Clinical Interventions to Promote Quit Attempts:

Transcription

1 Clinical Interventions to Promote Quit Attempts: Treatment Development and Dissemination Matthew Carpenter, PhD Department of Psychiatry & Behavioral Sciences Hollings Cancer Center Medical University of South Carolina March, 2012

2 Acknowledgements Funding NIDA R01DA R01CA K23DA Prevent Cancer Foundation American Cancer Society IRG Hollings Cancer Center Collaborators Tony Alberg, PhD Marvella Ford, PhD Kevin Gray, MD John Hughes, MD Mike Saladin, PhD Gerard Silvestri, MD Research Team Amy Boatright Michelle Byczkiewicz Liz Byrd Kathleen Cartmell, MPH Dakota Hadley Katherine Ryan Nicola Thornley Amy Wahlquist, MS Disclosures (past 3 years): Grant review/consultant: NIH, UMinn, Wash U., FL Dept Health

3 Incidence of 24hr Quit Attempts Not Yet Ready to Quit Ready to Quit Source:

4 The Rest of the Pack: Cessation Induction Focus on unmotivated smokers, who are the majority: ~ 60% of smokers do not make a quit attempt in a given year ~ 75-80% of smokers uninterested in quitting in next 30 days Intended outcomes: induce motivation Induce confidence induce quit attempts induce abstinence

5 Policy Interventions: Taxation Smokefree legislation Health warning labels insurance premiums Clinical Interventions: Cessation Induction Stage of change- based interventions Motivational interviewing (MI) Physician delivered advice to quit Behavioral strategies to induce cessation

6 Novel Behavioral Interventions for Cessation Induction? I. Smoking Reduction II. Medication Sampling III. Feedback of Genetic Risk IV. PREPs? V. Contingency Management

7 Archives of Internal Medicine 2011; 171:

8 Aims and Design Principal Aim: Determine whether adding free NRT to brief advice to undertake a practice quit attempt will motivate more smokers to 1) make subsequent quit attempts and, 2) quit, than would brief advice without NRT Method: A large, randomized, controlled clinical trial testing: 1) PQA ONLY: Practice Quit Attempts (PQA) aided by brief advice and self-help materials 2) NRT Sampling: PQA aided by advice and self-help materials plus NRT A population-based sample of unmotivated, NRT-naïve smokers recruited through online channels. All treatments & assessments delivered via telephone / mailing. Outcomes: Further quit attempts, cessation, use of pharmacotherapy, increases in (mediators) self-efficacy, social support, familiarization with NRT Main Hypothesis: NRT sampling will serve as cessation induction (increases in each of above outcomes)

9 Practice Quit Attempt - short period (hours, days) of sampling abstinence - remove stress of trying to quit for good - learn coping behaviors - what works, what doesn t PQA + NRT - same as above - sample NRT - learn how it works, what it does, what it doesn t do, etc - NRT nicotine lozenge: OTC, prn dosing, minimal side effects Theory: PQA, particularly when combined with NRT, is a chance to 1) Self-Efficacy, 2) Familiarity w/ Cessation Aids, 3) Social Support, 4) Distress/Withdrawal

10 Increased Motivation & Efficacy to Quit This isn t so bad, I can do this Increased Familiarity / Improved Attitudes towards Medication I didn t know these things worked I thought I was going to get addicted to these Increased Social Support Nice to get some encouragement for trying

11 Non-Cessation Arm: RCT of NRT Sampling 849 Enrolled Participants 423 Practice Quit Attempt (PQA) 426 PQA + NRT Week -6 Week -3 Week 0 Week 4 Week 12 Week 24 Treatment Period Follow-Up Period Assessment Only Potential Mediators: Self-Efficacy Familiarity w/ Cessation Aids Social Support Week -6 Week -3 Week 0 Week 4 Week 12 Week 24 Final Assessment at Six Months

