Identifying Treatments to Motivate Smokers to Quit

Summary

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.

Conditions

• Smoking
• Smoking Cessation
• Motivation
• Nicotine Dependence

Interventions

DRUG

Nicotine Patch

If randomized to only the Nicotine Patch condition (and not the Nicotine Gum): 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.

DRUG

Nicotine Gum

If randomized to only the Nicotine Gum condition (and not the Nicotine Patch): 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.

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.

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.

OTHER

No Intervention

No Intervention

DRUG

Nicotine Patch + Nicotine Gum

If randomized to both the Nicotine Patch and the Nicotine Gum conditions: Participants randomized to this condition will receive a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks.

Sponsors & Collaborators

• University of Illinois at Chicago

  collaborator OTHER

• Dean Health System

  collaborator OTHER

• Mercy Health System

  collaborator NETWORK

• Wake Forest University Health Sciences

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Michael C. Fiore, MD, MPH, MBA · University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

• Jessica Cook, PhD · University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

• Robin Mermelstein, PhD · Institute for Health Research and Policy, University of Illinois at Chicago

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2014-05-31

Completion

2014-05-31

Countries

• United States

Study Locations