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

Primary Purpose

Alcoholism, Smoking

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
naltrexone (Revia)
nicotine replacement patch
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
September 30, 2010
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000447
Brief Title
Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)
Official Title
Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
naltrexone (Revia)
Intervention Type
Drug
Intervention Name(s)
nicotine replacement patch

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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. Current treatment with psychotropic medications. Pregnancy or nursing for female patients. Inability or unwillingness to participate in the 12-week outpatient treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy Schmitz
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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