Naltrexone in Tobacco Use Disorder - Clinical Trials Registry

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Stephanie O'Malley, Ph.D., Substance Abuse Treatment Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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