Motivational interviewing to enhance nicotine patch treatment for smoking cessation among homeless smokers: a randomized controlled trial.
ABSTRACT: To assess the effects of adding motivational interviewing (MI) counseling to nicotine patch for smoking cessation among homeless smokers.Two-group randomized controlled trial with 26-week follow-up.A total of 430 homeless smokers from emergency shelters and transitional housing units in Minneapolis/St Paul, Minnesota, USA.All participants received 8-week treatment of 21-mg nicotine patch. In addition, participants in the intervention group received six individual sessions of MI counseling which aimed to increase adherence to nicotine patches and to motivate cessation. Participants in the standard care control group received one session of brief advice to quit smoking. Primary outcome was 7-day abstinence from cigarette smoking at 26 weeks, as validated by exhaled carbon monoxide and salivary cotinine.Using intention-to-treat analysis, verified 7-day abstinence rate at week 26 for the intervention group was non-significantly higher than for the control group (9.3% versus 5.6%, P?=?0.15). Among participants who did not quit smoking, reduction in number of cigarettes from baseline to week 26 was equally high in both study groups (-13.7?±?11.9 for MI versus -13.5?±?16.2 for standard care).Adding motivational interviewing counseling to nicotine patch did not increase smoking rate significantly at 26-week follow-up for homeless smokers.
Project description:BACKGROUND:Tobacco use is higher among homeless individuals than the general population. Homeless individuals are also more likely to have symptoms of depression. Depression symptoms may add to the burden of homelessness by increasing psychological distress and serve as a barrier to quitting smoking. OBJECTIVES:The primary goal of this study is to assess the impact of depression symptoms on psychological distress in homeless smokers. The effect of depression symptoms on abstinence and the effect of Motivational Interviewing (MI) on cessation among smokers is also explored. METHODS:Homeless smokers (N = 430) enrolled in a smoking cessation study were randomized to Motivational Interviewing (MI) or standard care (SC). Participants received nicotine replacement therapy and were followed for 26 weeks. Participants were categorized into a depression symptoms (DS) group or control group using the Patient Health Questionnaire-9. Between group differences of perceived stress, hopelessness, confidence, craving and abstinence were assessed at weeks 8 and 26. The interaction between depression symptoms (levels: DS and control) and the intervention (levels: MI and SC) was also assessed. RESULTS:Homeless smokers in the DS group reported higher levels of hopelessness, perceived stress, and craving. There was no effect of DS status on abstinence at week 8 or week 26. There was no significant interaction between depression symptoms (DS vs. Control) and the intervention (MI vs. SC). CONCLUSION:Despite reporting greater psychological distress, homeless smokers with depression symptoms in this sample had abstinence levels similar to the control group. Future research should explore protective factors among depressed smokers.
Project description:Although smoking prevalence remains strikingly high in homeless populations (~70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers.To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants (n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes.Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders.Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week to protect against attrition; and (5) regular and persistent calls to remind participants of upcoming appointments using cell phones and shelter-specific channels of communication.The study's limitations include generalizability due to the sample drawn from a single Midwestern city in the United States. Since inclusion criteria encompassed willingness to use NRT patch, all participants were motivated and were ready to quit smoking at the time of enrollment in the study. Findings from the self-select group will be generalizable only to those motivated and ready to quit smoking. High incentives may limit the degree to which the intervention is replicable.Lessons learned reflect the need to engage communities in the design and implementation of community-based clinical trials with vulnerable populations.
Project description:AIMS:To screen promising intervention components designed to reduce smoking and promote abstinence in smokers initially unwilling to quit. DESIGN:A balanced, four-factor, randomized factorial experiment. SETTING:Eleven primary care clinics in southern Wisconsin, USA. PARTICIPANTS:A total of 517 adult smokers (63.4% women, 91.1% white) recruited during primary care visits who were willing to reduce their smoking but not quit. INTERVENTIONS:Four factors contrasted intervention components designed to reduce smoking and promote abstinence: (1) nicotine patch versus none; (2) nicotine gum versus none; (3) motivational interviewing (MI) versus none; and (4) behavioral reduction counseling (BR) versus none. Participants could request cessation treatment at any point during the study. MEASUREMENTS:The primary outcome was percentage change in cigarettes smoked per day at 26?weeks post-study enrollment; the secondary outcomes were percentage change at 12 weeks and point-prevalence abstinence at 12 and 26 weeks post-study enrollment. FINDINGS:There were few main effects, but a significant four-way interaction at 26?weeks post-study enrollment (P?=?0.01, ??=?0.12) revealed relatively large smoking reductions by two component combinations: nicotine gum combined with BR and BR combined with MI. Further, BR improved 12-week abstinence rates (P?=?0.04), and nicotine gum, when used without MI, increased 26-week abstinence after a subsequent aided quit attempt (P?=?0.01). CONCLUSIONS:Motivation-phase nicotine gum and behavioral reduction counseling are promising intervention components for smokers who are initially unwilling to quit.
