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

Smoking Clinical Trial

Official title:

Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000447
• Other study ID #: NIAAA-SCHMITZ-11216-04
• Secondary ID: R01AA011216NIH G
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: September 30, 2010
• Start date: September 1998
• Est. completion date: May 2003

Study information

• Verified date: September 2010
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Smoking

Intervention

Drug:
• naltrexone (Revia)

• nicotine replacement patch

Locations

Country	Name	City	State
United States	Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,