The aim of the present clinical trial is to investigate whether 14 weeks of treatment with a prescription medication for smoking cessation (European trade name: Champix(R); US trade name: Chantix(R)), can reduce alcohol consumption in alcohol dependent individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
162
14 weeks of per oral tablet treatment in an escalating dosing regimen (0.5 mg - 1.0 mg/day; 1 - 2 tablets/day).
14 weeks of per oral tablet treatment in an escalating dosing regimen (1 - 2 tablets/day)
Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital
Gothenburg, Sweden
Beroendecentrum, Malmö University Hospital (UMAS), Sweden
Malmo, Sweden
Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital
Stockholm, Sweden
Alcohol consumption as measured by diary and questionnaires: the number of heavy drinking days (as percentage) defined as ≥5 standard drinks per day for men and ≥4 standard drinks per day for women
Alcohol consumption as measured by diary and questionnaires: total amount (grams) of consumed alcohol compared to baseline.
Percentage (and number) of abstaining days compared to baseline.
Drinks per drinking day compared to baseline.
Alcohol consumption as measured by alcohol markers in blood compared to baseline.
Nicotine use in alcohol dependent subjects as measured by diary and questionnaires compared to baseline.
Compliance as measured by diary and returned medication packages.
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