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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000447
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : October 1, 2010
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Alcoholism Smoking Drug: naltrexone (Revia) Drug: nicotine replacement patch Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence
Study Start Date : September 1998
Actual Study Completion Date : May 2003

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000447

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United States, Texas
Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Principal Investigator: Joy Schmitz The University of Texas Health Science Center, Houston

Layout table for additonal information Identifier: NCT00000447     History of Changes
Other Study ID Numbers: NIAAA-SCHMITZ-11216-04
R01AA011216 ( U.S. NIH Grant/Contract )
NIH Grant 5R01AA011216-04
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: October 1, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Tobacco Use Disorder
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Alcohol Deterrents
Narcotic Antagonists
Sensory System Agents