Caffeine Dependence & Family History of Alcoholism

1. Caffeine Dependence & Family History of Alcoholism Predict Continued Use of Caffeine During Pregnancy Dace S. Svikis, Ph.D. Virginia Commonwealth University Richmond, Virginia NIDA-ODS Symposium July 8, 2009 Bethesda, MD

2. Acknowledgments Collaborators: Roland Griffiths, Ph.D. Nathan Berger, M.D. Nancy Haug, Ph.D. Johns Hopkins Univ., School of Medicine Baltimore, MD Funding: NIDA and NIAAA

3. Outline • Brief synopsis of research on prenatal caffeine use and maternal/infant outcomes • Describe research study of caffeine use in pregnancy • Monitor response of pregnant women to brief practitioner advice to stop consuming caffeine • Explore variables that may predict change in caffeine use post-physician advice • Implications/Future directions

4. Caffeine and Pregnancy • Caffeine is most one of most frequently used psychoactive substances (Vink et al., 2009) • Research on risks associated with prenatal caffeine use has produced mixed results • UK Committee on Toxicity (2001) • Risk of low birthweight and spontaneous abortion increases with increasing maternal caffeine intake during pregnancy • Threshold level of caffeine intake (above which caffeine intake presents a risk to pregnancy) has not been determined • Prudent to assume caffeine intakes above 300 mg/day (4 cups of coffee) show association with low birth weight and spontaneous abortion (animal studies and epidemiological research)

5. Current ACOG Recommendations(2009) “You … may want to avoid or limit your caffeine intake during pregnancy. Although some studies suggest drinking three or more cups of coffee per day may increase the risk of miscarriage, there is no proof that caffeine causes miscarriage.”

6. Cochrane ReviewJuly, 2009Obstetrics and Gynecology • > 80 published observational studies focused on effects of caffeine during pregnancy • Results are “conflicting, controversial and rarely evidence-based” for: • Spontaneous abortion • Congenital abnormalities • Fetal growth restriction • Low birth weight • Preterm birth

7. Cochrane Review(continued) • “Prudent for pregnant women to reduce caffeine intake before conception and during pregnancy” • Gained support with population-based cohort study (Weng et al, 2008) • Association between levels of caffeine intake and risk of miscarriage • Similar study showed no effect of caffeine on miscarriage rate (Savitz et al., 2008) • Conclude: Additional population and epidemiologic studies are unlikely to resolve contradictory findings

8. Cochrane ReviewRecommendations • Only one RCT published Bech et al. (2007; BMJ) • Randomized double blind controlled trial • N=1207 pregnant women drinking at least 3 cups of coffee/day • Group 1: Caffeinated instant coffee (N=568) • Group 2: Decaffeinated instant coffee (N=629) • Difference in mean caffeine intake post-randomization was 182 mgs/day (2-3 cups of coffee) • Findings: moderate reduction in caffeine during second half of pregnancy had no effect on birth weight or EGA Conclusion: More RCTs are needed

9. Birth of aResearch Study 1995 • Roland Griffiths – caffeine-related research • Dace Svikis – prenatal use of heroin and cocaine (Center for Addiction and Pregnancy (CAP)) • We met….. to talk about caffeine • Finding a setting that would allow us to look at individual differences in ability to discontinue caffeine use (when given message it is important to stop) • Found common ground: PREGNANCY (over coffee?)

10. Purpose • To examine the effectiveness of a strong physician message to eliminate caffeine use during pregnancy on quantity and frequency of caffeine use • To examine whether caffeine dependence & family history of alcoholism are associated with continued prenatal caffeine use

11. Study Design(Parts 1 and 2) PART 1 Recruitment (1st PN Visit) Baseline Survey & Saliva Follow-up #2 (6th PN Visit) Survey + Saliva Physician Advice: 1st PN Visit Eliminate Prenatal Caffeine Use Follow-up #1 (2nd PN Visit) Survey + Saliva Personal Interview SCID + Caffeine Dep. (DSM-IV) FADS ($50) PART 2 Recruitment between PN visits 2 and 6 (via telephone by member of Research Staff)

12. Recruitment • Study Part 1: • Recruitment occurred in suburban OB clinic prior to first prenatal visit (while patient waited to see the physician) • Pregnant women consented to complete 3 questionnaires and provide 5 ml saliva samples (caffeine assay) • Baseline: demographics, general health and substance use (caffeine, tobacco, alcohol, other drugs) during 6 months prior to pregnancy and past 7 days • Follow-ups: (prenatal visits 2 and 6): changes in caffeine use since last visit and past 7 days

13. Caffeine Assessment Baseline questionnaire focused on: • Type of beverage (coffee (roasted/brewed;) coffee (instant); tea (bag/leaf); tea (instant); soft drinks; caffeine containing medications) • Number of servings • Serving size • Usual brand Size guidelines included the following: Small cup = 5 oz. Regular cup/small mug = 8 oz. Large mug = 12 oz. Regular can of soft drink = 12 oz. Regular bottle of soft drink = 16 oz.

