Contingency Management to Promote Smoking Cessation and Prevent Relapse Among Pregnant Women. Acknowledgements

Transcription

1 Contingency Management to Promote Smoking Cessation and Prevent Relapse Among Pregnant Women Sarah H. Heil, Ph.D. Substance Abuse Treatment Center Departments of Psychiatry and Psychology University of Vermont College of Medicine Burlington, VT National Conference on Women, Addiction and Recovery: News You Can Use July 2006 Acknowledgements Co-investigators: Stephen Higgins, Ph.D., PI Laura Solomon, Ph.D. Ira Bernstein, M.D. Fellows: Jin Yoon, Ph.D. Jen Lussier, Ph.D. Staff: Mary Ellen Lynch, R.N., Rebecca Abel, B.A., Ali Dumeer, B.A., Luke McHale, B.A., Lauren Shapiro, B.A., Paula Glassman, B.A., Lindsay Simpson, B.A. University of Vermont 2 Page 1

2 Smoking During Pregnancy Smoking is the leading preventable cause of poor pregnancy outcomes in U.S. Approximately 18% of pregnant women in U.S. report recent cigarette smoking compared to 10% for alcohol use and 4% for illicit drug use. University of Vermont 3 Adverse Effects Prenatally: Spontaneous abortions Fetal demise Fetal growth retardation Premature rupture of membranes Premature delivery Placental abruption Placental previa Postnatally: SIDS Low birth weight Upper respiratory problems Otitis media Hyperviscosity Behavior problems Burn/fire deaths University of Vermont 4 Page 2

3 Surgeon General s Report Eliminating smoking during pregnancy in the U.S. could prevent: 20% of low birth weight deliveries 8% of preterm deliveries 5% of perinatal deaths If smoking cessation is achieved before 16 weeks EGA, most of adverse effects are avoided. University of Vermont 5 Smoking Cessation Interventions Approximately 20 controlled trials in the literature; most based on public-health approach of low-cost, wide-reach interventions Examples: Brief advice from health-care providers; pregnancy-specific self-help materials; feedback regarding biochemical measures; telephone and in-person counseling; peer support Some are efficacious but quit rates are consistently below 20%, especially among lower-ses women University of Vermont 6 Page 3

4 How Do You Treat Pregnant Women Who Smoke? Best practice: The 5 A s (Melvin et al., 2000) ASK the woman about her smoking status ADVISE her to quit using clear, strong and personalized messages ASSESS her willingness to make a quit attempt within the next 30 days ASSIST her with ways to quit ARRANGE follow-up contacts with her to assess her smoking status University of Vermont 7 The 5 A s: Ask, Advise, Assess, Assist, & Arrange Virtual Clinic: Smoking Cessation for Pregnancy and Beyond. Developed by the Interactive Media Laboratory of Dartmouth Medical School. This interactive Virtual Clinic presents best practices for assisting patients in quitting and introduces the "5 A s. Earn up to 5 CME credits. Available at "Smoking Cessation During Pregnancy: A Clinician's Guide to Helping Pregnant Women Quit Smoking." Developed by ACOG. This new educational program provides the background and tools necessary for clinicians to implement the "5 A's" in the office. Earn 3 CME credits. To order a single copy of the guide: smoking@acog.org. Include your name, affiliation, and mailing address with your request. University of Vermont 8 Page 4

5 The 5 A s: Ask, Advise, Assess, Assist, & Arrange Most likely to be effective with pregnant women who: Are light to moderate smokers (smoking 10 cpd) Have already cut down Higher SES (> HS ed, higher income) First pregnancy Early in the pregnancy University of Vermont 9 Alternative Strategies Adverse effects of smoking are dose-related; heavier smokers are least responsive to minimal interventions Likely to need multiple levels of intervention involving more intensive interventions as with other types of drug abuse/dependence Seminal study (Sexton & Hebel, 1984) used a relatively intensive intervention (individual counseling, home visits, self-help materials, follow-up calls); cessation rates were 32% vs. 7% and improved birth weights were noted University of Vermont 10 Page 5

6 Voucher-Based Contingency Management More than 65 controlled studies support the efficacy of voucher-based CM (Lussier et al., Addiction, 101, ). Seminal study in application to pregnant smokers: Donatelle et al. (2000). Tobacco Control, 9, iii67- iii69 Our group followed up: Higgins et al. (2004) Nicotine & Tobacco Research, 6, ; Heil et al., in preparation University of Vermont 11 Donatelle et al., 2000 Women randomized to usual-care (n=108) or voucher condition (n=112) Abstinent-contingent $50 voucher available monthly for pregnant smoker, and $50 for 1st and last months and $25 each month in between for significant other Contingency in effect through pregnancy and 2 months postpartum Quit rates: End-of-Antepartum, 32% vs. 9%; 8 weeks postpartum, 21% vs. 6% University of Vermont 12 Page 6

