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Naltrexone Augmentation of Nicotine Patch Therapy - 1

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ClinicalTrials.gov Identifier: NCT00218153
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
Information provided by:

Study Description
Brief Summary:
Naltrexone Augmentation of Nicotine Patch Therapy

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Naltrexone Phase 3

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Naltrexone Augmentation of Nicotine Patch Therapy
Study Start Date : November 2000
Estimated Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00218153

United States, Connecticut
Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06519
VA Connecticut Health Care System
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Stephanie O'Malley, Ph.D. Substance Abuse Treatment Unit
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00218153     History of Changes
Other Study ID Numbers: NIDA-13334-1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: September 2005

Keywords provided by National Institute on Drug Abuse (NIDA):
nicotine dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
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
Narcotic Antagonists
Sensory System Agents