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Naltrexone Augmentation of Nicotine Patch Therapy - 1

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring nicotine dependence

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 and older Willingness and ability to give written consent Smoking 20 cigarettes per day for at least 1 year At least one prior attempt to stop smoking Baseline expired carbon-monoxide level of at least 10 ppm Weigh at least 100 lbs. English speaking One person per household Exclusion Criteria: Pregnant or nursing women or women who do not use a reliable form of birth control Unstable cardiac disease History of dermatoses Current alcohol dependence Current use of opiates A urine drug screen that is positive for opiates Serious current neurologic, psychiatric or medical illness Chronic pain conditions necessitating opioid treatment Evidence of significant hepatocellular injury as evidence by SGOT or SGPT >3 x normal or elevated bilirubin Current use of smokeless tobacco, pipes, cigars, nicotine gum or nicotine patch Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component

Sites / Locations

  • Substance Abuse Treatment Unit
  • VA Connecticut Health Care System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218153
Brief Title
Naltrexone Augmentation of Nicotine Patch Therapy - 1
Official Title
Naltrexone Augmentation of Nicotine Patch Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary
Naltrexone Augmentation of Nicotine Patch Therapy
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
nicotine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Naltrexone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 and older Willingness and ability to give written consent Smoking 20 cigarettes per day for at least 1 year At least one prior attempt to stop smoking Baseline expired carbon-monoxide level of at least 10 ppm Weigh at least 100 lbs. English speaking One person per household Exclusion Criteria: Pregnant or nursing women or women who do not use a reliable form of birth control Unstable cardiac disease History of dermatoses Current alcohol dependence Current use of opiates A urine drug screen that is positive for opiates Serious current neurologic, psychiatric or medical illness Chronic pain conditions necessitating opioid treatment Evidence of significant hepatocellular injury as evidence by SGOT or SGPT >3 x normal or elevated bilirubin Current use of smokeless tobacco, pipes, cigars, nicotine gum or nicotine patch Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie O'Malley, Ph.D.
Organizational Affiliation
Substance Abuse Treatment Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Abuse Treatment Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
VA Connecticut Health Care System
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23177384
Citation
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.
Results Reference
derived
PubMed Identifier
18796184
Citation
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.
Results Reference
derived

Learn more about this trial

Naltrexone Augmentation of Nicotine Patch Therapy - 1

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