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

NCT00264342 | Completed DMC

• 1 other identifier: R01CA078603-05A1
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Nicotine Dependence; Tobacco Use Disorder

Keywords

Smoking; Tobacco; Nicotine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Health adults 18 and over

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Related Publications (6)

• Benowitz NL, Jacob P 3rd, Bernert JT, Wilson M, Wang L, Allen F, Dempsey D. Carcinogen exposure during short-term switching from regular to "light" cigarettes. Cancer Epidemiol Biomarkers Prev. 2005 Jun;14(6):1376-83. doi: 10.1158/1055-9965.EPI-04-0667.

  PMID: 15941944 BACKGROUND

• Gray N, Henningfield JE, Benowitz NL, Connolly GN, Dresler C, Fagerstrom K, Jarvis MJ, Boyle P. Toward a comprehensive long term nicotine policy. Tob Control. 2005 Jun;14(3):161-5. doi: 10.1136/tc.2004.010272.

  PMID: 15923465 BACKGROUND

• Hukkanen J, Jacob P 3rd, Benowitz NL. Metabolism and disposition kinetics of nicotine. Pharmacol Rev. 2005 Mar;57(1):79-115. doi: 10.1124/pr.57.1.3.

  PMID: 15734728 BACKGROUND

• Arcavi L, Benowitz NL. Cigarette smoking and infection. Arch Intern Med. 2004 Nov 8;164(20):2206-16. doi: 10.1001/archinte.164.20.2206.

  PMID: 15534156 BACKGROUND

• Swan GE, Benowitz NL, Jacob P 3rd, Lessov CN, Tyndale RF, Wilhelmsen K, Krasnow RE, McElroy MR, Moore SE, Wambach M. Pharmacogenetics of nicotine metabolism in twins: methods and procedures. Twin Res. 2004 Oct;7(5):435-48. doi: 10.1375/1369052042335269.

  PMID: 15527659 BACKGROUND

• Benowitz NL, Gan Q, Goniewicz ML, Lu W, Xu J, Li X, Jacob P 3rd, Glantz S. Different profiles of carcinogen exposure in Chinese compared with US cigarette smokers. Tob Control. 2015 Dec;24(e4):e258-63. doi: 10.1136/tobaccocontrol-2014-051945. Epub 2014 Dec 22.

  PMID: 25535294 DERIVED

Related Links

• UCSF Nicotine and Tobacco Research

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue (blood) and urine

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Neal L Benowitz, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2005
• First Posted: December 12, 2005
• Study Start: July 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

US (1)