Caffeine Dependence & Family History of

Alcoholism Predict Continued Use of

Caffeine During Pregnancy

Dace S. Svikis, Ph.D.Virginia Commonwealth

UniversityRichmond, Virginia

NIDA-ODS SymposiumJuly 8, 2009Bethesda, MD

Acknowledgments

Collaborators:Roland Griffiths, Ph.D.Nathan Berger, M.D.Nancy Haug, Ph.D.

Johns Hopkins Univ., School of MedicineBaltimore, MD

Funding: NIDA and NIAAA

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

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)

Current ACOG Recommendatio

ns(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.”

Cochrane Review July, 2009

Obstetrics 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

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

Cochrane Review Recommendations

• Only one RCT publishedBech 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

Birth of aResearch

Study• 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

1995

(over coffee?)

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

Study Design

(Parts 1 and 2) PART 1

Recruitment(1st PN Visit)

Baseline Survey &

Saliva

PART 1 Recruitment(1st PN Visit)

Baseline Survey &

Saliva

Physician

Advice:1st PN Visit

Eliminate Prenatal Caffeine

Use

Physician

Advice:1st PN Visit

Eliminate Prenatal Caffeine

Use

Follow-up #1(2nd PN Visit)

Survey + Saliva

Follow-up #1(2nd PN Visit)

Survey + Saliva

PART 2Recruitment between PN visits 2 and 6

(via telephone by memberof Research

Staff)

PART 2Recruitment between PN visits 2 and 6

(via telephone by memberof Research

Staff)

Follow-up #2(6th PN Visit)

Survey + Saliva

Follow-up #2(6th PN Visit)

Survey + Saliva

Personal Interview

SCID+ Caffeine

Dep. (DSM-IV)

FADS($50)

Personal Interview

SCID+ Caffeine

Dep. (DSM-IV)

FADS($50)

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

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.

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)

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)

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

Demographics

Variable Category Value

Age (years) Mean (SD) 31.9 (4.0)

Race (%) Caucasian 96%

African American 4%

Marital Status (%)

Married 100%

Education (%) Bachelor’s Degree

50%

Advanced Degree

23%

Employment (%) Full-time (>35 hrs/wk)

73%

Part-time 23%

Caffeine Dependence (application of DSM-IV

criteria)

Variable Value

Caffeine Dependence (lifetime)

57%

Tolerance 50%

Withdrawal 77%

Larger amounts/Longer time periods

45%

Desire/unsuccessful efforts to stop or control use

45%

Much time spent getting/using 25%

Give up activities to use 0%

Continued use despite problem 43%

Family History of Alcoholism

Relative Percent Positive

Biological Father 32%

Biological Mother 14%

At Least One Parent 34%

At least one Sibling 39%

At least one first degree relative (FHP)

52%

Caffeine Use During Pregnancy

(N=44)

mg

s /

wee

k

**

* OB Intervention

Weekly Caffeine Consumption (Thinking by the cup… or the

can…)

Visit

CaffeineConsumed

(mgs/week)

BrewedCoffee

Cup Equivalent

s

SodaCan

Equiva-lents

Pre-Pregnanc

y

1,676 mgs

18-19 cups

45-50 cans

1st PN visit

564 mgs 6-7 cups15-16 cans

2nd PN visit

367 mgs 4-5 cups10-11 cans

6th PN visit

512 mgs 5-6 cups13-14 cans

Forms of Caffeine Consumption

(7 days before PN Visit #1)

25% Brewed/Regular Coffee 4%Instant Coffee28% Regular Tea13%Instant Tea30% Soft Drinks

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

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

Participant Fidelity Measures (First Follow-Up)

Question Percent Endorseme

nt

Physician advised them to stop using caffeine

75%

Received Written Materials 51%

Read Written Materials 45%

Attempted to Stop Caffeine Use

71%

Attempted to Cut Down on Use

65%

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.

Caffeine Use and Diagnosis of Caffeine

Dependence (CD)

* *

N.S. p<.008 N.S. p<.02

mg

/we

ek

Caffeine Use byFamily History of

Alcoholism

* *

p<.02 p<.05 N.S. p<.04

*

* *

mg

/we

ek

Family History of Alcoholism and DSM-IV

Caffeine Dep.

Family History

Alcoholism

Caffeine Dependenc

ePercent

SampleSize(N)

No No 23% 10

No Yes 25% 11

Yes No 20% 9

Yes Yes 32% 14

Caffeine Use by Family History and

Caffeine Dependence

mg

s/w

ee

k

*

100 mgs+ Caffeine per Day

StudyGroup2

Pre-Preg

1st PNVisit

2nd PNVisit

3rd PN Visit

FHN/CD- 71% 0% 0% 0%

FHP/CD- 73% 27% 9% 18%

FHN/CD+ 73% 20% 13% 27%

FHP/CD+

93% 71% 50% 64%

StudyGroup2

Pre-Preg

1st PNVisit

2nd PNVisit

3rd PN Visit

FHN/CD- 57% 0% 0% 0%

FHP/CD- 55% 18% 9% 0%

FHN/CD+ 27% 7% 7% 7%

FHP/CD+

71% 43% 14% 29%

300 mgs+ Caffeine per Day

NOTE:Physician

advice occursat 1st PN

visit

Caffeine Abstinence During Pregnancy

Perc

en

t A

bsti

nen

t

Patterns of Prenatal Caffeine

Use

Caffeine Abstinence by Family

History of Alcoholism

Pe

rce

nt

Ab

sti

ne

nt

*

N.S.(.059)

.03 .03

*

Daily Smoking (Lifetime)by Family History and Caffeine Dependence

Per

cent

p<.001

Only 8.3% of women reported prenatal smoking

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

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

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”

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)