Official Title: “A Randomized Trial of Internet Access to Nicotine Patches”

People who smoke cigarettes have an increased risk of developing emphysema, heart disease, and certain types of cancer. This study will evaluate the effectiveness of providing free nicotine patches from an online smoking cessation program, with and without telephone counseling, at improving quit rates in cigarette smokers.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2012

Tobacco use is the single most preventable cause of death in the United States, with cigarette smoking accounting for nearly one-third of all cancer deaths each year. Although a number of inexpensive and effective smoking cessation methods exist, including the nicotine patch and nicotine gum, smoking rates have not declined in the past few years. More than 8 million people in this country use the Internet to seek assistance with quitting smoking.

Research suggests that people who use interactive smoking cessation Web sites typically only experience a short period of smoking abstinence. Smokers who receive nicotine patches in addition to online assistance are more than twice as likely to quit smoking. The purpose of this study is to evaluate the effectiveness of a combination of free nicotine patches and an online smoking cessation program, with and without access to telephone counseling, at improving smoking cessation rates in cigarette smokers.

This study will enroll people who accessed the Quitnet.com Web site. Participants will complete a baseline survey about their smoking habits and quit history. Participants will then be randomly assigned to one of the following three treatment groups: - Group 1 participants will receive free access to nicotine patches, telephone counseling, and Quitnet.com services. - Group 2 participants will receive free access to nicotine patches and Quitnet.com services. - Group 3 participants will receive Quitnet.com services.

Participants receiving telephone counseling will receive three phone calls over a 2-week period to discuss their personal smoking cessation plan; they must complete all three calls in order to receive the nicotine patches. At Months 1, 3, and 9, all participants will complete online surveys about their smoking cessation experience. Participants will be contacted by phone to complete the surveys if they do not complete them online.

Intervention(s) in this Clinical Trial

• Drug: Nicotine patches
  • Participants will wear nicotine patches.
• Behavioral: Telephone counseling
  • Participants receiving telephone counseling will receive three phone calls over a 2-week period to discuss their personal smoking cessation plan.
• Behavioral: Quitnet.com Web site
  • Participants will access the Quitnet.com Web site.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Nicotine Patches, Telephone Counseling, and Internet
  • As adjuncts to an internet-assisted tobacco treatment website, research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
• Active Comparator: Nicotine Patches and Internet
  • As adjuncts to an internet-assisted tobacco treatment, research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
• Placebo Comparator: Internet
  • Research participants in this arm will have free access to internet-assisted tobacco treatment website.

Primary Measures

• Self-reported 6-month prolonged abstinence from smoking
  • Time Frame: Measured at Month 9
    Safety Issue?: No

Inclusion Criteria:

• Currently smokes 10 or more cigarettes per day
• Actively searching online for smoking cessation assistance on the Quitnet.com Web site
• Does not use any tobacco products other than cigarettes
• Willing to set a quit date within 2 to 4 weeks following study entry
• Willing to use a nicotine patch
• Able to speak English
• Access to Internet, email, and telephone at work or home
• Resident of the United States
• Only one person per household is eligible to enroll

Exclusion Criteria:

• Medically unable to use the nicotine patch (e.g., pregnant, history of a heart attack)
• Currently uses nicotine replacement therapy (NRT) products
• Currently uses or plans to use Bupropion SR, Wellbutrin, or Zyban

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Overall Clinical Trial Officials and Contacts

Larry C. An, MD Principal Investigator University of Minnesota  

Overall Contact: Larry C. An, MD 612-624-6925 lcan@umn.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00534404

Study ID Number: 511

ClinicalTrials.gov Identifier: NCT00534404

Health Authority: United States: Federal Government