{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T17:32:16Z","timestamp":1787851936079,"version":"build-2784847793"},"reference-count":45,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2024,8,28]],"date-time":"2024-08-28T00:00:00Z","timestamp":1724803200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["3R21DA053463-02S1"],"award-info":[{"award-number":["3R21DA053463-02S1"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","award":["UL1TR002538"],"award-info":[{"award-number":["UL1TR002538"]}],"id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Contemporary Clinical Trials Communications"],"published-print":{"date-parts":[[2024,10]]},"DOI":"10.1016\/j.conctc.2024.101359","type":"journal-article","created":{"date-parts":[[2024,8,30]],"date-time":"2024-08-30T01:20:50Z","timestamp":1724980850000},"page":"101359","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":2,"special_numbering":"C","title":["Prevention of postpartum methamphetamine use with micronized progesterone trial (PROMPT): A pilot randomized controlled trial protocol"],"prefix":"10.1016","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3010-0662","authenticated-orcid":false,"given":"Marcela C.","family":"Smid","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9375-1767","authenticated-orcid":false,"given":"Natasha","family":"Seliski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmin E.","family":"Charles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-3171-9782","authenticated-orcid":false,"given":"Stephanie","family":"Castro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-9870-520X","authenticated-orcid":false,"given":"Grace E.","family":"Humiston","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6444-233X","authenticated-orcid":false,"given":"Elysha","family":"Cash","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0109-7193","authenticated-orcid":false,"given":"Amanda","family":"Allshouse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Turner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristi","family":"Carlston","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Gibson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam J.","family":"Gordon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerald T.","family":"Cochran","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"12","key":"10.1016\/j.conctc.2024.101359_bib1","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2022.48055","article-title":"Trends in self-reported and biochemically verified cocaine and methamphetamine use among pregnant individuals in northern California, 2011-2019","volume":"5","author":"Young-Wolff","year":"2022","journal-title":"JAMA Netw. Open"},{"issue":"1","key":"10.1016\/j.conctc.2024.101359_bib2","doi-asserted-by":"crossref","first-page":"148","DOI":"10.2105\/AJPH.2018.304771","article-title":"Amphetamine- and opioid-affected births: incidence, outcomes, and costs, United States, 2004-2015","volume":"109","author":"Admon","year":"2019","journal-title":"Am J Public Health"},{"issue":"2","key":"10.1016\/j.conctc.2024.101359_bib3","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1097\/AOG.0000000000004868","article-title":"Umbilical cord collection and drug testing to estimate prenatal substance exposure in Utah","volume":"140","author":"Smid","year":"2022","journal-title":"Obstet. Gynecol."},{"issue":"1","key":"10.1016\/j.conctc.2024.101359_bib4","doi-asserted-by":"crossref","DOI":"10.1016\/j.ajogmf.2023.101221","article-title":"Co-occurring opioid and methamphetamine use disorder and severe maternal morbidity and mortality in Utah","volume":"6","author":"Smid","year":"2024","journal-title":"American journal of obstetrics & gynecology MFM"},{"issue":"21","key":"10.1016\/j.conctc.2024.101359_bib5","doi-asserted-by":"crossref","first-page":"2159","DOI":"10.1001\/jama.2022.17045","article-title":"US trends in drug overdose mortality among pregnant and postpartum persons, 2017-2020","volume":"328","author":"Bruzelius","year":"2022","journal-title":"JAMA"},{"key":"10.1016\/j.conctc.2024.101359_bib6","doi-asserted-by":"crossref","first-page":"147","DOI":"10.1016\/j.drugalcdep.2015.02.027","article-title":"Perinatal substance use: a prospective evaluation of abstinence and relapse","volume":"150","author":"Forray","year":"2015","journal-title":"Drug Alcohol Depend."},{"issue":"6","key":"10.1016\/j.conctc.2024.101359_bib7","doi-asserted-by":"crossref","first-page":"1233","DOI":"10.1097\/AOG.0000000000001695","article-title":"Maternal deaths from suicide and overdose in Colorado, 2004-2012","volume":"128","author":"Metz","year":"2016","journal-title":"Obstet. Gynecol."},{"issue":"4","key":"10.1016\/j.conctc.2024.101359_bib8","doi-asserted-by":"crossref","first-page":"645","DOI":"10.1097\/AOG.0000000000003988","article-title":"Standardized criteria for review of perinatal suicides and accidental drug-related deaths","volume":"136","author":"Smid","year":"2020","journal-title":"Obstet. Gynecol."