Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-26

Study Completion Date

2005-09-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alcoholism Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind tablet and patch active study medications, and matched tablet and patch placebos

Study Groups

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Naltrexone Tablet and Nicotine Patch

Group Type EXPERIMENTAL

Naltrexone Tablet and Nicotine Patch

Intervention Type DRUG

Naltrexone Tablet and Placebo Patch

Group Type ACTIVE_COMPARATOR

Naltrexone Tablet and Placebo Patch

Intervention Type DRUG

Placebo Tablet and Nicotine Patch

Group Type ACTIVE_COMPARATOR

Placebo Tablet and Nicotine Patch

Intervention Type DRUG

Placebo Tablet and Placebo Patch

Group Type PLACEBO_COMPARATOR

Placebo Tablet and Placebo Patch

Intervention Type DRUG

Interventions

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Naltrexone Tablet and Nicotine Patch

Intervention Type DRUG

Naltrexone Tablet and Placebo Patch

Intervention Type DRUG

Placebo Tablet and Nicotine Patch

Intervention Type DRUG

Placebo Tablet and Placebo Patch

Intervention Type DRUG

Other Intervention Names

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Revia and Nicotrol Revia Nicotrol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No