Ketamine Psychoactive Effects in Cocaine Dependence: Double-Blind 3-Way Crossover Pilot (Dakwar / Nunes, NYSPI Columbia 2014)
Double-blind, randomised, 3-way crossover inpatient mechanistic pilot in cocaine dependence (Drug Alcohol Depend 2014 Mar; Dakwar E, Anerella C, Hart CL, Levin FR, Mathew SJ, Nunes EV; New York State Psychiatric Institute / Columbia University; PMID 24480515; DOI 10.1016/j.drugalcdep.2013.12.019). n=8 cocaine-dependent adults, not seeking treatment; 9-day inpatient; abstinent days 1–3 before randomisation to infusion order. Three 52-min IV infusions separated by 48 h (constrained so K1 always precedes K2): K1 – ketamine 0.41 mg/kg (0.11 mg/kg bolus + 0.3 mg/kg over 50 min); K2 – ketamine 0.71 mg/kg (0.11 mg/kg bolus + 0.6 mg/kg slow drip); LZP – lorazepam 2 mg (saline bolus + 2 mg over 50 min; active control). Primary outcomes: URICA (motivation-to-quit) and cue-induced craving (VAS during 15-min cocaine cue exposure) at 24 h post-infusion. Mystical phenomena (HMS), CADSS, drug liking VAS also assessed. No CT.gov registration; no DataBankList in PubMed.
Study Arms & Interventions
Ketamine 0.41mg/kg
experimentalSub-anesthetic ketamine infusion (0.11 mg/kg bolus followed by 0.3 mg/kg slow-drip over 50 min)
Interventions
- Ketamine0.41 mg/kgvia IV• single dose• 1 doses total
52-min infusion (2-min bolus followed by 50 min infusion)
Ketamine 0.71mg/kg
experimentalSub-anesthetic ketamine infusion (0.11 mg/kg bolus followed by 0.6 mg/kg slow-drip over 50 min)
Interventions
- Ketamine0.71 mg/kgvia IV• single dose• 1 doses total
52-min infusion (2-min bolus followed by 50 min infusion)
Lorazepam 2mg
active comparatorLorazepam infusion (saline bolus over 2 min followed by 2 mg slow-drip over 50 min)
Interventions
- Placebo2 mgvia IV• single dose• 1 doses total
52-min infusion (2-min bolus followed by 50 min infusion)
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamine 0.41mg/kgexperimental | 8 | 0(0.0%) | 0(0.0%) | 0(0.0%) | 0(0.0%) |
| Ketamine 0.71mg/kgexperimental | 8 | 0(0.0%) | 0(0.0%) | 0(0.0%) | 0(0.0%) |
| Lorazepam 2mgactive_comparator | 8 | 0(0.0%) | 0(0.0%) | 0(0.0%) | 0(0.0%) |
* The paper states that all participants tolerated study procedures without adverse events, including unexpected psychiatric disturbances and initiation of ketamine or benzodiazepine misuse.