Effectiveness of Using Reduced Nicotine Cigarettes in Men and Women Smokers to Combat Nicotine Addiction

Completed

Conditions studied: Nicotine Dependence, Tobacco Use Disorder

In brief

This is a 2-year study involving the progressive reduction in the nicotine content of cigarettes. The investigators believe that at the end of the study smokers of cigarettes with progressively reduced nicotine content will be "weaned" from nicotine. At the end of the study, the result will be a decreased level of nicotine dependence. When smokers are again free to choose any smoking behavior, they will smoke fewer cigarettes and/or have a greater interest in quitting compared to a control group that smokes their usual cigarettes.

Key facts

Study ID

NCT00264342

Run by

University of California, San Francisco

People needed

135

Starts

2005-07-01

Expected to finish

2010-07-01

Last updated by the study team

2013-05-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy on the basis of medical history and screening blood tests
• Current moderate-to-heavy smoker as determined by:
• smoking more than 10 cigarettes per day regularly for the past year (by history); and
• expired carbon monoxide (CO) at screening visit of 25 ppm or more and/or plasma cotinine level of 100 ng/ml or more.
• Age 18-70 years
• Any racial/ethnic background

You may not qualify if…

• Expressed desire to quit smoking within 6 months.
• Significant medical conditions (such as anemia, heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants). Smokers with uncomplicated controlled hypertension may be enrolled.
• Pregnancy or lactation (by history)
• Current use of smokeless tobacco, pipes or cigars
• Alcohol abuse or illicit drug use (by history)
• Concurrent participation in another clinical trial or prior participation in our pilot studies using the same RNC cigarettes as in these studies

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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