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Pharmacogenetic smoking cessation intervention in a health care setting: a pilot feasibility study.

ABSTRACT: There is increasing evidence that response to pharmacological treatment for nicotine dependence may be moderated by genetic polymorphisms. However, the feasibility, acceptability, and impact of genetically tailoring treatment in real-world clinical settings are unknown.We conducted a multiphased, mixed-methods feasibility study with current smokers to develop and evaluate a patient-centered, theoretically grounded personalized medicine treatment protocol. The initial research phase included formative work to develop intervention materials. The second phase included a randomized pilot trial to evaluate the intervention. Trial participants (n = 36) were genotyped for ANKK1 rs1800497 and were randomized to receive genetic feedback (GF) plus standard behavioral counseling (BC) for smoking cessation or BC without GF. All participants received genetically tailored pharmacotherapy (nicotine patch or bupropion).The intervention was feasible to implement and was acceptable to participants based on satisfaction ratings and objective measures of participation. There was no evidence that the GF resulted in adverse psychological outcomes (e.g., depression, fatalism, reduced perceived control over quitting, differential motivation for quitting) based on quantitative or qualitative outcomes.Study results suggest that it is feasible to offer treatment within a health care setting that includes genetically tailored pharmacotherapy and doing so had no apparent adverse psychological impacts. Further evaluation of pharmacogenetically tailored smoking cessation interventions appears warranted.

SUBMITTER: McClure JB

PROVIDER: S-EPMC3611995 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Pharmacogenetic smoking cessation intervention in a health care setting: a pilot feasibility study.

McClure Jennifer B JB Swan Gary E GE St John Jackie J Fauver Randy R Javitz Harold S HS Bergen Andrew W AW Nishita Denise D Niaura Raymond R Munafò Marcus R MR David Sean P SP

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20120904 2

<h4>Introduction</h4>There is increasing evidence that response to pharmacological treatment for nicotine dependence may be moderated by genetic polymorphisms. However, the feasibility, acceptability, and impact of genetically tailoring treatment in real-world clinical settings are unknown.<h4>Methods</h4>We conducted a multiphased, mixed-methods feasibility study with current smokers to develop and evaluate a patient-centered, theoretically grounded personalized medicine treatment protocol. The ...[more]

PMID: 22949583

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Project description:Access to effective smoking cessation programs is crucial to reducing smoking-related morbidity and mortality. Several studies have shown promising results for the application of Acceptance and Commitment Therapy (ACT) in managing psychological or behavioral health problems. However, to date, only one study has examined the feasibility of a telephone-based ACT for smoking cessation and it was conducted among a Western population, in the United States. This study reports a protocol for a randomized controlled trial (RCT) examining the feasibility and potential efficacy of an individual, telephone-delivered ACT for smoking cessation in primary healthcare settings among a Chinese population.A randomized, two-group design was chosen, with assessment at baseline (before intervention) and via telephone follow-ups at three and six months. Subjects will be proactively recruited from primary healthcare centers. Eligible participants will be randomized to either the intervention (ACT) or control group following the baseline assessment. Both groups will receive self-help materials on smoking cessation. Those in the ACT group will undergo an initial face-to-face session and two telephone ACT sessions at one week and one month following the first session, to be delivered by a counselor based on the treatment protocol. All of the participants will be contacted by telephone for follow-up assessments at three and six months. Treatment fidelity will be assessed by reviewing around one-fifth of audio-recorded telephone calls.To the best of our knowledge, this protocol describes the first RCT of a telephone-based ACT for smoking cessation. It is also the first RCT of ACT for smoking cessation on a Chinese population. The study will provide us with information about the feasibility of a telephone-delivered ACT within a Chinese sample. If effective, this trial will support the development of ACT treatment protocols that could be made available for use by a greater range of clinicians, and offer an evidence base to support alternative treatments for smoking cessation.ClinicalTrials.gov ID NCT01652508. Registered on 26(th) July 2012.

Project description:There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice.Multicentre randomized clinical trial with an intervention and a control group.12 primary care centres in the province of Tarragona (Spain).600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention.Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking.Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking.Smoking cessation at 12 months.Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker.Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group.Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care.ClinicalTrial.gov, number NCT01194596.