7 Vermont Studies Cessation intervention more intensive than Donatelle et al., 2000 Daily for initial 5 days (breath CO < 6 ppm). 2 X weekly for 4 weeks (urine cotinine < 80 ng/ml) 1 X weekly for 4 weeks Every other week until delivery 1 X weekly for 4 weeks postpartum 2 X monthly for 8 weeks, after which vouchers ended University of Vermont 13 Voucher Conditions Contingent-voucher condition (n=30) Voucher delivery contingent on biochemically-verified abstinence Voucher value $6.25, $1.25/negative specimen to max of $45.00, mean earnings = $ Non-contingent voucher condition (n=23) Vouchers delivered independent of smoking status. Voucher $11.50/visit AP and $20/visit PP, mean earnings = $311±138 University of Vermont 14 Page 7

8 Participant Characteristics Characteristics Contingent a Non-contingent a p value (n = 30) (n = 23) Demographics: ± Age (years) 22.8 ± ± % Caucasian Education (years) 11.7 ± ± % Private insurance % Married % 1st pregnancy Weeks pregnant at intake 15.6 ± ± Smoking History: Age started (years) 14.1 ± ± % living with other smoker(s) Cigs/day prepregnancy 23.3 ± ± Cigs/day in past 7 days 9.9 ± ± Intake CO (ppm) 12.5 ± ± Intake urinary cotinine (ng/ml) 1070 ± ± Smoking Attitudes: Amount want to quit b 3.9 ± ± Confidence to quit b 3.1 ± ± Intend to quit while pregnant c 4.5 ± ± Note: Values represent mean ± SD, unless otherwise specified. a Treatment groups are described in the text b Assessed by a four-point scale: 1 = none, 4 = a lot c Assessed by a five-point scale: 1 = definitely not, 5 = definitely University of Vermont 15 Abstinence Rates (S-R + biochemical verification) % Abstinent * Contingent (N=30) * Non-contingent (N=23) * End of AP 3 mo PP 6 mo PP (Higgins et al., 2004) University of Vermont 16 Page 8

9 Fully-Randomized Trial Methods largely same as pilot study 82 women entered: Contingent condition n=37 Non-contingent condition n=40 5 excluded due to fetal demise Only differences from pilot are in random assignment and exclusive reliance on urine cotinine (some use of salivary cotinine in pilot study) University of Vermont 17 Abstinence Rates (S-R + biochemical verification) % Abstinent Contingent (N=37) Non-contingent (N=40) End of AP 3 mo PP 6 mo PP (Heil et al., in preparation) University of Vermont 18 Page 9

10 Improving Outcomes Relationship Between Early Smoking Status & Long-Term Outcome For abstainers: 79% of women who meet cotinine criterion on 1st test are abstinent at end-of-ap assessment (approx 6 months later) 88% of women abstinent at end-of-ap assessment are negative on 1st cotinine test For smokers: Among those smoking on 1st cotinine test, 91% smoking at end-of-ap assessment 83% of those smoking at end-of-ap assessment were positive at 1st cotinine test University of Vermont 19 Relationship between smoking status in initial 2 weeks and end-of-ap (EOAP) smoking status among contingent-voucher condition participants Contingent (n=66) Time Period Smoking Status N % Smoking at EOAP p-value Odds Ratio (95% CI) Week 1 Smoking 45 82% (68, 92) < (6.6, 117.3) Abstinent 21 14% (3, 36) Week 2 Smoking 42 86% (71, 95) < (7.6, 119.0) Abstinent 24 17% (5, 37) Week 1 & 2 Smoking 48 79% (65, 90) < (6.0, 154.6) Abstinent 18 11% (1, 35) (Higgins et al., in press) University of Vermont 20 Page 10

11 Preventing Relapse in Spontaneous Quitters Approx. 20% of women who smoked cigarettes prior to conception quit on their own shortly after learning of the pregnancy When followed over time, 65-80% sustain abstinence through the pregnancy Despite such striking success at abstaining during pregnancy, most relapse by 6-months postpartum We have an ongoing trial to try to prevent relapse University of Vermont women randomized: Contingent condition n = 36 Relapse Prevention Trial Non-contingent condition n=36 4 women excluded due to fetal demise Contingent condition: $10 voucher delivered at 1st test; escalates at monthly AP test by $5/test to max = $45 where it remains except for resets following a positive; PP testing is weekly in wks 1-4 and then 2X monthly through 12 weeks when voucher program ends. Mean earnings = $ 471 Non-contingent condition: Fixed amount ($18/test AP,$33/test PP) independent of smoking status University of Vermont 22 Page 11

