Ketamine for Reduction of Alcoholic Relapse
Summary
96 recently detoxified alcoholics will be randomized to receive either 3 sessions ketamine (0.8 mg/kg IV over 45 minutes) or placebo plus manualised psychological therapy, or 3 sessions of ketamine or placebo plus simple psychoeducation. Patients will be assessed at 3 and 6 months on a range of psychological and biological variables. Primary endpoints will be % days abstinent at 6 months and relapse rates at 6 months. Secondary endpoints include depressive symptoms, craving, quality of life.
Timeline
- Start
- 2016-10
- Primary completion
- 2020-02
- Completion
- 2020-02
Outcome
Mixed primary results
paper There was no significant difference in relapse rate between the ketamine and placebo groups. PMID 35012326 ↗
registry Odds Ratio (OR) 0.7 (95% CI 0.28 to 1.75) NCT02649231 ↗
paper there were a significantly greater number of days abstinent from alcohol in the ketamine group compared with the placebo group PMID 35012326 ↗
registry Mean Difference (Final Values) 10.1 (95% CI 1.1 to 19.0) NCT02649231 ↗
Publications
- Grabski M, McAndrew A, Lawn W, Marsh B, Raymen L, Stevens T, Hardy L, Warren F, Bloomfield M, Borissova A, Maschauer E, Broomby R, Price R, Coathup R, Gilhooly D, Palmer E, Gordon-Williams R, Hill R, Harris J, Mollaahmetoglu OM, Curran HV, Brandner B, Lingford-Hughes A, Morgan CJA. Adjunctive Ketamine With Relapse Prevention-Based Psychological Therapy in the Treatment of Alcohol Use Disorder. Am J Psychiatry. 2022 Feb;179(2):152-162. doi: 10.1176/appi.ajp.2021.21030277. Epub 2022 Jan 11.
- Grabski M, Borissova A, Marsh B, Morgan CJA, Curran HV. Ketamine as a mental health treatment: Are acute psychoactive effects associated with outcomes? A systematic review. Behav Brain Res. 2020 Aug 17;392:112629. doi: 10.1016/j.bbr.2020.112629. Epub 2020 May 30.
- McAndrew A, Lawn W, Stevens T, Porffy L, Brandner B, Morgan CJ. A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial. Trials. 2017 Apr 4;18(1):159. doi: 10.1186/s13063-017-1895-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 0.8 mg/kg | Intravenous |