A Randomized Trial of Internet Access to Nicotine Patches (iQS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lawrence C. An, University of Michigan
ClinicalTrials.gov Identifier:
NCT00534404
First received: September 21, 2007
Last updated: January 30, 2014
Last verified: January 2014
  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: iQuit Smoking website

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: iQuit Smoking: A Randomized Trial of Internet Access to Nicotine Patches

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Self-reported 6-month prolonged abstinence from smoking [ Time Frame: Measured at 9 Months post-enrollment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Self-reported 30-day prolonged abstinence at 3- and 9-month follow up [ Time Frame: 3 months post enrollment, 9 months post enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 2475
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NRT Patch, Phone Counseling, Internet
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
Participants will wear nicotine patches.
Other Name: Nicoderm CQ
Behavioral: Telephone counseling
Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
Behavioral: iQuit Smoking website
Participants will access the Project Quit (iQuit Smoking) website.
Active Comparator: Nicotine Patches and Internet
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
Participants will wear nicotine patches.
Other Name: Nicoderm CQ
Behavioral: iQuit Smoking website
Participants will access the Project Quit (iQuit Smoking) website.
Placebo Comparator: Internet
Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).
Behavioral: iQuit Smoking website
Participants will access the Project Quit (iQuit Smoking) website.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

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
  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: NCT00534404

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Lawrence C An, MD University of Michigan
  More Information

No publications provided

Responsible Party: Lawrence C. An, Associate Professor of Internal Medicine, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT00534404     History of Changes
Other Study ID Numbers: 511, R01HL086684-01
Study First Received: September 21, 2007
Last Updated: January 30, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Internet-Assisted Tobacco Treatments
Online Smoking Cessation Programs
Nicotine Patches
Telephone Counseling
Smoking Abstinence

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014