The Effect of Brief Potent Glutamatergic Modulation on Cocaine Dependence
This project will evaluate the effect of a single sub-anesthetic dose of ketamine on the time to first cocaine use and abstinence rates in 60 treatment-seeking cocaine-dependent individuals receiving mindfulness-based relapse prevention (MBRP) therapy, using a 5 week combined laboratory-inpatient and outpatient double-blind, randomized, controlled trial.
Study Arms & Interventions
Ketamine
experimentalA single 40-minute intravenous infusion of ketamine (0.5 mg/kg) combined with a 5-week course of mindfulness-based relapse prevention (MBRP).
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
40-minute slow-drip infusion; combined with MBRP
Midazolam
active comparatorA single 40-minute intravenous infusion of midazolam (0.025 mg/kg) combined with a 5-week course of mindfulness-based relapse prevention (MBRP).
Interventions
- Placebo0.025 mg/kgvia IV• single dose• 1 doses total
40-minute slow-drip infusion; used as active control; combined with MBRP
Primary Results(1 publication)
Participants
Response Rates
urine-test-confirmed abstinence over the last 2 weeks of the trial
no relapse (did not use cocaine or drop out)
reported abstinence
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamineexperimental | 27 | — | — | 0(0.0%) | 7(25.9%) |
| Midazolamactive_comparator | 28 | 7(25.0%) | — | 0(0.0%) | 16(57.1%) |
* The paper states 'Infusions were well tolerated' and 'no participants were removed from the study as a result of adverse events'. Discontinuation count (7) is from the CONSORT diagram (Discontinued/lost contact).
* The only reported adverse effect was mild sedation (7 participants). Discontinuation count (16) is from the CONSORT diagram (Discontinued/lost contact).