Alcohol dependence
Conditions
Interventions
Baclofen 80mg/day (20 mg q.i.d.) versus placebo (contains riboflavin 25mg per each capsule as a marker of compliance and microcrystalline cellulose as filler).
Oral administration, 12-week treatment,
Sponsors
ABMRF/The Foundation for Alcohol Research (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Between 18 and 75 years old 2. DSM-IV diagnoses of both alcohol and nicotine co-dependency, with heavy use of alcohol (men = 5 Standard Drink Units [SDUs], and women = 4 SDUs a day) and cigarettes (=10 cigarettes per day) on average during the last 90 days before screening 3. Interested in receiving treatment for both drinking and smoking (either reducing or stopping both substances; or reducing one substance and stopping the other).
Exclusion criteria
Exclusion criteria: 1. Current (i.e. past year) DSM-IV diagnosis of dependence on any psychoactive substance other than alcohol and nicotine 2. Lifetime DSM-IV diagnosis of schizophrenia, bipolar disorder, or other psychosis 3. Past year diagnosis of major depression, anxiety disorders, eating disorders 4. Risk of suicide (e.g. active plan, or recent attempt in last year) 5. Positive urine drug screen at baseline for any illegal substance other than marijuana 6. Important alcohol withdrawal symptoms, as assessed by a Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score >10 7. History of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure 8. Participation in any research study for alcoholism and/or smoking treatment within 3 months prior to signing the consent document 9. Pharmacological treatment with naltrexone, acamprosate, topiramate, disulfiram, nicotine replacement, bupropion, varenicline within 1 month prior to randomization 10. Current use of psychotropic medications or medications that interfere with the metabolism of BACL, history of allergy to BACL or medical contraindications to take BACL 11. Severe medical diseases, such as cancer, cirrhosis, chronic kidney failure, chronic neurological disorders 12. Females who were of child bearing potential and not practicing effective birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percent (%) days abstinent from alcohol-tobacco co-use 2. Percent (%) days of alcohol-tobacco co-use | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Length of abstinence from alcohol 2. Length of abstinence from smoking 3. Craving for alcohol measured using Alcohol Urge Questionnaire (AUQ) and the Obsessive Compulsive Drinking Scale (OCDS) at screening (week 00), baseline/randomization day (week 01), during the intervention (weeks 02, 03, 04, 06, 08, 10, 12) and the follow-up (week 16). 4. Craving for smoking measured using Questionnaire on Smoking Urges-Brief (QSU-B) and a smoking Visual Analogue Scale (S-VAS) at screening (week 00), baseline/randomization day (week 01), during the intervention (weeks 02, 03, 04, 06, 08, 10, 12) and the follow-up (week 16). | — |
Countries
United States of America
Outcome results
None listed