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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00534404 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Smoking Cessation Tobacco Use Disorder |
Drug: Nicotine patches Behavioral: Telephone counseling Behavioral: Quitnet.com Web site |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Trial of Internet Access to Nicotine Patches |
| Estimated Enrollment: | 2475 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Nicotine Patches, Telephone Counseling, and Internet: Experimental
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.
|
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.
|
|
Nicotine Patches and Internet: Active Comparator
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.
|
Drug: Nicotine patches
Participants will wear nicotine patches.
Behavioral: Quitnet.com Web site
Participants will access the Quitnet.com Web site.
|
|
Internet: Placebo Comparator
Research participants in this arm will have free access to internet-assisted tobacco treatment website.
|
Behavioral: Quitnet.com Web site
Participants will access the Quitnet.com Web site.
|
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:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Larry C. An, MD | 612-624-6925 | lcan@umn.edu |
| Contact: Colleen M. Klatt, PhD | 763-670-0065 | klat0040@umn.edu |
| Principal Investigator: | Larry C. An, MD | University of Minnesota - Clinical and Translational Science Institute |
More Information
| Responsible Party: | NHLBI ( Jared B. Jobe, Program Official ) |
| Study ID Numbers: | 511, R01 HL086684-01 |
| Study First Received: | September 21, 2007 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00534404 History of Changes |
| Health Authority: | United States: Federal Government |
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Internet-Assisted Tobacco Treatments Online Smoking Cessation Programs Nicotine Patches Telephone Counseling Smoking Abstinence |
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Smoking Nicotine polacrilex Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Nicotinic Agonists Tobacco Use Disorder Physiological Effects of Drugs Disorders of Environmental Origin Central Nervous System Stimulants Cholinergic Agents |
Pharmacologic Actions Habits Mental Disorders Nicotine Autonomic Agents Therapeutic Uses Substance-Related Disorders Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |
