The Long-Term Quitting (Smoking Cessation) Study

Summary

Relapse after a serious quit attempt occurs in 70-90% of smokers who try to quit smoking. This study utilizes a sequential, multiple assignment, randomized trial (SMART) design - - an innovative multi-phase approach - - to test post-relapse treatments designed to assist smokers to make a new, successful quit attempt. This study will test Relapse Recovery (RR) treatments that are applied at two stages following relapse: 1) RR Preparation Phase treatments for smokers who relapse after an initial quit attempt, and 2) RR Cessation Phase treatments for relapsed smokers who decide to make a new quit attempt. Smokers motivated to quit smoking will make an initial quit attempt in the Quit Phase (cessation medication + counseling). Participants who relapse will be randomized to one of three RR Preparation Phase treatments (Behavioral \[Smoking\] Reduction Counseling + the Nicotine Mini-Lozenge; Recycling Counseling that encourages participants to quit again as soon as possible; and Preparation Phase Control). RR Preparation Phase participants (other than controls) who elect to try a new quit attempt will be randomized to one of four RR Cessation Phase treatments based on a 2X2 fully-crossed factorial design testing two factors: Supportive Counseling (vs. Brief Information) and Skill Training (vs. Brief Information). All RR Cessation Phase participants will receive 8 weeks of combination nicotine replacement therapy (nicotine patch + nicotine mini-lozenge). The investigators hypothesize that RR Preparation Phase Reduction treatment will significantly increase long-term abstinence rates relative to the Preparation Phase Control condition.

Conditions

• Smoking Cessation

Interventions

DRUG

Nicotine Mini-Lozenge for 11 Months

Participants receive up to 11 months of Nicotine Mini-Lozenges as part of this treatment (dosing based on their nicotine dependence as measured when they started the study: 4 mg if they smoked within 30 minutes of waking and 2 mg if they smoked more than 30 minutes after waking, as per the package insert), along with instructions for use.

BEHAVIORAL

Preparation Phase Behavioral Reduction Counseling

Participants randomized to receive this treatment receive manual-based counseling calls and visits over the course of 11 months. The ultimate goal will be smoking that is reduced in amount and location. Case managers and participants will collaboratively identify a set of steps to progressively reduce smoking. The primary vehicles for change are to encourage substitution of the nicotine mini-lozenge for cigarettes and to reduce the contexts in which smoking occurs. Counseling will counter post-lapse demoralization by emphasizing participants' progress, the value of smoking reduction as a transitional goal, and the critical value of ongoing treatment engagement. Evidence of progress in reduction of smoking, and smoking contexts will be used to build self-efficacy.

BEHAVIORAL

Preparation Phase Recycling Counseling

Participants randomized to receive this treatment condition will be encouraged to commit to a new quit date as soon as they feel ready. In the counseling sessions, participants will be encouraged to discuss reasons for and concerns about quitting as well as barriers to setting a quit date.

BEHAVIORAL

Preparation Phase Control Treatment

Participants randomly assigned to the Preparation Phase Control Treatment condition will continue to receive the Initial Cessation usual care treatment (8 weeks of nicotine patch; two coaching sessions), but will also be told that they can receive additional treatment at no cost from the Wisconsin Tobacco Quitline (WTQL).

BEHAVIORAL

Cessation Phase Supportive Counseling

Supportive Counseling will be consistent with the Public Health Service (PHS) Clinical Practice Guideline (Fiore et al., 2008) and will involve encouragement, a focus on short-term goals, discussion of participant values (what the participant feels would be good and healthy for them in the long run) and how these values are congruent with cessation, emphasis on the patient and the counselor being a team, encouragement for the participant to generate a quitting strategy with the message that smokers often have a good sense of what will work for them, and prompts for the participant to explore his/her feelings about quitting and feelings of optimism and concern (i.e., to use the counselor as a sounding board).

BEHAVIORAL

Cessation Phase Skill Training Counseling

Skill training Counseling will: 1) carefully assess smoking cue contexts and opportunities to smoke, to identify problems encountered in the prior quit attempt; 2) develop specific plans for avoiding such contexts and identify skills for coping with them; 3) develop plans for negotiating with others who smoke; 4) develop lifestyle changes to reduce future smoking opportunities and contexts; and 5) assign homework and assess execution of assigned skills. Participants will receive coping menus that provide personalized coping/avoidance options and "coping reports" that assess coping execution over time and troublesome contexts and cues around which counseling will be focused. There will be praise for any progress and a collaborative determination of barriers to skill execution.

BEHAVIORAL

Cessation Phase Brief Information

Participants randomized to receive Brief Information will receive brief (generic) information about the importance of taking the cessation medication, how to use the medication, information about side effects/safety, and what to do in case of problems, and will also be given encouragement to quit smoking.

DRUG

Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge

All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke \>10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke \<=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).

Sponsors & Collaborators

• Penn State University

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Tanya Schlam, PhD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-30

Primary Completion

2019-11-05

Completion

2019-11-05

Countries

• United States

Study Locations