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

Houston, Texas, United States, 77030

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