Examining a unique medication for alcoholic smokers

Completed

• Conditions: Alcohol dependence; nicotine dependence; Mental and Behavioural Disorders; Alcohol and nicotine dependence

• Registration Number: ISRCTN62137064
• Lead Sponsor: ABMRF/The Foundation for Alcohol Research (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified