotherapist and subject blind to dose allocation; independent blinded rater assessed outcomes. Ketamine administered as part of a structured psychotherapy programme. 2-year follow-up for relapse/sobriety. Study submitted Dec 2002 — pre-dates the ICMJE 2005 prospective registration mandate. CT.gov: 0 hits; PubMed DataBankList: empty.
Study Arms & Interventions
High dose ketamine
experimentalExistentially oriented psychotherapy in combination with a hallucinogenic (psychedelic) dose of ketamine.
Interventions
- Ketamine2 mg/kgvia im• single dose• 1 doses total
Combined with existentially oriented psychotherapy
Low dose ketamine
active comparatorExistentially oriented psychotherapy in combination with a low, non-hallucinogenic (non-psychedelic) dose of ketamine, acting as an active placebo.
Interventions
- Ketamine0.2 mg/kgvia im• single dose• 1 doses total
Combined with existentially oriented psychotherapy; described as an active placebo condition
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| High dose ketamineexperimental | 35 | 35(100.0%) | 0(0.0%) | 0(0.0%) | 0(0.0%) |
| Low dose ketamineactive_comparator | 35 | 35(100.0%) | 0(0.0%) | 0(0.0%) | 0(0.0%) |
* All subjects in this arm experienced an acute increase in systolic and diastolic blood pressure (20-30%) during the ketamine session. No other side effects or complications (including protracted psychosis or flashbacks) were noted.