Naltrexone Augmentation of Nicotine Patch Therapy - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218153
First received: September 16, 2005
Last updated: November 3, 2005
Last verified: September 2005
  Purpose

Naltrexone Augmentation of Nicotine Patch Therapy


Condition Intervention Phase
Tobacco Use Disorder
Drug: Naltrexone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Naltrexone Augmentation of Nicotine Patch Therapy

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Estimated Enrollment: 200
Study Start Date: November 2000
Estimated Study Completion Date: April 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218153

Locations
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
Investigators
Principal Investigator: Stephanie O'Malley, Ph.D. Substance Abuse Treatment Unit
  More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional 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, P50-13334-1
Study First Received: September 16, 2005
Last Updated: November 3, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Naltrexone
Nicotine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Ganglionic Stimulants
Autonomic Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014