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

September 30, 2010 updated by: The University of Texas Health Science Center, Houston

Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Joy Schmitz, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Study Completion (ACTUAL)

May 1, 2003

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

November 2, 1999

First Posted (ESTIMATE)

November 3, 1999

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2010

Last Update Submitted That Met QC Criteria

September 30, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAA-SCHMITZ-11216-04
  • R01AA011216 (NIH)
  • NIH Grant 5R01AA011216-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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