Nicotine Therapy Sampling to Induce Quit Attempts Among Smokers Unmotivated to Quit a Randomized Clinical Trial

ORIGINAL INVESTIGATION Nicotine Therapy Sampling to Induce Quit Attempts Among Smokers Unmotivated to Quit A Randomized Clinical Trial Matthew J. Carpenter, PhD; John R. Hughes, MD; Kevin M. Gray, MD; Amy E. Wahlquist, MS; Michael E. Saladin, PhD; Anthony J. Alberg, PhD, MPH Background: Rates of smoking cessation have not abstinence at any time during the study (ie, floating changed in a decade, accentuating the need for novel ap- abstinence) and at the final follow-up assessment. proaches to prompt quit attempts. Results: Compared with PQA intervention, nicotine Methods: Within a nationwide randomized clinical therapy sampling was associated with a significantly higher trial (N=849) to induce further quit attempts and ces- incidence of any quit attempt (49% vs 40%; relative risk sation, smokers currently unmotivated to quit were [RR], 1.2; 95% CI, 1.1-1.4) and any 24-hour quit at- randomized to a practice quit attempt (PQA) alone or tempt (43% vs 34%; 1.3; 1.1-1.5). Nicotine therapy sam- to nicotine replacement therapy (hereafter referred to pling was marginally more likely to promote floating ab- as nicotine therapy), sampling within the context of a stinence (19% vs 15%; RR, 1.3; 95% CI, 1.0-1.7); 6-month PQA. Following a 6-week intervention period, partici- point prevalence abstinence rates were no different be- pants were followed up for 6 months to assess out- tween groups (16% vs 14%; 1.2; 0.9-1.6). comes. The PQA intervention was designed to increase motivation, confidence, and coping skills. The combi- Conclusion: Nicotine therapy sampling during a PQA nation of a PQA plus nicotine therapy sampling added represents a novel strategy to motivate smokers to make samples of nicotine lozenges to enhance attitudes a quit attempt. toward pharmacotherapy and to promote the use of additional cessation resources. Primary outcomes Trial Registration: clinicaltrials.gov Identifier: included the incidence of any ever occurring self- NCT00706979 defined quit attempt and 24-hour quit attempt. Sec- ondary measures included 7-day point prevalence Arch Intern Med. 2011;171(21):1901-1907 ESPITE ADVANCES IN and understudied target for public clinical care and policy, health. rates of smoking cessation have held constant in the past decade,1 indi- See Invited Commentary Dcating a need for novel approaches.2 at end of article Strategies to further prompt quitting must increase quit attempts or the likeli- For smokers unmotivated to quit, the hood that each quit attempt succeeds.3 immediate goal is to promote quit at- Author Affiliations: Most strategies focus on the latter, leav- tempts, a strategy referred to as cessation Departments of Psychiatry and ing few options for smokers who have induction. Cessation induction studies2,7,8 Behavioral Sciences differ from traditional cessation trials in at (Drs Carpenter and Gray) and Health Sciences and Research See also pages 1887, 1894, least the following 2 ways: (1) the target (Dr Saladin), Division of 1950, and 1956 population is smokers without current in- Biostatistics and Epidemiology, tention to quit (smokers unmotivated to Department of Medicine little interest in quitting in the near quit) and (2) the studies primarily focus on (Drs Carpenter and Alberg and future. Many smokers say they want to prompting quit attempts (abstinence is the Ms Wahlquist), and Hollings quit eventually,4 but in any given year, eventual goal but is secondary). Cancer Center (Drs Carpenter approximately 60% do not try to quit5 In contrast to policy interventions,9-11 and Alberg), Medical University and less than 10% of smokers plan to quit clinical interventions for promoting quit at- of South Carolina, Charleston; 6 and Department of Psychiatry, in the next month. Therefore, most tempts have received less attention, and the University of Vermont, and smokers are ambivalent about or resistant options are narrow. The most common Fletcher Allen Health Care, to quitting in the near future. These method of increasing motivation to quit is Burlington (Dr Hughes). unmotivated smokers are an important physician-delivered brief advice.3 A more ARCH INTERN MED/ VOL 171 (NO. 21), NOV 28, 2011 WWW.ARCHINTERNMED.COM 1901 ©2011 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/25/2021 time-intensive clinical option is motivational interviewing.12 have no Food and Drug Administration contraindications for Both physician advice and motivational interviewing rely nicotine lozenge use, (6) have no previous NT use, and (7) have onrepeatedcounseling,whichcouldovertimefrustrateboth no quit attempt longer than 1 week in the past year. smokers and clinicians. Furthermore, many physicians lack To recruit smokers who were unmotivated to quit, eligible confidence in smoking counseling.13 New strategies that do participants were offered the following 2 comparable study options: one for smokers wanting to quit in the next 30 days and not rely exclusively on verbal counseling could provide an another for smokers who wanted to quit at some later time but