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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

December 6, 2007

Start Date ^ICMJE

September 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000447 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Alcoholism
Smoking

Intervention ^ICMJE

Drug: naltrexone (Revia)
Drug: nicotine replacement patch

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

May 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000447

Responsible Party

Study ID Numbers ^ICMJE

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

Study Sponsor ^ICMJE

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Joy Schmitz

The University of Texas Health Science Center, Houston

Information Provided By

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP