Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit

PHASE4CompletedINTERVENTIONAL
Enrollment

577

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

March 19, 2019

Study Completion Date

March 19, 2019

Conditions
SmokingMotivationSmoking Cessation
Interventions
DRUG

Nicotine Mini-Lozenge

If randomized to only the Nicotine Mini-Lozenge condition: Participants randomized to this condition will receive up to a 12 month supply of 2 mg or 4 mg nicotine mini-lozenges. Mini-Lozenges will be given at the initial visit and over the course of the whole study. Participants will be instructed to use 9 pieces daily for the 12 months.

BEHAVIORAL

Behavioral Reduction Counseling

We will deliver BR in 10 (10-15 minute) sessions over a 52-week period, with an in-person session at Visit 1 followed by nine phone counseling sessions. Sessions are front-loaded to enhance acquisition of new behaviors. BR Counseling will emphasize the development of smoking control skills via feasible, specific, and graded assignments of smoking reduction activities that will be tracked over time. BR will also emphasize competence and self-efficacy, both which will be directly linked to the practice of smoking reduction skills and success in smoking control. The health counselor will provide rationales for the reduction intervention, why reduction (e.g., eliminating smoking contexts) should help the smoker, and provide the participant with specific exercises and goals. The health counselor will explicitly address pragmatic issues such as work contexts, smoking policies, and habits that interfere with smoking reduction efforts.

BEHAVIORAL

5Rs Motivation Counseling

"The 5Rs Motivation Counseling will be delivered in four (10-15 min) sessions over a 52-week period. Participants in the on condition will receive three brief phone sessions over the year to prompt processing of motives for smoking reduction or cessation. The health counselor and smoker will discuss: 1) Relevance of smoking to the individual; 2) Risks of continued heavy smoking; 3) Rewards of quitting and significant reduction; and 4) Roadblocks to success; and will do so on a 5) Repeated basis. The discussion will follow the general principles of MI: counselors will use strategies that are nonauthoritarian, nonconfrontational, supportive, and use open-ended questions."

BEHAVIORAL

Behavioral Activation Counseling

The BA treatment will be delivered in 10 (10-15 minute) sessions over a 52-week period starting with Visit 1 followed by nine phone counseling sessions. This BA treatment will be modeled after Behavioral Activation for quitting smoking, but made relevant for smoking reduction. Treatment goals focus on helping participants engage in positively reinforcing activities while not smoking. The treatment includes: 1) a rationale for the BA exercises as they relate to smoking (e.g., engaging in non-smoking reinforcers will provide other sources of pleasure and assist with cutting down); 2) assessment of the participant's goals, values, and reinforcing value of current nonsmoking activities; 3) training in self-monitoring using an activity log; 4) ongoing assignments of activities that should significantly increase the participant's nonsmoking reinforcement and create broader lifestyle and cue exposure changes; and 5) problem-solving to address obstacles to goal attainment.

OTHER

No Treatment

No Treatment

Trial Locations (1)

53711-2027

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health, Madison

All Listed Sponsors
collaborator

Penn State University

OTHER

collaborator

University of Illinois at Chicago

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

University of Wisconsin, Madison

OTHER

NCT02354872 - Motivation Project: Testing Intervention Components for the Smoker Who is Unwilling to Quit | Biotech Hunter | Biotech Hunter