12 PQA PQA+NRT Demographics (n=423) (n=426) % Female 66% 62% % Caucasian 88% 88% Age (SD) 50.7 (11.4) 50.5 (11.8) % College graduate 28% 26% Smoking History FTND 4.9 (2.0) 4.7 (2.1) Age began smoking 18.2 (9.2) 17.4 (4.8) Cigs/Day (weekday) 20.1 (8.5) 19.6 (11.3) % >1 prior quit attempt 83% 83% % >1 prior quit attempt in past 6 mo. 14% 15% % Live with smoker 47% 43% Motivation to quit in next month (0-10) 2.7 (2.9) 2.4 (2.8) Confidence to quit (0-10) 3.9 (2.9) 4.0 (3.0)

13 Percent OR=1.5 (95% CI: ) OR=1.5 (95% CI: ) OR=1.6 (95% CI: ) PQA only PQA + NRT OR=1.4 (95% CI: ) OR=1.2 (95% CI: ) Any QA Any 24hr QA Any 72hr QA Abstinent* Abstinent* at any point in study at 6 months * Abstinence: 7 day point prevalence (self report)

14 Percent wk Treatment Period 6-mnth follow-up period PQA/NRT PQA only PQA/NRT PQA only PQA/NRT PQA only PQA/NRT PQA only Use of Any Med Use of Any Medication Except Lozenge (sample) Use of Behavioral Tx Use of ANY Tx Since we last spoke

15 NRT Sampling: Intent to quit (0-10) 10 8 PQA - 1 month PQA + NRT - 1 month PQA - 6 months PQA + NRT - 6 months 6 4 Time x Group: p<.001 Time x Group: n.s. 2 0 Intervention period Follow-up period Week -6 Week -3 Week 0 Week 4 Week 12 Week 26

16 NRT Sampling: Confidence to Quit (0-10) 10 8 PQA PQA + NRT 6 4 Time x Group: p =.001 Time x Group: n.s. 2 0 Intervention period Follow-up period Week -6 Week -3 Week 0 Week 4 Week 12 Week 26

17 Mean 4 NRT Sampling: Attitudes Toward NRT (1-4) Positive Attitudes Toward NRT PQA/NRT Positive Attitudes Toward NRT PQA only Negative Attitudes Toward NRT PQA/NRT Negative Attitudes Toward NRT PQA only Time x Group: p<.01 Baseline Week0 Week 26

18 Sum NRT Sampling: Knowledge of NRT (0-10) 10 8 PQA/NRT PQA only Time x Group: p<.001 Baseline Week0 Week 26

19 Conclusions: NRT Sampling For smokers unmotivated to quit- Brief sampling of NRT, combined with the behavioral exercise of a Practice Quit Attempt can promote: Knowledge of evidence based treatment Motivation & Confidence to Quit Quit Attempts & Cessation Effects comparable to other persuasion-based cessation induction methods OR for Abstinence NRT Sampling 1.4 Physician Advice 1.3 USPHS 2008 Physician Advice 1.6 Cochrane Motivational Interviewing 1.3 Cochrane

20 Proactive Recruitment / Enrollment Why: reach ALL smokers, not just those ready to quit now How: 1. RDD 2. Online channels 3. EMR 4. HMO 5. Employee-Assistance Programs 6. Social networking Ex: Carpenter 2004, 2010, 2011; Tzelepis 2009, 2011; Velicer 2006 Ex: Murray 2008; Velicer 2006; Gilbert 2007 Ex: Bastian 2011

21 Benefits: - Reach large numbers of individuals, and thus large numbers of smokers - Can be fairly automated - Reach individuals (demographic groups) who typically do not seek out cessation Drawbacks: - Costly - Inefficient? Low yield of (# enrolled) / (# screened) - Digital divide? - Cell-phone only households / do not call lists - HIPAA / privacy concerns

22 Process Identify Smokers Brief Eligibility Screen Study Invite & Consent Opt in vs. opt out? Paper Consent? Mail NRT 1-2 wks OTC NRT multiple products? adjunctive instructions? Follow- Up Outcomes (to name a few) Reach Acceptability Cost effectiveness Use of quit resources Quit Attempts Abstinence

23 QUESTIONS Matthew Carpenter, PhD