alternativetosmokerswhohavenotrespondedtophysician- not in the next 30 days. Self-selection into either option de- delivered brief advice in the past. noted motivation to quit; only those who chose the latter study Committing to quit is difficult for many smokers be- option were included in this study. cause they have failed in the past and fear embarrassment if unsuccessful.14 An alternative is to have smokers engage GENERAL PROCEDURES in less-threatening cessationlike activities, such as a practice quit attempt (PQA) (eg, attempting to not smoke for Eligible participants were mailed an informed consent form a few hours or days, without pressure to permanently quit). and were asked to return a signed copy if they wished to A successful PQA experience could increase self-efficacy participate. Participants were then randomized to treatment and teach coping skills for quitting. Practice quit attempts groups in a 1:1 ratio using a random number generator with have been recommended15,16 but have not been empiri- block randomization. Research staff then made calls to initi- cally tested. In addition, if smokers unmotivated to quit ate formal study enrollment. Of 943 who initially signed and returned consent forms, 94 (10.0%) could not be reached by sample cessation medication such as nicotine replace- telephone (Figure 1). The remaining 849 participants com- ment therapy (NT) (hereafter referred to as nicotine therapy) prised the final study sample. during a PQA, its therapeutic benefits could empower them Blinding study staff and participants to study group was in- to make a quit attempt. Despite strong evidence that NT is feasible because the intervention was behaviorally based. The efficacious,3,17 52% to 78% of smokers never use these prod- intervention consisted of 3 telephone calls during 6 weeks. Both ucts.18-20 Underuse of cessation pharmacotherapy in part treatment conditions were matched for duration. Approxi- reflects misperception and doubt,21-24 which could be re- mately 5% of telephone calls were randomly recorded and moni- versed through real-world NT sampling. tored regularly for treatment fidelity against semiscripted pro- A 2008 study25 of one-time NT use demonstrated a posi- tocols. At the last treatment telephone call, participants in both tive shift in attitudes but did not test for effects on cessation groups were given brief advice to quit smoking. Follow-up telephone contacts were made at weeks 4, 12, and 26 following behavior. Offering NT to motivated smokers (eg, callers to the end of treatment to ascertain study outcomes. Across 5094 a quitline) has been shown to increase quit attempts and (849ϫ6) scheduled telephone calls, 90% were completed; 73% 26-28 abstinence. This provides indirect support for the poten- of participants completed all 6 telephone calls, without signifi- tial efficacy of NT sampling, but it is unknown whether a cant group differences in retention. similar intervention would influence smokers unmotivated to quit. This article reports on a randomized trial of NT sam- INTERVENTIONS pling during PQAs as a novel method to induce quit attempts among smokers unmotivated to quit. Primarily, we hypoth- The primary focus of the study was NT sampling. This was em- esizedthatNT-aidedPQAswouldresultinahigherincidence bedded within the behavioral exercise of a PQA. of subsequent attempts to permanently quit smoking compared with PQAs alone. Secondarily, we hypothesized that Practice Quit Attempt NT sampling would result in higher 7-day point prevalence abstinence at the 6-month final follow-up assessment. The PQA was designed with the intent to pause from smoking and to reflect on the process of quitting. We discussed with the smoker that quitting often requires practice before succeeding and METHODS that a PQA can be a good opportunity to practice and build confidence. The central theme of the PQA was to remove pressure Trial methods and a detailed rationale for the study design have of trying to permanently quit smoking. Telephone counselors been reported elsewhere.29 In this randomized 2-group study worked collaboratively with each participant to establish a PQA design, smokers who were unmotivated to quit were assigned plan that lasted a few hours or a few days or simply to see how (1) to a PQA alone or (2) to NT sampling within the context long he or she could go without smoking. Participants were not of a PQA. The study was approved by the Institutional Review required to engage in a PQA. At the second intervention tele- Board of the Medical University of South Carolina. phone call (week −3), the success and barriers of the first PQA were reviewed, and a second PQA was solicited. After both in- PARTICIPANTS tervention telephone calls, support materials were mailed, in- cluding further rationale for the PQA and coping strategies. The Participants were recruited from January 5, 2009, to February third and final treatment telephone call (week 0) reviewed over- 10, 2010, via the Internet using an e-mail database of potential all progress and changed the focus to permanently quitting.

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