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PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)

NCT05128071 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-21

No results posted yet for this study

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.

Conditions

  • Methamphetamine-dependence
  • Postpartum Abstinence

Interventions

DRUG

Progesterone

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

DRUG

Placebo

Randomized to placebo twice daily

Sponsors & Collaborators

Principal Investigators

  • Marcela Smid, MD · University of Utha

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-04
Primary Completion
2026-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128071 on ClinicalTrials.gov