Preventing methamphetamine use in postpartum women
PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)
This study is testing if taking a hormone called progesterone can help new mothers who struggle with methamphetamine use stay off the drug.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT05128071 on ClinicalTrials.gov |
What this trial studies
The PRevention Of Methamphetamine Use among Postpartum Women Trial (PROMPT) is a randomized controlled trial aimed at postpartum individuals with methamphetamine use disorder. Participants will receive either 200 mg of oral micronized progesterone twice daily or a placebo for 12 weeks. The study seeks to evaluate the feasibility, safety, and preliminary efficacy of progesterone in preventing relapse to methamphetamine use, while also measuring salivary levels of allopregnanolone in relation to drug cravings. This research addresses a critical gap in interventions for postpartum women at risk of returning to methamphetamine use.
Who should consider this trial
Good fit: Ideal candidates for this study are postpartum women who have a history of methamphetamine use disorder but are currently abstinent.
Not a fit: Patients who are actively using methamphetamine or have not been abstinent for at least four weeks prior to enrollment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective intervention to help postpartum women avoid returning to methamphetamine use.
How similar studies have performed: While there have been successful interventions for opioid use disorder in postpartum women, this approach using progesterone for methamphetamine use is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 adjustments. * Intrauterine device or barrier method for contraception during the study period * End of pregnancy within past 12 weeks * Residing within 100 miles of study site * Stable on allowable psychiatric medications including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and mood stabilizers for four weeks prior to enrollment Exclusion Criteria: * Major medical illness in which progesterone may be contraindicated (significant liver disease, history of thrombophlebitis, stroke, heart disease, suspected or known malignancy, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders) * Any of the following laboratory abnormalities (within 2 weeks of screening and enrollment) * Active hepatic dysfunction * Anemia defined as hemoglobin less than 8 g/dL indicating anemia * Renal impairment defined as creatinine greater than 2.0 mg/dL * Hypothyroidism defined as TSH greater than 5 mIU/L * Abnormal vital signs at baseline visit * Allergy to micronized progesterone or ingredients in placebo including peanut oil, gelatin or cellulose * Self-reported progestin-containing oral or depot containing contraceptives intolerance. * Do not speak English or Spanish * Taking potent inhibitors of CY P450 3A4 including clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil and goldenseal. * Severe depressive symptoms * Active suicidality * Current or past history of psychosis, suicidal attempts or psychiatric hospitalizations * Current or pending incarceration * Active alcohol use disorder within past six months * Use of the following concomitant drugs, supplements and over-the-counter medications in the two week prior to enrollment: stimulants, barbiturates, benzodiazepines, non-benzodiazepine hypnotics, orexin antagonists, first generation anti-histamine, herbal sedatives, methaqualone and analogues, skeletal muscle relaxants, opioids (other than methadone or buprenorphine), anti-psychotic medications, certain anti-depressants or other medication with significant sedative properties as evaluated by the PI and/or study clinician. * Progestin containing medications including oral hormonal contraceptive methods
Where this trial is running
Salt Lake City, Utah
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Marcela Smid, MD — University of Utha
- Study coordinator: Kristi Carlston
- Email: Kristi.carlston@hsc.utah.edu
- Phone: 801-213-0799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.