Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

The Scripps Research Institute

Status and phase: Completed; Phase 4

Conditions: Alcoholism; Smoking

Treatments: Drug: Placebo Tablet and Nicotine Patch; Drug: Naltrexone Tablet and Nicotine Patch; Drug: Placebo Tablet and Placebo Patch; Drug: Naltrexone Tablet and Placebo Patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000437

NIAAAMAS11210

R01AA011210 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Naltrexone Tablet and Nicotine Patch

Experimental group

Treatment:

Drug: Naltrexone Tablet and Nicotine Patch

Naltrexone Tablet and Placebo Patch

Active Comparator group

Treatment:

Drug: Naltrexone Tablet and Placebo Patch

Placebo Tablet and Nicotine Patch

Active Comparator group

Treatment:

Drug: Placebo Tablet and Nicotine Patch

Placebo Tablet and Placebo Patch

Placebo Comparator group

Treatment:

Drug: Placebo Tablet and Placebo Patch