JOURNAL TRANSCRIPT
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
Acknowledgements Funding NIDA
Collaborators
Research Team
Tony Alberg, PhD
Amy Boatright
R01DA021619
Marvella Ford, PhD
R01CA154992
Kevin Gray, MD
Liz Byrd
K23DA020482
John Hughes, MD
Kathleen Cartmell, MPH
Mike Saladin, PhD
Dakota Hadley
Prevent Cancer Foundation American Cancer Society IRG-97219-08 Hollings Cancer Center
Gerard Silvestri, MD
Michelle Byczkiewicz
Katherine Ryan Nicola Thornley Amy Wahlquist, MS
Disclosures (past 3 years): Grant review/consultant: NIH, UMinn, Wash U., FL Dept Health
Incidence of 24hr Quit Attempts 1 0.9 0.8
Not Yet Ready to Quit
0.7 0.6 0.5 0.4 0.3
Ready to Quit
0.2
0.1 0 1997
1998
1999
2000
2001
2002
2003
Source: www.cdc.gov/tobacco/research_data/mmwr.htm
2004
2005
2006
2007
2008
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
Cessation Induction Policy Interventions:
Taxation Smokefree legislation Health warning labels insurance premiums
Clinical Interventions:
Stage of change- based interventions Motivational interviewing (MI) Physician delivered advice to quit Behavioral strategies to induce cessation
Novel Behavioral Interventions for Cessation Induction? I. Smoking Reduction II. Medication Sampling
III. Feedback of Genetic Risk IV. PREPs? V. Contingency Management
Archives of Internal Medicine 2011; 171:1901-1907
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)
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
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”
Non-Cessation Arm: RCT of NRT Sampling 849 Enrolled Participants 423 Practice Quit Attempt (PQA)
426 PQA + NRT
Week -6 Week -3
Week -6 Treatment Period
Week -3
Week 0
Week 0
Week 4
Week 4
Week 12
Follow-Up Period Assessment Only
Week 24
Week 12 Week 24
Potential Mediators: ↑ Self-Efficacy ↑ Familiarity w/ Cessation Aids ↑ Social Support
Final Assessment at Six Months
Demographics % Female % Caucasian Age (SD) % College graduate Smoking History FTND Age began smoking Cigs/Day (weekday) % >1 prior quit attempt % >1 prior quit attempt in past 6 mo. % Live with smoker Motivation to quit in next month (0-10) Confidence to quit (0-10)
PQA (n=423) 66% 88% 50.7 (11.4) 28%
PQA+NRT (n=426) 62% 88% 50.5 (11.8) 26%
4.9 (2.0) 18.2 (9.2) 20.1 (8.5) 83% 14% 47% 2.7 (2.9) 3.9 (2.9)
4.7 (2.1) 17.4 (4.8) 19.6 (11.3) 83% 15% 43% 2.4 (2.8) 4.0 (3.0)
Percent
100 90 80 70 60 50 40 30 20 10 0
PQA only PQA + NRT OR=1.5 (95% CI: 1.1 – 1.9)
OR=1.5 (95% CI: 1.1 – 2.0) OR=1.6 (95% CI: 1.2 – 2.2) OR=1.4 (95% CI: 1.0 – 2.0)
Any QA
Any 24hr QA
Any 72hr QA
at any point in study * Abstinence: 7 day point prevalence (self report)
Abstinent*
OR=1.2 (95% CI: 0.8 – 1.8)
Abstinent*
at 6 months
100 90 80 70 60 50 40 30 20 10 0
6-wk Treatment Period
Percent
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
“Since we last spoke”
Use of ANY Tx
NRT Sampling: Intent to quit (0-10) 10
PQA - 1 month
PQA - 6 months
PQA + NRT - 1 month
PQA + NRT - 6 months
8 6 Time x Group: n.s.
Time x Group: p