Status:
COMPLETED
Naltrexone Augmentation of Nicotine Patch Therapy - 1
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
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 tran...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00218153
Start Date
November 1 2000
End Date
April 1 2004
Last Update
January 12 2017
Active Locations (2)
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1
Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06519
2
VA Connecticut Health Care System
New Haven, Connecticut, United States, 06519