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Progesterone for Methamphetamine Addiction in Postpartum Women

Phase < 1
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No active methamphetamine use at time of enrollment or within past 4 weeks prior to enrollment by self-report or urine toxicology
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months after study initiation
Awards & highlights

Study Summary

This trial is testing whether a hormone called progesterone can help prevent postpartum women with methamphetamine use disorder from returning to methamphetamine use. A secondary aim is to assess whether the hormone allopregnanolone, which is increased by progesterone, is associated with reduced methamphetamine cravings.

Who is the study for?
The PROMPT trial is for postpartum individuals who have struggled with methamphetamine use but haven't used it in the last 4 weeks. They should be within 12 weeks after giving birth, living close to the study site, and using certain contraception methods. People with major illnesses or on medications that could interact badly with progesterone aren't eligible.Check my eligibility
What is being tested?
This study tests if taking oral micronized progesterone twice daily can help prevent returning to methamphetamine use in postpartum women compared to a placebo. It also looks at how this hormone affects cravings by measuring salivary levels of allopregnanolone.See study design
What are the potential side effects?
Progesterone may cause mood swings, headaches, bloating, breast tenderness, changes in menstrual flow or sleep patterns. The side effects vary from person to person and some might not experience any noticeable issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not used methamphetamine in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months after study initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months after study initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful recruitment and randomization of 40 postpartum women into the PROMPT study
Secondary outcome measures
Assess anxiety status in enrolled participants
Assess breastfeeding difficulty in enrolled participants
Assess depression and suicidality status in enrolled participants
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Progesterone ArmActive Control1 Intervention
Randomized to receive progesterone
Group II: Placebo ArmPlacebo Group1 Intervention
Randomized to receive placebo

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,092 Previous Clinical Trials
1,732,952 Total Patients Enrolled
Marcela Smid, MDStudy DirectorUniversity of Utha

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05128071 — Phase < 1
Methamphetamine Addiction Research Study Groups: Progesterone Arm, Placebo Arm
Methamphetamine Addiction Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05128071 — Phase < 1
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128071 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are involved in the current clinical trial?

"Affirmative, according to the information hosted on clinicaltrials.gov this medical trial is actively seeking participants. This research was first posted February 4th 2022 and has been revised as recently as April 15th 2022 with a need for 40 individuals at one site."

Answered by AI

Are any of the participating facilities still enrolling individuals in this research study?

"Affirmative. Per the information listed on clinicaltrials.gov, this medical trial is actively seeking volunteers with its posting date of February 4th 2022 and most recent update occurring April 15th 2022. 40 participants are needed from a single location."

Answered by AI

What pathologies does Progesterone Arm typically aid in remedying?

"Progesterone Arm has been used to treat various ailments, such as uterine hemorrhage, hormonal imbalance and endometrial hyperplasia caused by conjugated estrogen. Additionally, it can be administered as a preventative measure against recurrent spontaneous preterm birth."

Answered by AI

What former experiments have focused on the Progesterone Arm?

"Currently, the landscape of clinical trials for Progesterone Arm is comprised of 42 distinct studies; 8 are in their terminal phase. Of these experiments, 268 different sites across the world offer participation - many being located in Barcelona, Catalunya."

Answered by AI

Who else is applying?

What site did they apply to?
University of Utah
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~2 spots leftby Apr 2024