Project description:BACKGROUND:Despite progress in reducing cigarette smoking in the general U.S. population, smoking rates, cancer morbidity and related heart disease remain strikingly high among the poor and underserved. Homeless individuals' cigarette smoking rate remains an alarming 70% or greater, and this population is generally untreated with smoking cessation interventions. Furthermore, the majority of homeless smokers also abuse alcohol and other drugs, which makes quitting more difficult and magnifies the health consequences of tobacco use. METHODS/DESIGN:Participants will be randomized to one of three groups, including (1) an integrated intensive smoking plus alcohol intervention using cognitive behavioral therapy (CBT), (2) intensive smoking intervention using CBT or (3) usual care (i.e., brief smoking cessation and brief alcohol counseling). All participants will receive 12-week treatment with a nicotine patch plus nicotine gum or lozenge. Counseling will include weekly individual sessions for 3 months, followed by monthly booster group sessions for 3 months. The primary smoking outcome is cotinine-verified 7-day smoking abstinence at follow-up week 52, and the primary alcohol outcome will be breathalyzer-verified 90-day alcohol abstinence at week 52. DISCUSSION:This study protocol describes the design of the first community-based controlled trial (n = 645) designed to examine the efficacy of integrating alcohol abuse treatment with smoking cessation among homeless smokers. To further address the gap in effectiveness of evidence-based smoking cessation interventions in the homeless population, we are conducting a renewed smoking cessation clinical trial called Power to Quit among smokers experiencing homelessness. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01932996. Date of registration: 20 November 2014.
Project description:Introduction:Three-quarters of homeless people smoke cigarettes. Financial incentives for smoking abstinence have appeared promising in nonexperimental studies of homeless smokers, but randomized controlled trial (RCT) data are lacking. Methods:We conducted a pilot RCT of financial incentives for homeless smokers. Incentive arm participants (N = 25) could earn escalating $15-$35 rewards for brief smoking abstinence (exhaled carbon monoxide <8 parts per million) assessed 14 times over 8 weeks. Control arm participants (N = 25) were given $10 at each assessment regardless of abstinence. All participants were offered nicotine patches and counseling. The primary outcome was a repeated measure of brief smoking abstinence across 14 assessments. The secondary outcome was brief abstinence at 8 weeks. Exploratory outcomes were self-reported 1-day and 7-day abstinence from (1) any cigarette and (2) any puff of a cigarette. Other outcomes included 24-hour quit attempts, nicotine patch use, counseling attendance, and changes in alcohol and drug use. Results:Compared to control, incentive arm participants were more likely to achieve brief abstinence overall (odds ratio 7.28, 95% confidence interval 2.89 to 18.3) and at 8 weeks (48% vs. 8%, p = .004). Similar effects were seen for 1-day abstinence, but 7-day puff abstinence was negligible in both arms. Incentive arm participants made more quit attempts (p = .03). Nicotine patch use and counseling attendance were not significantly different between the groups. Alcohol and drug use did not change significantly in either group. Conclusions:Among homeless smokers, financial incentives increased brief smoking abstinence and quit attempts without worsening substance use. This approach merits further development focused on promoting sustained abstinence. Registration:ClinicalTrials.gov (NCT02565381). Implications:Smoking is common among homeless people, and conventional tobacco treatment strategies have yielded modest results in this population. This pilot RCT suggests that financial incentives may be a safe way to promote brief smoking abstinence and quit attempts in this vulnerable group of smokers. However, further development is necessary to translate this approach into real-world settings and to promote sustained periods of smoking abstinence.