12 Abstinence Rates (S-R + biochemical verification) % Abstinent End of AP 3 mo PP 6 mo PP Contingent (N=35) Non-contingent (N=33) University of Vermont 23 Understanding the Problem Delay Discounting, a measure of impulsivity, may be related to postpartum relapse to cigarette smoking Examined if DD of hypothetical monetary rewards at study intake predicted smoking status at 6-months PP (approx. 1 year later) 48 women who participated in the Relapse Prevention trial (both contingent & non-contingent conditions) Selected because they completed DD at baseline and had reached 6-month PP assessment when this DD study was conducted University of Vermont 24 Page 12

13 Results Greater discounting was observed during the first assessment in clients that eventually began smoking again when compared to clients that did not relapse Clients that relapsed showed a greater increase in discounting when compared to those that did not relapse when discounting values were assessed across time University of Vermont D elay (years) Discounting (k*1000) Yoon et al., in preparation University of Vermont 26 Page 13

14 Keys for Contingency Management Key moderators of the efficacy of CM: - Immediacy of the reward - the sooner the better - Magnitude of the reward - size does matter Lussier et al., 2006 University of Vermont 27 Future Research Directions We are revising the reinforcement schedules for the cessation and relapse-prevention interventions to improve outcomes without increasing costs With the cessation intervention, the goal is to increase end-of-ap abstinence to 60% With the relapse-prevention intervention, the goal is to obtain a significant treatment effect PP University of Vermont 28 Page 14

15 Contingency Management in the Real World Cost of CM interventions often cited as a barrier to their dissemination Cost from two different sources: The incentives themselves Biochemical monitoring University of Vermont 29 Cost of Incentives Donatelle et al. (2000) All incentives for their smoking cessation intervention were purchased with funds donated by community agencies Amass & Kamien (2004) Maintained voucher programs by soliciting donations (~ $4,000 in goods and services/month) via direct mail campaigns in Toronto and LA) University of Vermont 30 Page 15

16 Biochemical Monitoring CO monitors: Range from about $500-$1000 each, but if treated with care, can last many years Cotinine testing: On-site urinalysis machine running enzyme immunoassay test Dip-strip tests manufactured by Nymox which are essentially the same type of assay as our machine Range from $5-10 per strip University of Vermont 31 Is It Really Worth It? U.S. national costs of smoking during pregnancy estimated at $704 per maternal smoker (MMWR, 2004) or $1,570 in 2006 dollars Conservative estimates limited to costs associated with initial neonatal hospital stay after delivery University of Vermont 32 Page 16

17 Conclusions CM has a substantive contribution to make to efforts to decrease smoking among pregnant women There is growing recognition of the need for more intensive and costly interventions to increase cessation rates, especially among heavier smokers University of Vermont 33 Conclusions The results thus far using voucher-based CM to promote cessation during pregnancy are severalfold better than with more conventional interventions. Relapse prevention results are less promising Further efficacy studies, analyses of impact on fetal/newborn health, and cost analyses will be important to determining the overall merits of the approach University of Vermont 34 Page 17

18 References Amass, L., & Kamein, J. (2004). A tale of two cities: Financing two voucher programs for substance abusers through community donations. Experimental and Clinical Psychopharmacology, 12, Donatelle, R.J. (2000). Randomised controlled trial using social support and financial incentives for high risk pregnant smokers: Significant other supporter (SOS ) program. Tobacco Control, 9, Suppl. 3, III67-III69. Higgins, S.T., et al. (2004). A pilot study on voucher-based incentives to promote abstinence from cigarette smoking during pregnancy and postpartum. Nicotine and Tobacco Research, 6, Higgins, S.T., et al. (in press) Smoking status in the initial weeks of quitting as a predictor of smokingcessation outcomes in pregnant women. Drug and Alcohol Dependence Lussier, J.P., et al. (2006). A meta-analysis of voucher-based reinforcement therapy for substance use disorders. Addiction. 101, Melvin, C.L., et al. (2000). Recommended cessation counseling for pregnant women who smoke: A review of the evidence. Tobacco Control, 9, Suppl. 3, III80-III84. MMWR (Morbidity and Mortality Weekly Report) (Oct. 8, 2004). State estimates of neonatal health-care costs associated with maternal smoking - United States, Center for Disease Control and Prevention, 53, Sexton, M., & Hebel, J.R. (1984). A clinical trial of change in maternal smoking and its effect on birth weight. JAMA, 251, University of Vermont 35 The views expressed in written conference materials or publications and by speakers and moderators at Department of Health and Human Servicessponsored conferences do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government. University of Vermont 36 Page 18