Naltrexone Augmentation of Nicotine Patch Therapy - 1

Completed · Phase 3

Conditions studied: Tobacco Use Disorder

In brief

Naltrexone Augmentation of Nicotine Patch Therapy

Key facts

Study ID

NCT00218153

Run by

National Institute on Drug Abuse (NIDA)

People needed

200

Starts

2000-11-01

Expected to finish

2004-04-01

Last updated by the study team

2017-01-12

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Substance Abuse Treatment Unit — New Haven, Connecticut, United States
• VA Connecticut Health Care System — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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