Actively Recruiting
PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)
Led by University of Utah · Updated on 2024-05-21
40
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 diagnosed with active opioid use disorder, no use at enrollment or within past 4 weeks and stable on medication for opioid use disorder for two weeks prior to enrollment
- Using intrauterine device or barrier contraception during study period
- Delivered baby within past 12 weeks
- Living within 100 miles of study site
- Stable on allowable psychiatric medications for four weeks prior to enrollment
You will not qualify if you...
- Major medical illness contraindicating progesterone (e.g., significant liver disease, history of thrombophlebitis, stroke, heart disease, malignancy, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders)
- Laboratory abnormalities within 2 weeks of screening including active hepatic dysfunction, anemia (hemoglobin < 8 g/dL), renal impairment (creatinine > 2.0 mg/dL), hypothyroidism (TSH > 5 mIU/L)
- Abnormal vital signs at baseline visit
- Allergy to micronized progesterone or placebo ingredients including peanut oil, gelatin, or cellulose
- Intolerance to progestin-containing oral or depot contraceptives
- Do not speak English or Spanish
- Taking potent CYP450 3A4 inhibitors (e.g., clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal)
- Severe depressive symptoms or active suicidality
- Current or past psychosis, suicide attempts, or psychiatric hospitalizations
- Current or pending incarceration
- Active alcohol use disorder within past six months
- Use of stimulants, barbiturates, benzodiazepines, non-benzodiazepine hypnotics, orexin antagonists, first generation antihistamines, herbal sedatives, methaqualone, skeletal muscle relaxants, opioids (except methadone or buprenorphine), antipsychotics, certain antidepressants, or other sedative medications in two weeks prior to enrollment
- Use of progestin-containing medications including oral hormonal contraceptives
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
K
Kristi Carlston
CONTACT
G
Grace Humiston
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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