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NCT00218153 Clinical Trial

Naltrexone Augmentation of Nicotine Patch Therapy - 1

Tobacco Use Disorder Clinical Trial

Official title:
Naltrexone Augmentation of Nicotine Patch Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00218153
Other study ID # NIDA-13334-1
Secondary ID P50-13334-1
Status Completed
Phase Phase 3
First received September 16, 2005
Last updated January 11, 2017
Start date November 2000
Est. completion date April 2004

Study information
Verified date September 2005
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Naltrexone Augmentation of Nicotine Patch Therapy

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Naltrexone

Locations
Country Name City State
United States Substance Abuse Treatment Unit New Haven Connecticut
United States VA Connecticut Health Care System New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

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