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PreprintPublic domainmedRxiv

No Heavy Drinking Days and Percentage of Days Abstinent in a Randomized Trial of Adjunctive Ketamine for Alcohol Use Disorder: Secondary Analysis of the KARE Trial

  1. 1University of Exeter

Abstract

In the KARE trial, 96 adults with severe alcohol use disorder, abstinent following detoxification, were randomised in a 2×2 factorial design to 3 weekly infusions of ketamine (0.8 mg/kg) or saline, each combined with mindfulness-based psychological support (PS) or alcohol psychoeducation (PE). We re-expressed the trial data on endpoints acceptable to regulators and compared the most and least intensive arms. Across pooled weeks 17–24, ketamine plus PS gave 78.5% versus 57.8% days abstinent (difference, 20.7 percentage points; P = .032); adjusted for baseline, the difference at weeks 21–24 was 26.9 percentage points (P = .011). At weeks 21–24, 50.0% versus 26.1% had no heavy drinking days (P = .127). Relative reductions in heavy drinking days were 55% in KARE, against 25%, −17%, 46% and 35% reported for naltrexone, exenatide, semaglutide and pemvidutide. These post hoc differences, measured 4 to 6 months after a 4 week course ended, are of magnitude similar to agents requiring continuous administration.

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BibTeX
@misc{morgan2026heavy,
  title = {{No Heavy Drinking Days and Percentage of Days Abstinent in a Randomized Trial of Adjunctive Ketamine for Alcohol Use Disorder: Secondary Analysis of the KARE Trial}},
  author = {C. J. Morgan and D. J. Nutt},
  howpublished = {medRxiv},
  year = {2026},
  month = sep,
  doi = {10.64898/2026.09.26.26363761},
  url = {https://www.medrxiv.org/content/10.64898/2026.09.26.26363761v1},
  note = {Public domain},
}
RIS
TY  - UNPB
TI  - No Heavy Drinking Days and Percentage of Days Abstinent in a Randomized Trial of Adjunctive Ketamine for Alcohol Use Disorder: Secondary Analysis of the KARE Trial
AU  - C. J. Morgan
AU  - D. J. Nutt
PY  - 2026
DA  - 2026/09/26
PB  - medRxiv
DO  - 10.64898/2026.09.26.26363761
UR  - https://www.medrxiv.org/content/10.64898/2026.09.26.26363761v1
AB  - In the KARE trial, 96 adults with severe alcohol use disorder, abstinent following detoxification, were randomised in a 2×2 factorial design to 3 weekly infusions of ketamine (0.8 mg/kg) or saline, each combined with mindfulness-based psychological support (PS) or alcohol psychoeducation (PE). We re-expressed the trial data on endpoints acceptable to regulators and compared the most and least intensive arms. Across pooled weeks 17–24, ketamine plus PS gave 78.5% versus 57.8% days abstinent (difference, 20.7 percentage points; P = .032); adjusted for baseline, the difference at weeks 21–24 was 26.9 percentage points (P = .011). At weeks 21–24, 50.0% versus 26.1% had no heavy drinking days (P = .127). Relative reductions in heavy drinking days were 55% in KARE, against 25%, −17%, 46% and 35% reported for naltrexone, exenatide, semaglutide and pemvidutide. These post hoc differences, measured 4 to 6 months after a 4 week course ended, are of magnitude similar to agents requiring continuous administration.
ER  -