None listed
Conditions
Brief summary
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.
Interventions
This is a clinical trial exploring the usefulness of a mindfulness intervention assisted by ketamine for the purpose of reducing alcohol intake in people with alcohol use disorder.
All participants will receive six weeks of a group mindfulness programme. This mindfulness programme has been designed specifically for this study. The programme is accessible for people who participating in this study. The group mindfulness programme will be held in person in study clinic space at Southern District
This is a clinical trial exploring the usefulness of a mindfulness intervention assisted by ketamine for the purpose of reducing alcohol intake in people with alcohol use disorder. All participants will receive six weeks of a group mindfulness programme. This mindfulness programme has been designed specifically for this study. The programme is accessible for people who participating in this study. The group mindfulness programme will be held in person in study clinic space at Southern District Health Board property, NZ. The mindfulness sessions will be delivered by 2 trained facilitators for each session. Each participant will have one session a week for 6 weeks. Sessions will last approximately 3 hours. Each of the 6 sessions follow a manualized program of mindfulness education and practical activities. An example of an education activity is learning about the value of mindfulness to 'urge surf' cravings, and an example of a practical activities is working through a meditation to centre the breath. In-person groups will be limited to no more than 10 participants per session. Participants will be randomly divided into two arms. Arm one will receive doses of ketamine in weeks 3 and 5 of the mindfulness intervention. Arm two will receive doses of active control drug midazolam in weeks 3 and 5 of the mindfulness intervention. These drugs will be administered as part of the mindfulness sessions. The ketamine will be administered as an oral dose of 1.5mg per kg of bodyweight. The ketamine will be given orally as a solution, in juice. The intervention administration will take place on District Health Board (DHB) property to facilitate access to appropriate safety measures. Participant’s alcohol use will be monitored through breathalyser at each mindfulness session. Additionally, long term alcohol use will be measured through a blood test. The standard of ’timeline followbacks’, essentially an alcohol use diary, will also be used.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Capable of understanding and signing an informed consent Aged 18 years and over, and under 70 years old on the day of consent Have an established diagnosis of moderate to severe AUD
Exclusion criteria
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.
Outcome results
None listed