Pre-clinical data show that estrogen increases the likelihood of stimulant self- administration;progesterone has the opposite effect and can reverse the effect of estradiol. Limited human data show that progesterone attenuates cravings for and subjective positive response to stimulants in women. Pregnancy, which is characterized by high circulating progesterone levels, is associated with decreased substance use. Unfortunately, drug use increases again after delivery. The incremental decrease in drug use over the course of pregnancy as progesterone levels increase, and the escalation in drug use after delivery when progesterone levels drop, suggests the possibility that progesterone influences drug use. This application seeks funding to obtain preliminary data on whether treatment with progesterone, which would counterbalance the progesterone lost with parturition, reduces cocaine use among postpartum women. Accordingly, we propose a double-blind, randomized, placebo-controlled trial that would obtain preliminary data on the efficacy of oral micronized progesterone for postpartum women with a history of cocaine dependence or abuse. We would randomize 50 postpartum women and evaluate them weekly for three months and then again 3 months after the end of the trial. Participants would also receive cognitive-behavioral counseling for drug use. Outcome measures include the percentage of days and amount of cocaine use during the trial for women randomized to one or the other of the two (placebo or progesterone) conditions.

Public Health Relevance

Pregnancy, which is characterized by high circulating progesterone levels, is associated with decreased substance use. This application seeks funding to obtain preliminary data on whether treatment with progesterone, which would counterbalance the progesterone lost with parturition, reduces cocaine use among postpartum women. Accordingly, we propose a double-blind, randomized, placebo- controlled trial that would obtain preliminary data on the efficacy of oral micronized progesterone for postpartum women with a history of cocaine dependence or abuse.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21DA029914-02
Application #
8133544
Study Section
Special Emphasis Panel (ZRG1-RPIA-K (09))
Program Officer
Walton, Kevin
Project Start
2010-09-01
Project End
2013-07-31
Budget Start
2011-08-01
Budget End
2013-07-31
Support Year
2
Fiscal Year
2011
Total Cost
$240,803
Indirect Cost
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Smith, Megan V; Costello, Darce; Yonkers, Kimberly A (2015) Clinical correlates of prescription opioid analgesic use in pregnancy. Matern Child Health J 19:548-56
Cole-Lewis, Heather J; Kershaw, Trace S; Earnshaw, Valerie A et al. (2014) Pregnancy-specific stress, preterm birth, and gestational age among high-risk young women. Health Psychol 33:1033-45
Forray, Ariadna; Gotman, Nathan; Kershaw, Trace et al. (2014) Perinatal smoking and depression in women with concurrent substance use. Addict Behav 39:749-56
Yonkers, Kimberly Ann; Forray, Ariadna; Nich, Charla et al. (2014) Progesterone Reduces Cocaine Use in Postpartum Women with a Cocaine Use Disorder: A Randomized,Double-Blind Study. Lancet Psychiatry 1:360-367
Yonkers, Kimberly A; Blackwell, Katherine A; Glover, Janis et al. (2014) Antidepressant use in pregnant and postpartum women. Annu Rev Clin Psychol 10:369-92
Xu, Xiao; Yonkers, Kimberly A; Ruger, Jennifer P (2014) Costs of a motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice for pregnant substance users. PLoS One 9:e95264
Davis, Katherine J; Yonkers, Kimberly A (2012) Making lemonade out of lemons: a case report and literature review of external pressure as an intervention with pregnant and parenting substance-using women. J Clin Psychiatry 73:51-6
Quesada, Odayme; Gotman, Nathan; Howell, Heather B et al. (2012) Prenatal hazardous substance use and adverse birth outcomes. J Matern Fetal Neonatal Med 25:1222-7
Yonkers, Kimberly A; Forray, Ariadna; Howell, Heather B et al. (2012) Motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice: a randomized trial for treatment of hazardous substance use in pregnancy and after delivery. Gen Hosp Psychiatry 34:439-49