Alcoholism, Smoking
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.
Detailed description
Eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.
Interventions
DRUGNaltrexone Tablet and Nicotine Patch
DRUGNaltrexone Tablet and Placebo Patch
DRUGPlacebo Tablet and Nicotine Patch
DRUGPlacebo Tablet and Placebo Patch
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The Scripps Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind tablet and patch active study medications, and matched tablet and patch placebos
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meets criteria for alcohol dependence and nicotine dependence. * Expresses a desire to cut down or stop drinking and smoking.
Exclusion criteria
* Currently meets criteria for dependence on substances other than alcohol and nicotine. * Any history of opiate dependence or evidence of current opiate use. * Significant medical disorders that will increase potential risk or interfere with study participation. * Liver function tests more than 3 times normal or elevated bilirubin. * Females who are pregnant, nursing, or not using a reliable method of birth control. * Meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy. * Inability to understand and/or comply with the provisions of the protocol and consent form. * Treatment with an investigational drug during the previous month. * Chronic treatment with any narcotic-containing medications during the previous month. * Sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists. * Current treatment with disulfiram (Antabuse) or nicotine replacement therapy. * More than 6 weeks of abstinence.
Countries
United States
Outcome results
None listed