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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Completed

CT.gov ID

NCT00000447

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

200

Enrollment

Location

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism Smoking	Drug: naltrexone (Revia) Drug: nicotine replacement patch	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence

Study Start Date :

Sep 1, 1998

Actual Study Completion Date :

May 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00000447

Other Study ID Numbers:

NIAAA-SCHMITZ-11216-04
R01AA011216
NIH Grant 5R01AA011216-04

First Posted:

Nov 3, 1999

Last Update Posted:

Oct 1, 2010

Last Verified:

Sep 1, 2010

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2010