Identifying Treatments to Motivate Smokers to Quit (Motivation)
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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 |
- 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.
- 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.
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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.
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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.
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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.
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Wisconsin | |
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | |
| Madison, Wisconsin, United States, 53711-2027 | |
| 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 May 23, 2013