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Trial registered on ANZCTR


Registration number
ACTRN12622000245796p
Ethics application status
Submitted, not yet approved
Date submitted
13/01/2022
Date registered
10/02/2022
Date last updated
10/02/2022
Date data sharing statement initially provided
10/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Ketamine assisted group mindfulness for alcohol use disorder
Scientific title
Active-controlled trial of a Ketamine Assisted Group Mindfulness intervention for Alcohol Use Disorder
Secondary ID [1] 305939 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder 324535 0
Condition category
Condition code
Mental Health 322002 322002 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322331 0
Treatment: Drugs
Comparator / control treatment
Midazolam will be used as an active control drug will be used in this study. 0.05mg/kg of midazolam, given orally in 50mL orange juice.
Control group
Active

Outcomes
Primary outcome [1] 329758 0
Self-reported drinking days by timeline follow-back after ketamine/midazolam dosing out to week 10. This will be dichotomized so that each day is defined as abstinent (0 drinks) or non-abstinent (at least one drink). Days with missing data will be treated as non-abstinent days.
Timepoint [1] 329758 0
Measure the first four weeks after the sixth session of mindfulness.
Secondary outcome [1] 403672 0
Alcohol craving (using a Visual Analogue Scale)
Timepoint [1] 403672 0
Completed at screen, in weeks one through to week 4 and then week 6 (final) of mindfulness programme, and at week 10 follow up.
Follow up phone calls at 3 and 6 months after the sixth (final) session.
Secondary outcome [2] 405872 0
Self-efficacy - assessed with the Alcohol Abstinence Self-Efficacy Scale
Timepoint [2] 405872 0
Completed at screen, in weeks one through to week 4 and then week 6 (final) of mindfulness programme, and at week 10 follow up.
Follow up phone calls at 3 and 6 months after the sixth (final) session.
Secondary outcome [3] 405873 0
Breathalyzer screening for alcohol use
Timepoint [3] 405873 0
Completed at screen, in weeks one through to week 6 (final) of mindfulness programme, and at week 10 follow up.
Secondary outcome [4] 405874 0
Hamilton Anxiety and Depression Scale (HADS)
Timepoint [4] 405874 0
Completed at screen, week 6 (final) of mindfulness programme, and at week 10 follow up.
Secondary outcome [5] 405875 0
Dropout rates measured through study attendance (participants coming to mindfulness programme session and follow up appointments, completion of study surveys).
Timepoint [5] 405875 0
Considered after a participant has been screened and included in study, until completion.
Secondary outcome [6] 405876 0
World Health Organisation Quality of Life – BREF (WHOQOL-BREF)
Timepoint [6] 405876 0
Completed at screen, week 6 (final) of mindfulness programme, and at week 10 follow up.
Secondary outcome [7] 405877 0
Watts Connectedness Scale (WCS)
Timepoint [7] 405877 0
Completed at screen, week 6 (final) of mindfulness programme, and at week 10 follow up.
Secondary outcome [8] 405878 0
Psychological Insight Questionnaire (PIQ)
Timepoint [8] 405878 0
Completed at (final) week 6 of mindfulness (MTM)
Secondary outcome [9] 405883 0
Carbohydrate deficient transferrin (CDT) blood test as a measure for long term alcohol use
Timepoint [9] 405883 0
Measure at screen and at follow up in week 10 (week number is based on the participants's first mindfulness session).
Secondary outcome [10] 405884 0
Columbia Suicide Severity Rating (CSSR)
Timepoint [10] 405884 0
Administered at screen, and then in week 6 (final) mindfulness session. Again at week 10 follow up.
Secondary outcome [11] 405885 0
Clinician Administered Dissociative Symptoms Scale (CADSS)
Timepoint [11] 405885 0
Administered at screen, then in weeks 3 and 5 of the mindfulness programme alongside ketamine or midazolam intervention

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done by block randomisation. Numbered containers will be used for administration of oral doses of both intervention and control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
All participants will participate in a group mindfulness intervention. Participants will be randomised to receive either the ketamine intervention or active control drug midazolam.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant demographic, background characteristics and trial data will be descriptively summarized for all participants. A survival analysis will be performed to compare the days till relapse in the placebo and ketamine group with the primary endpoint being number of days until relapse of alcohol.

Outcomes of rating scales measures such as depression, quality of life will be compared between groups, the test used will be dependent on whether the variation follows a normal distribution or a non-normal distribution. In the first case a student's t-test will be used, in the second a Mann Whitney U test will be used. Results from the PIQ and the WCS will be summarised and compared between the two groups, overall scale results will be compared using an ANOVA. The primary goal of this is to guide the details of future psychological interventions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
1/09/2022
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 24359 0
New Zealand
State/province [1] 24359 0
Otepoti/Dunedin

Funding & Sponsors
Funding source category [1] 310278 0
University
Name [1] 310278 0
University of Otago
Country [1] 310278 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Psychological Medicine
Otago University Medical School
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 311386 0
None
Name [1] 311386 0
Address [1] 311386 0
Country [1] 311386 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309949 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 309949 0
Ethics committee country [1] 309949 0
New Zealand
Date submitted for ethics approval [1] 309949 0
21/12/2021
Approval date [1] 309949 0
Ethics approval number [1] 309949 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115954 0
Dr Charlotte Mentzel
Address 115954 0
Department of Psychological Medicine
Otago Medical School
PO Box 56
Dunedin 9054
New Zealand
Country 115954 0
New Zealand
Phone 115954 0
+64 03 470 9451
Fax 115954 0
Email 115954 0
audket@otago.ac.nz
Contact person for public queries
Name 115955 0
Charlotte Mentzel
Address 115955 0
Department of Psychological Medicine
Otago Medical School
PO Box 56
Dunedin 9054
New Zealand
Country 115955 0
New Zealand
Phone 115955 0
+64 03 470 9451
Fax 115955 0
Email 115955 0
audket@otago.ac.nz
Contact person for scientific queries
Name 115956 0
Charlotte Mentzel
Address 115956 0
Department of Psychological Medicine
Otago Medical School
PO Box 56
Dunedin 9054
New Zealand
Country 115956 0
New Zealand
Phone 115956 0
+64 03 470 9451
Fax 115956 0
Email 115956 0
audket@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy
Ethics requirement for no Maori data to leave the country, it must be stored on NZ servers.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.