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

NCT00000447 | Completed Phase 4

• 3 other identifiers: NIAAA-SCHMITZ-11216-04R01AA011216NIH Grant 5R01AA011216-04
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism; Smoking

Interventions

naltrexone (Revia) DRUG

nicotine replacement patch DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Alcoholism; Smoking

Interventions

Naltrexone; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Therapeutics

Study Officials

• Joy Schmitz

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: September 1, 1998
• Study Completion: May 1, 2003
• Last Updated: October 1, 2010

Record last verified: 2010-09

Locations

US (1)