Identifying Treatments to Motivate Smokers to Quit (Motivation)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Illinois at Chicago
Dean Health System
Mercy Health System
Aurora Health Care
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01122238
First received: May 7, 2010
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

At any given point in time, most smokers are not interested in making a serious quit attempt. Data suggest that 30% of smokers have no plans to quit, 30% plan to quit at some future date, 30% plan to quit in the next 6 months, and about 10% plan to quit in the next month. While ~40% of smokers make a quit attempt each year, only about 4-6% of those achieve long-term success. This means that of the more than 60 million Americans who smoke, only 1 million are able to quit each year. If we could double the number of quit attempts and maintain comparable success rates, we could double the number of individuals who will benefit from living smoke free lives. These observations underscore the need to develop interventions that increase smokers' motivation or willingness to make quit attempts, and that also increase the rate of success among those who attempt to quit. The overall goal of this proposed experiment is to identify effective interventions aimed at increasing motivation for smoking cessation, increasing quit attempts, and increasing rates of cessation success. Interventions that will be tested include: use of nicotine gum, use of nicotine patches, motivational interviewing, and smoking reduction counseling. At minimum, all participants will complete surveys about their smoking behavior that might increase their motivation to eventually quitting smoking.


Condition Intervention Phase
Smoking
Smoking Cessation
Motivation
Nicotine
Drug: Nicotine Patch
Drug: Nicotine Gum
Behavioral: Motivational Interviewing
Behavioral: Smoking Reduction
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Identifying Optimal, Translatable Smoking Cessation Intervention Components

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Occurrence of a quit attempt. [ Time Frame: Assessed at each assessment phone contact (Weeks 1-6) and at each follow up contact (12 weeks and 26 weeks) ] [ Designated as safety issue: No ]
    A binary measure defined as no smoking for at least 24 hours because of an attempt to quit smoking.

  • Point prevalence abstinence [ Time Frame: Assessed at each follow-up contact (12 weeks and 26 weeks). ] [ Designated as safety issue: No ]
    Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.

  • Motivation to quit smoking [ Time Frame: Assessed at Visit 1, at each assessment phone contact (Weeks 1-6), and at each follow up contact (12 weeks and 26 weeks). ] [ Designated as safety issue: No ]
    1) Self-reported plans to quit smoking in the next 3 months; 2) continuous measure of motivation to quit smoking.


Secondary Outcome Measures:
  • Prolonged abstinence [ Time Frame: Assessed through the 26 week follow-up contact. ] [ Designated as safety issue: No ]
    Defined as self-reported longest period without smoking between follow-up contacts(i.e.,12 weeks and 26 weeks).

  • Number of Cigarettes smoked [ Time Frame: Assessed at Visit 1, at each assessment phone contact (Weeks 1-6), and at each follow up contact (12 weeks and 26 weeks). ] [ Designated as safety issue: No ]
    Self-reported reported number of cigarettes smoked each day.

  • Self-report of a serious quit attempt. [ Time Frame: Assessed at each assessment phone contact (Weeks 1-6) and at each follow up contact (12 weeks and 26 weeks) . ] [ Designated as safety issue: No ]
    A self-reported serious quit attempt that occurred since the last contact.


Estimated Enrollment: 640
Study Start Date: June 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotine Gum

Comparison of nicotine gum and no nicotine gum.

This arm of the project will address the following question:

Does nicotine gum, compared to no nicotine gum, improve motivation to quit, increase quit attempts, and/or increase point prevalence abstinence?

Drug: Nicotine Gum
Participants randomized to this condition will receive a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks.
Experimental: Nicotine Patch

Comparison of nicotine patch and no nicotine patch.

This arm of the project will address the following question:

Does the nicotine patch, compared to no patch, improve motivation to quit, increase quit attempts, and/or increase point prevalence abstinence?

Drug: Nicotine Patch
Participants randomized to this condition will receive a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks.
Experimental: Smoking Reduction Counseling

This arm will allow us to address the following question:

Does smoking reduction counseling, compared to no smoking reduction counseling, improve motivation to quit, increase quit attempts, and/or increase point prevalence abstinence?

Behavioral: Smoking Reduction
Participants randomized to Smoking Reduction will receive an initial counseling session during the in-person visit followed by 6 weekly phone counseling sessions over the 6-week intervention period. During the initial session, participants will be told that the goal is to reduce cigarette consumption by 50% over the course of the intervention (approximately 10% reduction per week). During the initial meeting and subsequent counseling calls, case managers will work with participants to problem-solve strategies for reduction (e.g., increasing time between cigarettes, delaying smoking, or eliminating smoking in specific situations). Participants will be asked to record information in a provided smoking log to help keep track of daily smoking patterns and as a feedback mechanism for identifying successes and challenges.
Experimental: Motivational Interviewing (MI).

This arm of the project will address the following question:

Does a motivational interviewing (MI) intervention, compared to no MI, improve motivation to quit, increase quit attempts, and/or increase point prevalence abstinence?

Behavioral: Motivational Interviewing
Participants randomized to this condition will receive an initial MI counseling session during the in-person clinic visit followed by three counseling phone calls over the 6-week intervention period (a total of four intervention contacts). The phone counseling sessions will occur during weeks 2, 4, and 6. Case managers will engage the participant in a series of motivation building exercises such as reviewing feelings and thoughts about the pros and cons of quitting and smoking, reinforcing the positives of quitting, helping to dispel myths and concerns about the negatives of quitting, and posing questions about the "good" aspects of smoking.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older;
  • Report smoking at least 5 cigarettes per day for the previous 6 months;
  • Able to read and write English;
  • Available to take one phone call per week;
  • Not currently interested in quitting smoking (defined as would not like to try to quit in the next 30 days),
  • Plans to remain in the intervention catchment area for at least 12 months
  • All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study.

Exclusion Criteria:

  • Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study);
  • Study candidate is a pregnant, trying to get pregnant, or nursing;
  • A history of psychosis or bipolar disorder
  • A history of skin or allergic reactions while using a nicotine patch.
  • Study candidate reports having a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122238

Locations
United States, Wisconsin
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States, 53711-2027
Sponsors and Collaborators
University of Wisconsin, Madison
University of Illinois at Chicago
Dean Health System
Mercy Health System
Aurora Health Care
Investigators
Study Chair: Michael C. Fiore, MD, MPH, MBA University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Study Director: Jessica Cook, PhD University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Principal Investigator: Robin Mermelstein, PhD Institute for Health Research and Policy, University of Illinois at Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01122238     History of Changes
Other Study ID Numbers: H-2009-0203, 9P50CA143188
Study First Received: May 7, 2010
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Smoking
Smoking Cessation
Motivation
Nicotine

Additional relevant MeSH terms:
Smoking
Habits
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 April 15, 2014