A Randomized Trial of Internet Access to Nicotine Patches

NCT00534404 | Completed Results DMC

• 2 other identifiers: 511R01HL086684-01
• Study Type: interventional
• Target: 2,485
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation; Tobacco Use Disorder

Keywords

Internet-Assisted Tobacco Treatments; Online Smoking Cessation Programs; Nicotine Patches; Telephone Counseling; Smoking Abstinence

Outcome Measures

Primary Outcomes (1)

• Self-reported 6-month Prolonged Abstinence From Smoking

  Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.

  Measured at 9 Months post-randomization

Secondary Outcomes (2)

• Self-reported 30-day Prolonged Abstinence at 9-month Follow up

  9 months post randomization

• Self-reported 30-day Prolonged Abstinence at 3-month Follow up

  3-months post randomization

Study Arms (3)

NRT Patch, Phone Counseling, Internet

EXPERIMENTAL

As adjuncts to internet-assisted tobacco treatment (iQuit Smoking 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; Behavioral: Telephone counseling; Behavioral: iQuit Smoking website

Nicotine Patches and Internet

ACTIVE COMPARATOR

As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), 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; Behavioral: iQuit Smoking website

Internet

PLACEBO COMPARATOR

Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).

Behavioral: iQuit Smoking website

Interventions

Nicotine patches DRUG

Participants will wear nicotine patches.

Also known as: Nicoderm CQ

NRT Patch, Phone Counseling, Internet; Nicotine Patches and Internet

Telephone counseling BEHAVIORAL

Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.

NRT Patch, Phone Counseling, Internet

iQuit Smoking website BEHAVIORAL

Participants will access the Project Quit (iQuit Smoking) website.

Internet; NRT Patch, Phone Counseling, Internet; Nicotine Patches and Internet

Eligibility Criteria

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

You may qualify if:

• Currently smokes 10 or more cigarettes per day
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Larry An, MD
• Organization: University of Michigan

lcan@med.umich.edu

734-763-6099

Study Officials

• Lawrence C An, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine, Medical School

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 24, 2007
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 3, 2015
• Results First Posted: February 3, 2015

Record last verified: 2015-01

Locations

US (1)