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Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (naltrexone/nicotine patch) - Article


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Naltrexone

ReVia



Clinical Trial: Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (naltrexone/nicotine patch)

This study is no longer recruiting patients.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

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 Treatment or Intervention Phase
Alcoholism
Smoking
 Drug: naltrexone (Revia)
 Drug: nicotine replacement patch
Phase IV

MedlinePlus related topics:  Alcoholism;   Smoking

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Official Title: Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence

Further Study Details: 

Expected Total Enrollment:  200

Study completion: June 2003

Eligibility

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Both

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.

Location Information


Texas
      Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center, Houston,  Texas,  77030,  United States

More Information

Study ID Numbers:  NIAAASCH11216
Record last reviewed:  November 2004
Last Updated:  November 22, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000447
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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November 18, 2008



Page Updated: June 1, 2005
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