Naltrexone Augmentation of Nicotine Patch Therapy - 1

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Tobacco Use Disorder

Treatments: Drug: Naltrexone

Study type: Interventional

Funder types: NIH

Identifiers

NCT00218153

NIDA-13334-1

P50-13334-1

Details and patient eligibility

About

Naltrexone Augmentation of Nicotine Patch Therapy

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind