Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Study Overview
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Brief Summary
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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.

Official Title
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Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: varenicline (Champix/Chantix)
* Drug: placebo for varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 30-70 years at screening Alcohol dependence according to DSM-IV (meeting ≥3 out of 7 criteria) ≥ 20 heavy drinking days (men: ≥ 5 drinks/day, women: ≥4 drinks/day, where 1 std. drink is defined as 12 g ethanol) during the last 60 days Participants must have signed the informed consent Exclusion Criteria: Subject to treatment of alcohol withdrawal within 30 days of study initiation Subject to treatment that may affect alcohol consumption including acamprosate, naltrexone, disulfiram, ondansetron, topiramate, SSRIs, varenicline, mirtazapine, rimonabant, methylphenidate or atomoxetine within 3 months of study initiation Subject to treatment of depression within 3 months of study initiation The continuous use of drugs such as codeine, hydroxyzine, alimemazine, benzodiazepines or sedatives (the sporadic use of these compounds is accepted) Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial History of Delirium Tremens the last 5 years or any history of abstinence-induced seizures Laboratory hepatic values of more than 3 times the upper limit of the normal range or other clinically significant abnormalities in the screening laboratory values. Participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective. Any ongoing serious psychiatric or somatic disorder Any psychiatric Axel I diagnoses (except for nicotine or alcohol dependence) The concurrent use of illicit drugs based on urine-toxicity test The need for detoxification Diabetes Mellitus Type 1 Suicidal risk Homelessness Additional factors that implies to the investigator/physician that the participant will not be completing the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: varenicline<br> | Drug: varenicline (Champix/Chantix)<br>* 14 weeks of per oral tablet treatment in an escalating dosing regimen (0.5 mg - 1.0 mg/day; 1 - 2 tablets/day).<br>* Other names: Champix(R)/Chantix(R);|
| Placebo Comparator: placebo<br> | Drug: placebo for varenicline<br>* 14 weeks of per oral tablet treatment in an escalating dosing regimen (1 - 2 tablets/day)<br>* Other names: placebo for Champix(R) / Chantix(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol dependence, nicotine dependence, alcohol abuse, varenicline, Champix, Chantix, smoking, drinking, snuffing, diary, phosphatidyl ethanol, PEth