PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)
University of Utah
Summary
The PRevention Of Methamphetamine Use among Postpartum Women Trial (PROMPT) is randomized controlled trial of postpartum individuals with methamphetamine use disorder to 12 weeks of 200 mg oral micronized progesterone twice daily or placebo. The aims of this study are to assess the feasibility, safety and preliminary efficacy of micronized progesterone for the prevention of return to methamphetamine use. A secondary aim is to assess participant's salivary levels of allopregnanolone with methamphetamine cravings. This study has the potential to provide effective interventions to prevent methamphetamine use among postpartum women.
Description
While substantial attention and resources have been directed at the opioid epidemic in the US, another deadly drug epidemic - methamphetamine use (MU) - has been evolving. While most pregnant women achieve abstinence by late pregnancy, the postpartum period is a particularly vulnerable time. Postpartum return to use is high and potentially deadly. Data from the Utah Maternal Mortality Review Committee indicate that from 2005-2016 (n=176), MU contributed to one out of every five deaths of pregnant and postpartum women; 85% of these deaths occurred in the postpartum period and, 70% of methamphet…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Meeting criteria for substance use disorder of methamphetamine in the six months prior to conception or during pregnancy * No active methamphetamine use at time of enrollment or within past 4 weeks prior to enrollment by self-report or urine toxicology. * If diagnosis of active opioid use disorder (OUD) and no use at time of enrollment or within past 4 weeks prior to enrollment by self-report or urine toxicology and on stable dose of medication for OUD (methadone, buprenorphine, naltrexone) for two weeks prior to enrollment in order to allow for postpartum dose adjustmen…
Interventions
- DrugProgesterone
Randomized to 400 mg (200 mg twice daily) oral micronized progesterone daily
- DrugPlacebo
Randomized to placebo twice daily
Location
- University of UtahSalt Lake City, Utah