Status:
COMPLETED
Effectiveness of Using Reduced Nicotine Cigarettes in Men and Women Smokers to Combat Nicotine Addiction
Lead Sponsor:
University of California, San Francisco
Conditions:
Nicotine Dependence
Tobacco Use Disorder
Eligibility:
All Genders
18-70 years
Brief Summary
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 reduce...
Detailed Description
This is a 2-year, randomized, two-arm study involving a 6-month period of progressive reduction in the nicotine content of cigarettes. During the first year (tapering/maintenance phases), subjects wil...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00264342
Start Date
July 1 2005
End Date
July 1 2010
Last Update
May 23 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco
San Francisco, California, United States, 94110