PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Feb 2022
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedStudy Start
First participant enrolled
February 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedMay 21, 2024
May 1, 2024
4.2 years
September 9, 2021
May 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful recruitment and randomization of 40 postpartum women into the PROMPT study
Recruit and enroll 40 eligible women in a 15 month period from time of study initiation.
15 months after study initiation
Secondary Outcomes (5)
Assess medication side effects through review of the GASE in enrolled participants
12 weeks
Assess depression and suicidality status in enrolled participants
12 weeks
Assess anxiety status in enrolled participants
12 weeks
Assess breastfeeding difficulty in enrolled participants
12 weeks
Assess return to methamphetamine use (MU) in enrolled participants
12 weeks
Study Arms (2)
Progesterone Arm
ACTIVE COMPARATORRandomized to receive progesterone
Placebo Arm
PLACEBO COMPARATORRandomized to receive placebo
Interventions
Randomized to 400 mg (200 mg twice daily) oral micronized progesterone daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84132, United States
Related Publications (10)
Forray A, Merry B, Lin H, Ruger JP, Yonkers KA. Perinatal substance use: a prospective evaluation of abstinence and relapse. Drug Alcohol Depend. 2015 May 1;150:147-55. doi: 10.1016/j.drugalcdep.2015.02.027. Epub 2015 Mar 3.
PMID: 25772437BACKGROUNDSmid MC, Stone NM, Baksh L, Debbink MP, Einerson BD, Varner MW, Gordon AJ, Clark EAS. Pregnancy-Associated Death in Utah: Contribution of Drug-Induced Deaths. Obstet Gynecol. 2019 Jun;133(6):1131-1140. doi: 10.1097/AOG.0000000000003279.
PMID: 31135726BACKGROUNDJones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.
PMID: 21142534BACKGROUNDWiegand SL, Stringer EM, Stuebe AM, Jones H, Seashore C, Thorp J. Buprenorphine and naloxone compared with methadone treatment in pregnancy. Obstet Gynecol. 2015 Feb;125(2):363-368. doi: 10.1097/AOG.0000000000000640.
PMID: 25569005BACKGROUNDYonkers KA, Forray A, Nich C, Carroll KM, Hine C, Merry BC, Shaw H, Shaw J, Sofuoglu M. Progesterone Reduces Cocaine Use in Postpartum Women with a Cocaine Use Disorder: A Randomized,Double-Blind Study. Lancet Psychiatry. 2014 Oct 1;1(5):360-367. doi: 10.1016/S2215-0366(14)70333-5.
PMID: 25328863BACKGROUNDBattle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
PMID: 24413388BACKGROUNDEllis MS, Kasper ZA, Cicero TJ. Twin epidemics: The surging rise of methamphetamine use in chronic opioid users. Drug Alcohol Depend. 2018 Dec 1;193:14-20. doi: 10.1016/j.drugalcdep.2018.08.029. Epub 2018 Oct 10.
PMID: 30326396BACKGROUNDKuo CJ, Liao YT, Chen WJ, Tsai SY, Lin SK, Chen CC. Causes of death of patients with methamphetamine dependence: a record-linkage study. Drug Alcohol Rev. 2011 Nov;30(6):621-8. doi: 10.1111/j.1465-3362.2010.00255.x. Epub 2010 Oct 18.
PMID: 21355920BACKGROUNDChen LH, Hedegaard H, Warner M. Drug-poisoning Deaths Involving Opioid Analgesics: United States, 1999-2011. NCHS Data Brief. 2014 Sep;(166):1-8.
PMID: 25228059BACKGROUNDHedegaard H, Minino AM, Warner M. Drug Overdose Deaths in the United States, 1999-2018. NCHS Data Brief. 2020 Jan;(356):1-8.
PMID: 32487285BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcela Smid, MD
University of Utha
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double blind, placebo controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, MD
Study Record Dates
First Submitted
September 9, 2021
First Posted
November 19, 2021
Study Start
February 4, 2022
Primary Completion
April 30, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
May 21, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share