Active-controlled trial of a Ketamine Assisted Group Mindfulness intervention for Alcohol Use Disorder

This interventional trial (n=80) aims to investigate the effectiveness of a Ketamine Assisted Group Mindfulness intervention for Alcohol Use Disorder (AUD).

The trial, conducted at Southern District Health Board property in New Zealand, involves a six-week group mindfulness programme tailored for individuals with AUD.

Participants, aged 18 to 70, will attend weekly sessions led by trained facilitators, incorporating mindfulness education and practical activities. The study randomly assigns participants to two arms: one receiving oral doses of ketamine during weeks 3 and 5, and the other receiving an active control drug, midazolam, in conjunction with the mindfulness sessions.

The primary outcome measures the self-reported drinking days using the timeline follow-back method up to week 10 after the sixth session. Secondary outcomes include measures of alcohol craving, self-efficacy, breathalyzer screening, psychological scales, quality of life, and other assessments.

Recruitment for the trial is anticipated to start on March 1, 2022, with a target sample size of 80 participants. The trial is funded by the University of Otago and led by Dr. Charlotte Mentzel. Ethics approval is pending from the Northern B Health and Disability Ethics Committee.

The study addresses a gap in AUD treatment in New Zealand, aiming to assess ketamine’s potential as an adjunct to mindfulness therapy, particularly in culturally diverse populations like Maori or Pacifica. For further information, individuals may contact Dr. Charlotte Mentzel at [email protected].

Trial Details

This research addresses a gap in the provision of treatment for Alcohol Use Disorder (AUD) in Aotearoa New Zealand. We need to expand our toolkit for treating alcohol use disorder in a culturally appropriate manner, one which is reflective of Aotearoa’s multicultural society. Current therapies are weakly effective and exclude the world view of Maori or Pacifica people. This study aims to explore if ketamine can assist group therapy for the treatment of AUD in Aotearoa New Zealand. Therefore, the hypothesis of this study is that low dose oral ketamine will be a positive adjunct to a culturally appropriate mindfulness intervention for those with alcohol use disorder, increasing rates and length of abstinence.

NCT Number ACTRN12622000245796p

Data attribution

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