Naltrexone Augmentation of Nicotine Patch Therapy - 1

Naltrexone Augmentation of Nicotine Patch Therapy

Naltrexone Augmentation of Nicotine Patch Therapy

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Naltrexone

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 Type: Interventional
• Enrollment: 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • VA Connecticut Health Care System
    • New Haven, Connecticut, United States, 06519
      • Substance Abuse Treatment Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Stephanie O'Malley, Ph.D., Substance Abuse Treatment Unit

Publications and helpful links

General Publications

• King AC, Cao D, Zhang L, O'Malley SS. Naltrexone reduction of long-term smoking cessation weight gain in women but not men: a randomized controlled trial. Biol Psychiatry. 2013 May 1;73(9):924-30. doi: 10.1016/j.biopsych.2012.09.025. Epub 2012 Nov 22.
• O'Malley SS, Krishnan-Sarin S, McKee SA, Leeman RF, Cooney NL, Meandzija B, Wu R, Makuch RW. Dose-dependent reduction of hazardous alcohol use in a placebo-controlled trial of naltrexone for smoking cessation. Int J Neuropsychopharmacol. 2009 Jun;12(5):589-97. doi: 10.1017/S146114570800936X. Epub 2008 Sep 17.

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Study Completion: April 1, 2004

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: nicotine dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: NIDA-13334-1; P50-13334-1