Active-controlled trial of a Ketamine Assisted... — Clinical 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.

Female participants who are or intend to become pregnant or are lactating.
Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them.
Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
Participants who are starting new antidepressants, anxiolytics or psychotherapy within four weeks of enrolment. Use of antidepressants, anxiolytics at stable doses > four weeks prior or psychotherapy is acceptable.
Active suicidal ideation as operationalise by a CSSR score of four or higher.
Participants with comorbid schizophrenia or bipolar disorder. Depression and anxiety is acceptable.
Participants with current other moderate to severe substance use disorder other than nicotine or caffeine.
Participants with severe personality disorders as judged elevated risk by the investigator.
Participants who are on parole.

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

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