Project description:BackgroundMobile health (mHealth) interventions hold great promise for helping smokers quit since these programs can have wide reach and facilitate access to comprehensive, interactive, and adaptive treatment content. However, the feasibility, acceptability, and effectiveness of these programs remain largely untested.ObjectiveTo assess feasibility and acceptability of the My Mobile Advice Program (MyMAP) smoking cessation program and estimate its effects on smoking cessation and medication adherence to inform future research planning.MethodsSixty-six smokers ready to quit were recruited from a large regional health care system and randomized to one of two mHealth programs: (1) standard self-help including psychoeducational materials and guidance how to quit smoking or (2) an adaptive and interactive program consisting of the same standard mHealth self-help content as controls received plus a) real-time, adaptively tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor. Participants in both arms were also prescribed a 12-week course of varenicline. Follow-up assessments were conducted at 2 weeks post-target quit date (TQD), 3 months post-TQD, and 5 months post-TQD. Indices of program feasibility and acceptability included acceptability ratings, utilization metrics including use of each MyMAP program component (self-help content, secure messaging, and adaptively tailored advice), and open-ended feedback from participants. Smoking abstinence and medication adherence were also assessed to estimate effects on these treatment outcomes.ResultsUtilization data indicated the MyMAP program was actively used, with higher mean program log-ins by experimental than control participants (10.6 vs 2.7, P<.001). The majority of experimental respondents thought the MyMAP program could help other people quit smoking (22/24, 92%) and consistently take their stop-smoking medication (17/22, 97%) and would recommend the program to others (20/23, 87%). They also rated the program as convenient, responsive to their needs, and easy to use. Abstinence rates at 5-month follow-up were 36% in the experimental arm versus 24% among controls (odds ratio 1.79 [0.61-5.19], P=.42). Experimental participants used their varenicline an average of 46 days versus 39 among controls (P=.49). More than two-thirds (22/33, 67%) of experimental participants and three-quarters (25/33, 76%) of controls prematurely discontinued their varenicline use (P=.29).ConclusionsThe MyMAP intervention was found to be feasible and acceptable. Since the study was not powered for statistical significance, no conclusions can be drawn about the program's effects on smoking abstinence or medication adherence, but the overall study results suggest further evaluation in a larger randomized trial is warranted.ClinicaltrialClinicalTrials.gov NCT02136498; https://clinicaltrials.gov/ct2/show/NCT02136498 (Archived by WebCite at http://www.webcitation.org/6jT3UMFLj).

Project description:Introduction:Varenicline doubles cessation over nicotine replacement therapy (NRT) patch for "normal," but not "slow," nicotine metabolizers, as assessed by the nicotine metabolite ratio (NMR). Metabolism-informed care (MIC) could improve outcomes by matching normal metabolizers with non-nicotine medication (e.g., varenicline) and slow metabolizers with NRT patch. Methods:We conducted a feasibility randomized controlled trial of MIC versus guideline based care (GBC) among 81 outpatient adult daily smokers with medical comorbidity. Participants reported perceptions of MIC, underwent blood draw for NMR, and received expert cessation counseling. For MIC participants, medication selection was informed by NMR result (normal (?0.31) vs. slow (< 0.31)). The primary outcome was MIC feasibility, reflected by attitudes toward MIC and by match rates between NMR and medication. Secondary endpoints (cessation confidence, medication use, smoking status) were assessed over 6 months to inform future studies. Results:Participants were median age 53 years, 46% female, 28% black, and ~90% endorsed MIC. Despite high varenicline prescription rates (~60%) in both arms, NMR-medication matching was higher in MIC (84%) versus GBC (58%) participants (p=0.02); unadjusted odds ratio (OR) 3.67, 95% confidence interval [1.33, 11.00; p-value=0.02]. Secondary endpoints were similar at 1, 3, and 6 months. Conclusions:MIC, an NMR-based precision approach to smoking cessation, was acceptable to 90% of smokers and improved NMR-medication match rates more than 3-fold compared to GBC, even with generally high use of varenicline. These data support the feasibility of MIC, which could maximize efficacy of smoking cessation medication while minimizing side effects and cost. Implications:Among treatment-seeking daily smokers with medical comorbidity, most viewed metabolism-informed care (MIC), guided by the nicotine metabolism ratio (NMR), favorably, and were willing to accept MIC-guided medication. Compared to GBC participants (58%), more MIC participants (84%) were prescribed NMR-matched medication (i.e., normal metabolizers received varenicline; slow metabolizers received NRT patch). MIC increased the odds of optimized matching between NMR and medication more than 3-fold over GBC. Because the number needed to treat (NNT) to help one normal metabolizer quit smoking is only 4.9 for varenicline versus 26 for patch, broad implementation of MIC will improve drug efficacy in normal metabolizers as well as minimize side effects in slow metabolizers.

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Pharmacogenetic smoking cessation intervention in a health care setting: a pilot feasibility study.

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Pharmacogenetic smoking cessation intervention in a health care setting: a pilot feasibility study.

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