Project description:Smoking cessation medications are routinely used in health care; it is vital to identify medications that most effectively treat this leading cause of preventable mortality.To compare the efficacies of varenicline, combination nicotine replacement therapy (C-NRT), and the nicotine patch for 26-week quit rates.Three-group randomized intention-to-treat clinical trial occurring from May 2012 to November 2015 among smokers recruited in the Madison, Wisconsin, and Milwaukee, Wisconsin, communities; 65.5% of smokers offered the study (2687/4102) refused participation prior to randomization.Participants were randomized to one of three 12-week open-label smoking cessation pharmacotherapy groups: (1) nicotine patch only (n?=?241); (2) varenicline only (including 1 prequit week; n?=?424); and (3) C-NRT (nicotine patch?+?nicotine lozenge; n?=?421). Six counseling sessions were offered.The primary outcome was carbon monoxide-confirmed self-reported 7-day point-prevalence abstinence at 26 weeks. Secondary outcomes were carbon monoxide-confirmed self-reported initial abstinence, prolonged abstinence at 26 weeks, and point-prevalence abstinence at weeks 4, 12, and 52.Among 1086 smokers randomized (52% women; 67% white; mean age, 48 years; mean of 17 cigarettes smoked per day), 917 (84%) provided 12-month follow-up data. Treatments did not differ on any abstinence outcome measure at 26 or 52 weeks, including point-prevalence abstinence at 26 weeks (nicotine patch, 22.8% [55/241]; varenicline, 23.6% [100/424]; and C-NRT, 26.8% [113/421]) or at 52 weeks (nicotine patch, 20.8% [50/241]; varenicline, 19.1% [81/424]; and C-NRT, 20.2% [85/421]). At 26 weeks, the risk differences for abstinence were, for patch vs varenicline, -0.76% (95% CI, -7.4% to 5.9%); for patch vs C-NRT, -4.0% (95% CI, -10.8% to 2.8%); and for varenicline vs C-NRT, -3.3% (95% CI, -9.1% to 2.6%). All medications were well tolerated, but varenicline produced more frequent adverse events than did the nicotine patch for vivid dreams, insomnia, nausea, constipation, sleepiness, and indigestion.Among adults motivated to quit smoking, 12 weeks of open-label treatment with nicotine patch, varenicline, or C-NRT produced no significant differences in biochemically confirmed rates of smoking abstinence at 26 weeks. The results raise questions about the relative effectiveness of intense smoking pharmacotherapies.clinicaltrials.gov Identifier: NCT01553084.
Project description:BACKGROUND:Smoking reduction treatment is a promising approach to increase abstinence amongst smokers initially unwilling to quit. However, little is known about which reduction treatment elements increase quit attempts and the uptake of cessation treatment amongst such smokers. METHODS:This study is a secondary analysis of a 4-factor randomized factorial experiment conducted amongst primary care patients (N?=?517) presenting for regular healthcare visits in Southern Wisconsin who were unwilling to quit smoking but willing to cut down. We evaluated the main and interactive effects of Motivation-phase intervention components on whether participants: 1) made a quit attempt (intentional abstinence ?24?h) by 6- and 26-weeks post-study enrollment and, 2) used cessation treatment. We also evaluated the relations of quit attempts with abstinence. The four intervention components evaluated were: 1) Nicotine Patch vs. None; 2) Nicotine Gum vs. None; 3) Motivational Interviewing (MI) vs. None; and 4) Behavioral Reduction Counseling (BR) vs. None. Intervention components were administered over 6 weeks, with an option to repeat treatment; participants could request cessation treatment at any point. RESULTS:Nicotine gum significantly increased the likelihood of making a quit attempt by 6 weeks (23% vs. 15% without gum; p?<?.05). Conversely, nicotine patch reduced quit attempts when used with BR. Patch also discouraged use of cessation treatment (15.8% vs. 23% without patch; p?<?.05). Aided vs. unaided quit attempts produced abstinence in 42% vs. 10% of participants, respectively. CONCLUSION:Nicotine gum is a promising Motivation-phase intervention that may spur quit attempts amongst smokers initially unwilling to quit.
