Clinical TrialAlcohol Use Disorder (AUD)KetamineMidalozamNot yet recruiting

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

This randomised controlled parallel group Phase II trial (n=80) evaluated the safety and efficacy of ketamine for alcohol use disorder.

Target Enrollment
80 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

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.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine
  • Midalozam

Participants

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.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment80 participants
  • Timeline
    Start: 2022-03-01
    End: 2022-09-01
  • Compounds
    KetamineMidalozam
  • Topic
    Alcohol Use Disorder (AUD)

Locations

Unknown facility — Australia

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