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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00264342
First received: December 9, 2005
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition
Nicotine Dependence
Tobacco Use Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Safety of Nicotine Reduction Strategy

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Biospecimen Retention:   Samples Without DNA

Tissue (blood) and urine


Enrollment: 135
Study Start Date: July 2005
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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 will smoke progressively reduced nicotine content (RNC) cigarettes over a period of six months, and then remain on the lowest nicotine content cigarette for an additional six months. Comparisons will be made with a control group in which subjects will smoke their usual normal nicotine yield cigarettes. There will be a one year follow-up phase during which subjects will be monitored and will be free to resume smoking a commercial cigarette of their choice, or to quit.

We hypothesize that smokers of cigarettes with progressively reduced nicotine content will experience a reduction in nicotine intake without compensatory oversmoking. This will serve to "wean" them from nicotine and result in a decreased level of nicotine dependence. Once this has occurred, subjects will then be able to maintain their reduced level of nicotine intake for the 6 months that they continue smoking the lowest level RNC cigarette. When they are again free to choose any smoking behavior (follow-up phase), as a result of the period of lowered dependence they will smoke fewer cigarettes and/or have a greater interest in quitting compared to the control group, whose level of nicotine dependence is hypothesized to be sustained throughout.

Primary Hypotheses:

  1. Nicotine intake will be lower for the RNC group than for the control group.
  2. Exposure to tobacco smoke gas phase constituents will be similar for the RNC and control group.
  3. Exposure to tobacco smoke tar constituents will be similar for the RNC and control group.
  4. Cardiovascular biomarkers of inflammation, platelet activation, endothelial dysfunction, and HDL cholesterol will be lower for the RNC group than for the control group.
  5. Cigarette consumption, as measured by cigarettes-per-day (CPD), will be lower for the RNC group than for the control group.

Secondary hypotheses:

  1. Over the course of tapering and maintenance and at follow-up, interest in quitting will be higher in the RNC group compared to the control group.
  2. At follow-up, measures of cigarette consumption, nicotine intake, and exposure to tobacco smoke combustion constituents will be lower for the RNC group compared to the control group.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Health adults 18 and over

Criteria

Inclusion Criteria:

  • Healthy on the basis of medical history and screening blood tests
  • Current moderate-to-heavy smoker as determined by:

    1. smoking more than 10 cigarettes per day regularly for the past year (by history); and
    2. 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264342

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Neal L Benowitz, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00264342     History of Changes
Other Study ID Numbers: R01CA078603-05A1
Study First Received: December 9, 2005
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Smoking
Tobacco
Nicotine

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014