Status:
COMPLETED
Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Smoking
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
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 ...
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.
Key Trial Info
Start Date :
September 1 1998
Trial Type :
INTERVENTIONAL
End Date :
May 1 2003
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00000447
Start Date
September 1 1998
End Date
May 1 2003
Last Update
October 1 2010
Active Locations (1)
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1
Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center
Houston, Texas, United States, 77030