Alcohol dependence Nicotine dependence in alcohol dependent individuals
Conditions
Interventions
Trade Name: Champix
Product Name: CHAMPIX
Pharmaceutical Form: Coated tablet
INN or Proposed INN: varenicline tartrate
Other descriptive name: Champix
Concentration unit: mg milligram(s)
Concentration
Sponsors
Göteborg University, Sect. Psyhiatry and Neurochemistry
Göteborg University, Sect. Psychiatry and Neurochemistry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 30-70 years at screening 2) Alcohol dependence according to DSM-IV (meeting =3 out of 7 criteria) 3) = 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 4) Participants must have signed the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Subject to treatment of alcohol withdrawal within 30 days of study initiation 2) Subject to treatment that may affect alcohol consumption including acamprosate, naltrexone, disulfiram, ondansetron, topiramate, SSRIs, varenicline, mirtazepine, within 3 months of study initiation 3) Subject to treatment of depression within 3 months of study initiation 4) The continuous use of drugs such as hydroxizin, alimemazin, benzodiazepines or sedatives (the sporadic use of these compounds is accepted) 5) Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial 6) History of Delirium Tremens the last 5 years or any history of abstinence-induced seizures 7) 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. 8) 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. 9) Any ongoing serious psychiatric or somatic disorder 10) Any psychiatric Axel I diagnoses (except for nicotine or alcohol dependence) 11) The concurrent use of illicit drugs 12) The need for detoxification 13) Diabetes Mellitus Type 1 14) Suicidal risk 15) Additional factors that implies to the investigator/physician that the participant will not be completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can the oral administration of a prescription medication for smoking cessation alter alcohol consumption in alcohol dependent individuals? ;Secondary Objective: Can the oral administration of a prescription medication for smoking cessation alter nicotine consumption in alcohol dependent individuals? Can good compliance be accomplished with self-administration of an oral tablet for the treatment of alcohol dependence? ;Primary end point(s): 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, during weeks 3-12 of the active treatment period compared to baseline. | — |
Countries
Sweden
Outcome results
None listed