14. Participants(Part 1) • N = 109 women approached in waiting area • N = 100 (92%) consented and completed baseline procedures (questionnaire + saliva sample) • N = 87 (87%) completed 2nd prenatal visit questionnaire (follow-up #1) • N = 84 (84%) completed 6th prenatal visit questionnaire (follow-up #2)

15. Recruitment(Part 2) • Part 1 Study participants (N=84) given opportunity to participate in personal interview between questionnaire follow-ups 1 and 2 • Contacted and scheduled by phone; offered $50 for time/effort • Interview measures: • Structured Clinical Interview (SCID) for Axis I (Research version) • DSM-IV criteria modified to focus on Caffeine • Family Alcohol and Drug Survey (FADS)

16. Participants(Part 2) • N= 65 (78%) consented to interview • N= 50 (77%) completed the interview* • N = 5 (10%) excluded because they reported no pre-pregnancy caffeine use • N = 1 (0.2%) excluded because she miscarried between follow-ups 1 and 2 FINAL INTERVIEW SAMPLE: N=44

17. Demographics

18. Caffeine Dependence (application of DSM-IV criteria)

19. Family History of Alcoholism

20. Caffeine Use During Pregnancy(N=44) mgs / week * *OB Intervention

21. WeeklyCaffeine Consumption (Thinking by the cup… or the can…)

22. Forms of Caffeine Consumption(7 days before PN Visit #1) 25% Brewed/Regular Coffee 4% Instant Coffee 28%Regular Tea 13% Instant Tea 30% Soft Drinks

23. Brief Physician Advice • Investigators met with Dr. Berger to discuss serving as research site • Reviewed data on caffeine use during pregnancy (at that time) • Dr. Berger felt comfortable summarizing potential risks of prenatal caffeine use and giving recommendation that women stop caffeine use for remainder of pregnancy • Written materials were also provided in the packet of handouts given to all pregnant women at first PN visit

24. Fidelity Monitoring • Research staff reminded Dr. Berger on regular basis • We monitored “take home” packets to make sure caffeine handout was included • Participants were surveyed at follow-up about receipt of physician message SECRET WEAPON: Marianne Berger

25. Participant Fidelity Measures (First Follow-Up)

26. Efforts to Change Caffeine Use Post-Physician Message • 98% of women reported at PN Visits 2 and 6 (via questionnaire) that they attempted to completely eliminate or cut back on prenatal caffeine use • 54% stated they experienced 1+ symptoms of caffeine withdrawal • 26% stated that withdrawal severity interfered with their responsibilities at work, home, school.

27. Caffeine Use and Diagnosis of Caffeine Dependence (CD) mg/week * * N.S. p<.008 N.S. p<.02

28. Caffeine Use by Family History of Alcoholism * mg/week * * * * p<.04 p<.02 p<.05 N.S.

29. Family History of Alcoholism and DSM-IV Caffeine Dep.

30. Caffeine Use by Family History and Caffeine Dependence mgs/week *

31. 100 mgs+ Caffeine per Day NOTE: Physician advice occurs at 1st PN visit 300 mgs+ Caffeine per Day

32. Caffeine Abstinence During Pregnancy Percent Abstinent

33. Patterns of Prenatal Caffeine Use

34. Caffeine Abstinence by Family History of Alcoholism * * Percent Abstinent N.S. (.059) .03 .03

35. Daily Smoking (Lifetime)by Family History and Caffeine Dependence p<.001 Percent Only 8.3% of women reported prenatal smoking

36. Summary • Over one-third of pregnant women spontaneously eliminated caffeine use at time of pregnancy awareness (with no clinic-based intervention) • One month following brief physician advice to abstain, nearly half of the women had eliminated caffeine use • Rates of abstinence four months later were intermediate, with approximately 40% of women reporting caffeine abstinence

37. Practice Implications • Patterns of caffeine use during pregnancy varied as a function of: DSM-IV Caffeine Dependence diagnosis (CD) and • Family History of Alcoholism (FHP) • FHP/CD+ women had higher levels of prenatal caffeine use (but did reduce caffeine use post-physician message) • Such women are at increased risk for other substance use (e.g., smoking) • Represent a unique target group for intervention and prevention efforts

38. Caffeine and Other Prenatal Drug Use • Patterns of caffeine use during pregnancy were similar to those found for other substances (e.g., alcohol) • Social stigma associated with prenatal caffeine use remains lower than that for alcohol, other drugs (and more recently: even tobacco) • Caffeine may be useful in future SBIRT research as “foot in the door”

39. Limitations • Small sample size • Homogeneous sample • Higher rate of infertility patients attending the clinic • Need for replication and extension to more diverse patient populations • Need for RCTs (to evaluate practitioner advice and other interventions)