Last updated: March 14, 2023
Sponsor: University of Sydney
Overall Status: Active - Recruiting
Phase
4
Condition
Alcohol Dependence
Alcohol Use Disorder
Substance Abuse
Treatment
N/AClinical Study ID
NCT05408247
X21-0342
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Alcohol Use Disorder according to the DSM-V criteria
- A desire to reduce or stop drinking
- Consumed at least 21 standard drinks per week or 2 heavy drinking days per week (HDD: ≥ 5 standard drinks/day for men; ≥4 for women) in the month prior to screening
- Adequate cognition and English language skills to give valid consent and completeresearch interviews
- Stable housing
- Willingness to give written informed consent
Exclusion
Exclusion Criteria:
- Pregnancy or lactation (women will be advised to use reliable contraception during thetrial and a pregnancy test will be performed were necessary)
- Concurrent use of any psychotropic medication other than antidepressants (providedthese are taken at stable doses for at least two months)
- Any substance dependence other than nicotine
- Clinically unstable systemic medical (e.g. cancer, end stage liver disease: e.g. MELDscore ≥ 10) or psychiatric disorder (e.g. active psychosis, borderline personalitydisorder, active suicide risk: e.g. MADRAS item 10 score of 6) that precludes trialparticipation
- Concurrent use of selenium, vitamin D or other anti-oxidants
- Any alcohol pharmacotherapy within the past month
Study Design
Total Participants: 280
Study Start date:
February 16, 2023
Estimated Completion Date:
November 30, 2026
Study Description
Connect with a study center
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales 2050
AustraliaActive - Recruiting
Cornwall Street Medical Centre (UQ Health Care)
Annerley, Queensland 4103
AustraliaSite Not Available
Turning Point
Richmond, Victoria 3121
AustraliaSite Not Available
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