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RECRUITING
NCT05128071
EARLY_PHASE1

PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)

Sponsor: University of Utah

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2022-02-04

Completion Date

2027-04

Last Updated

2024-05-21

Healthy Volunteers

No

Interventions

DRUG

Progesterone

Randomized to 400 mg (200 mg twice daily) oral micronized progesterone daily

DRUG

Placebo

Randomized to placebo twice daily

Locations (1)

University of Utah

Salt Lake City, Utah, United States