Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence

The University of Texas Health Science Center, Houston1 site in 1 country200 target enrollmentSeptember 1998

ConditionsAlcoholism Smoking

Drugsnaltrexone (Revia)nicotine replacement patch

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Alcoholism
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 200
Locations: 1
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 1998

End Date

May 2003

Last Updated

15 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.