Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2003-05-31

Brief Summary

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This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.

Detailed Description

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Conditions

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Alcoholism Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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naltrexone (Revia)

Intervention Type DRUG

nicotine replacement patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets criteria for alcohol and nicotine dependence.
* Individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours.
* Smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day.
* Motivated to quit smoking.
* Willing and able to participate in the 12 week outpatient treatment.
* Acceptable health.
* Able to provide a collateral informant.
* Willing to be followed for 6 months after treatment ends.
* Willing and able to provide the names of three family members or friends to aid in locating participants for follow-up.

Exclusion Criteria

* Current diagnosis of dependence on other substances except nicotine and alcohol.
* Having moderately severe or severe alcohol withdrawal symptoms.
* Recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males).
* History of opioid abuse.
* Recent use of cocaine.
* Not desiring to quit smoking.
* Recent past or current pharmacotherapy involving naltrexone or transdermal nicotine systems.
* History of psychosis.
* Current suicidality, homicidally or psychiatric symptoms requiring other medications.
* Presence of medical abnormalities that contraindicate naltrexone or nicotine replacement therapy.
* Current treatment with psychotropic medications.
* Pregnancy or nursing for female patients. Inability or unwillingness to participate in the 12-week outpatient treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Joy Schmitz

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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R01AA011216

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH Grant 5R01AA011216-04

Identifier Type: -