RECRUITING

PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)

Conditions

Methamphetamine-dependence Postpartum Abstinence Pregnancy Postpartum

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)

Quick Facts

Study Start:2022-02-04

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05128071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Kristi Carlston

CONTACT

801-213-0799

Kristi.carlston@hsc.utah.edu

Grace Humiston

CONTACT

385-831-3786

Grace.humiston@hsc.utah.edu

Principal Investigator

Marcela Smid, MD

PRINCIPAL_INVESTIGATOR

University of Utha

Study Locations (Sites)

University of Utah

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: University of Utah

Marcela Smid, MD, PRINCIPAL_INVESTIGATOR, University of Utha

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-04

Study Completion Date2027-04

Study Record Updates

Study Start Date2022-02-04

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

Pregnancy
Postpartum

Additional Relevant MeSH Terms

Methamphetamine-dependence
Postpartum Abstinence