Naltrexone Augmentation of Nicotine Patch Therapy - 1

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: NCT00218153
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

September 16, 2005
September 22, 2005
January 12, 2017
November 2000
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Complete list of historical versions of study NCT00218153 on Archive Site
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Naltrexone Augmentation of Nicotine Patch Therapy - 1
Naltrexone Augmentation of Nicotine Patch Therapy
Naltrexone Augmentation of Nicotine Patch Therapy
This double blind placebo controlled study is designed to determine whether naltrexone can be used to help reduce cigarette use and craving for cigarettes. Eligible participants will receive 21mg transdermal nicotine as an outpatient. In addition, participants will receive one of three doses of naltrexone (25,50 or 100mg) or a placebo and brief counseling over the course of six weeks with follow-up appointments three, six, and twelve months after the beginning of treatment.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Tobacco Use Disorder
Drug: Naltrexone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2004
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Inclusion Criteria:

  1. Age 18 and older
  2. Willingness and ability to give written consent
  3. Smoking 20 cigarettes per day for at least 1 year
  4. At least one prior attempt to stop smoking
  5. Baseline expired carbon-monoxide level of at least 10 ppm
  6. Weigh at least 100 lbs.
  7. English speaking
  8. One person per household

Exclusion Criteria:

  1. Pregnant or nursing women or women who do not use a reliable form of birth control
  2. Unstable cardiac disease
  3. History of dermatoses
  4. Current alcohol dependence
  5. Current use of opiates
  6. A urine drug screen that is positive for opiates
  7. Serious current neurologic, psychiatric or medical illness
  8. Chronic pain conditions necessitating opioid treatment
  9. Evidence of significant hepatocellular injury as evidence by SGOT or SGPT >3 x normal or elevated bilirubin
  10. Current use of smokeless tobacco, pipes, cigars, nicotine gum or nicotine patch
  11. Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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National Institute on Drug Abuse (NIDA)
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Principal Investigator: Stephanie O'Malley, Ph.D. Substance Abuse Treatment Unit
National Institute on Drug Abuse (NIDA)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP