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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcoholism Alcohol-Related Disorders Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

naltrexone (Revia)

Drug

nicotine replacement patch

Drug

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence

Important dates

Study start: 1998
Study completion: 2003
First posted: Nov 3, 1999
Registry last updated: Oct 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed