CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 34 enrolled / 34 target
Drug / intervention
Progesterone +1 moredrug
Likely dose
Progesterone 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05128071
NCT05128071Early Ph 1CompletedOn Track (0.6/mo)Completion was 25mo ago
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PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)

University of Utah·interventional·Posted Nov 19, 2021·Updated Jun 3, 2026

In Brief

A Early Phase 1 clinical trial evaluating Progesterone and Placebo for Methamphetamine-dependence and Postpartum Abstinence. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMethamphetamine-dependence, Postpartum Abstinence
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20222023202420252026
First PostedNov 19, 2021
Enrollment StartFeb 4, 2022
Primary CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.6 years ago

Arms & Interventions

Progesterone Armactive_comparator

Randomized to receive progesterone

Drug: Progesterone
Placebo Armplacebo_comparator

Randomized to receive placebo

Drug: Placebo

Interventions

Progesteronedrug

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

Placebodrug

Randomized to placebo twice daily