Project description:BACKGROUND:Homeless smokers want to quit smoking but face numerous barriers to doing so, including pervasive smoking among peers and a lack of social support for quitting. An SMS (short message service) text messaging intervention could address these challenges by providing virtual daily support for homeless smokers who are trying to quit but coping with multiple triggers to smoke. OBJECTIVE:This study aimed to assess whether a free SMS text messaging program, added to evidence-based pharmacotherapy and counseling, improved smoking abstinence among homeless adult smokers. METHODS:From October 2015 to June 2016, we conducted an 8-week pilot randomized controlled trial (RCT) of nicotine patch therapy and weekly in-person counseling with (n=25) or without (n=25) SmokefreeTXT, a free SMS text messaging service administered by the National Cancer Institute (NCI) at Boston Health Care for the Homeless Program. All participants were provided with a mobile phone and a 2-month prepaid voice and text plan at no cost. SmokefreeTXT enrollees were sent 1 to 5 automated SMS text messages daily for up to 8 weeks and could receive on-demand tips for managing cravings, mood symptoms, and smoking lapses. The primary outcome was smoking abstinence, defined as an exhaled carbon monoxide count of <8 parts per million, assessed 14 times over 8 weeks of follow-up, and analyzed using repeated-measures logistic regression with generalized estimating equations. Other outcomes were use of SmokefreeTXT, assessed by data obtained from NCI; perceptions of SmokefreeTXT, assessed by surveys and qualitative interviews; and mobile phone retention, assessed by self-report. RESULTS:Of the SmokefreeTXT arm participants (n=25), 88% (22) enrolled in the program, but only 56% (14) had confirmed enrollment for ?2 weeks. Among 2-week enrollees, the median response rate to interactive messages from SmokefreeTXT was 2.1% (interquartile range 0-10.5%). Across all time points, smoking abstinence did not differ significantly between SmokefreeTXT and control arm participants (odds ratio 0.92, 95% CI 0.30-2.84). Of SmokefreeTXT enrollees who completed exit surveys (n=15), two-thirds were very or extremely satisfied with the program. However, qualitative interviews (n=14) revealed that many participants preferred in-person intervention formats over phone-based, found the SMS text messages impersonal and robotic, and felt that the messages were too frequent and repetitive. Only 40% (10/25) of SmokefreeTXT arm participants retained their study-supplied mobile phone for the 8-week duration of the trial, with phone theft being common. Storing and charging phones were cited as challenges. CONCLUSIONS:SmokefreeTXT, added to nicotine patch therapy and in-person counseling, did not significantly improve smoking abstinence in this 8-week pilot RCT for homeless smokers. SMS text messaging interventions for this population should be better tuned to the unique circumstances of homelessness and coupled with efforts to promote mobile phone retention over time. TRIAL REGISTRATION:ClinicalTrials.gov NCT02565381; https://clinicaltrials.gov/ct2/show/NCT02565381 (Archived by WebCite at http://www.webcitation.org/78PLpDptZ).
Project description:BACKGROUND:Understanding how smoking cessation treatments exert their effects can inform treatment development and use. Factorial designs allow researchers to examine whether multiple intervention components affect hypothesized change mechanisms, and whether the affected mechanisms are related to cessation. METHODS:This is a secondary data analysis of smokers recruited during primary care visits (N=637, 55% women, 87% white) who were motivated to quit. Participants in this fractional factorial experiment were randomized to one level of each of six intervention factors: Prequit Nicotine Patch vs None, Prequit Nicotine Gum vs None, Preparation Counseling vs None, Intensive In-Person Counseling vs Minimal, Intensive Phone Counseling vs Minimal, and 16 vs 8 Weeks of Combination Nicotine Replacement (nicotine patch+nicotine gum). Data on putative mechanisms (e.g., medication use, withdrawal, self-efficacy) and smoking status were gathered using daily assessments and during follow-up assessment calls. RESULTS:Some intervention components influenced hypothesized mechanisms. Prequit Gum and Patch each reduced prequit smoking and enhanced prequit coping and self-efficacy. In-Person Counseling increased prequit motivation to quit, postquit self-efficacy, and postquit perceived intratreatment support. Withdrawal reduction and reduced prequit smoking produced the strongest effects on cessation. The significant effect of combining Prequit Gum and In-Person Counseling on 26-week abstinence was mediated by increased prequit self-efficacy. CONCLUSIONS:This factorial experiment identified which putative treatment mechanisms were influenced by discrete intervention components and which mechanisms influenced cessation. Such information supports the combined use of prequit nicotine gum and intensive in-person counseling as cessation interventions that operate via increased prequit self-efficacy.
Project description:To identify promising intervention components intended to help smokers to attain and maintain abstinence in their quit smoking attempts.A fully crossed, six-factor randomized fractional factorial experiment.Eleven primary care clinics in southern Wisconsin, USA.A total of 637 adult smokers (55% women, 88% white) motivated to quit smoking who visited primary care clinics.Six intervention components designed to prepare smokers to quit, and achieve and maintain abstinence (i.e. for the preparation, cessation and maintenance phases of smoking treatment): (1) preparation nicotine patch versus none; (2) preparation nicotine gum versus none; (3) preparation counseling versus none; (4) intensive cessation in-person counseling versus minimal; (5) intensive cessation telephone counseling versus minimal; and (6) 16 versus 8?weeks of combination nicotine replacement therapy (nicotine patch ?+? nicotine gum).Seven-day self-reported point-prevalence abstinence at 16?weeks.Preparation counseling significantly improved week 16 abstinence rates (P = .04), while both forms of preparation nicotine replacement therapy interacted synergistically with intensive cessation in-person counseling (P?<?0.05). Conversely, intensive cessation phone counseling and intensive cessation in-person counseling interacted antagonistically (P?<?0.05)-these components produced higher abstinence rates by themselves than in combination.Preparation counseling and the combination of intensive cessation in-person counseling with preparation nicotine gum or patch are promising intervention components for smoking and should be evaluated as an integrated treatment package.