},{"issue":"5","key":"10.1016\/j.conctc.2024.101359_bib9","doi-asserted-by":"crossref","first-page":"479","DOI":"10.1080\/03630242.2013.804025","article-title":"Postpartum substance use and depressive symptoms: a review","volume":"53","author":"Chapman","year":"2013","journal-title":"Women Health"},{"issue":"2","key":"10.1016\/j.conctc.2024.101359_bib10","doi-asserted-by":"crossref","first-page":"466","DOI":"10.1097\/AOG.0000000000002734","article-title":"Fatal and nonfatal overdose among pregnant and postpartum women in Massachusetts","volume":"132","author":"Schiff","year":"2018","journal-title":"Obstet. Gynecol."},{"key":"10.1016\/j.conctc.2024.101359_bib11","doi-asserted-by":"crossref","DOI":"10.1016\/j.drugalcdep.2023.110944","article-title":"Outcomes and experiences after child custody loss among mothers who use drugs: a mixed studies systematic review","volume":"251","author":"Darlington","year":"2023","journal-title":"Drug Alcohol Depend."},{"issue":"11","key":"10.1016\/j.conctc.2024.101359_bib12","doi-asserted-by":"crossref","first-page":"91","DOI":"10.1007\/s11920-015-0626-5","article-title":"Substance use in the perinatal period","volume":"17","author":"Forray","year":"2015","journal-title":"Curr Psychiatry Rep"},{"issue":"5","key":"10.1016\/j.conctc.2024.101359_bib13","doi-asserted-by":"crossref","first-page":"461","DOI":"10.1037\/1064-1297.15.5.461","article-title":"Effects of estrogen and progesterone on the escalation of cocaine self-administration in female rats during extended access","volume":"15","author":"Larson","year":"2007","journal-title":"Exp. Clin. Psychopharmacol"},{"issue":"3","key":"10.1016\/j.conctc.2024.101359_bib14","doi-asserted-by":"crossref","first-page":"343","DOI":"10.1016\/j.psyneuen.2008.09.014","article-title":"Attenuation of cocaine-seeking by progesterone treatment in female rats","volume":"34","author":"Feltenstein","year":"2009","journal-title":"Psychoneuroendocrinology"},{"issue":"5","key":"10.1016\/j.conctc.2024.101359_bib15","doi-asserted-by":"crossref","first-page":"445","DOI":"10.1037\/1064-1297.15.5.445","article-title":"Sex steroid hormones, stress response, and drug craving in cocaine-dependent women: implications for relapse susceptibility","volume":"15","author":"Sinha","year":"2007","journal-title":"Exp. Clin. Psychopharmacol"},{"issue":"3","key":"10.1016\/j.conctc.2024.101359_bib16","doi-asserted-by":"crossref","first-page":"659","DOI":"10.1038\/sj.npp.1300887","article-title":"Exogenous progesterone attenuates the subjective effects of smoked cocaine in women, but not in men","volume":"31","author":"Evans","year":"2006","journal-title":"Neuropsychopharmacology"},{"key":"10.1016\/j.conctc.2024.101359_bib17","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1016\/j.psyneuen.2017.09.012","article-title":"Progesterone for smoking relapse prevention following delivery: a pilot, randomized, double-blind study","volume":"86","author":"Forray","year":"2017","journal-title":"Psychoneuroendocrinology"},{"issue":"11","key":"10.1016\/j.conctc.2024.101359_bib18","doi-asserted-by":"crossref","first-page":"2145","DOI":"10.1093\/ntr\/ntw156","article-title":"Progesterone and postpartum smoking relapse: a pilot double-blind placebo-controlled randomized trial","volume":"18","author":"Allen","year":"2016","journal-title":"Nicotine Tob. Res."},{"issue":"5","key":"10.1016\/j.conctc.2024.101359_bib19","doi-asserted-by":"crossref","first-page":"360","DOI":"10.1016\/S2215-0366(14)70333-5","article-title":"Progesterone reduces cocaine use in postpartum women with a cocaine use disorder: a Randomized,Double-blind study","volume":"1","author":"Yonkers","year":"2014","journal-title":"Lancet Psychiatr."},{"issue":"1","key":"10.1016\/j.conctc.2024.101359_bib20","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1111\/gbb.12321","article-title":"GABA(A) receptor subtype involvement in addictive behaviour","volume":"16","author":"Stephens","year":"2017","journal-title":"Genes Brain Behav"},{"issue":"5","key":"10.1016\/j.conctc.2024.101359_bib21","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1007\/s40263-018-0525-5","article-title":"Role of exogenous progesterone in the treatment of men and women with substance use disorders: a narrative review","volume":"32","author":"Peltier","year":"2018","journal-title":"CNS Drugs"},{"key":"10.1016\/j.conctc.2024.101359_bib22","series-title":"Diagnostic and Statistical Manual of Mental Disorders","year":"2022"},{"key":"10.1016\/j.conctc.2024.101359_bib23","article-title":"Allopregnanolone in postpartum depression: role in pathophysiology and treatment","volume":"12","author":"Meltzer-Brody","year":"2020","journal-title":"Neurobiol Stress"},{"issue":"474","key":"10.1016\/j.conctc.2024.101359_bib24","first-page":"1","article-title":"Co-Involvement of opioids in drug overdose deaths involving cocaine and psychostimulants, 2011-2021","author":"Spencer","year":"2023","journal-title":"NCHS Data Brief"},{"issue":"3","key":"10.1016\/j.conctc.2024.101359_bib25","doi-asserted-by":"crossref","first-page":"556","DOI":"10.1097\/AOG.0000000000003907","article-title":"Polysubstance use among pregnant women with opioid use disorder in the United States, 2007-2016","volume":"136","author":"Jarlenski","year":"2020","journal-title":"Obstet. Gynecol."},{"issue":"9","key":"10.1016\/j.conctc.2024.101359_bib26","doi-asserted-by":"crossref","first-page":"1624","DOI":"10.1111\/add.16200","article-title":"Agreement between self-reported illicit drug use and biological samples: a systematic review and meta-analysis","volume":"118","author":"Bharat","year":"2023","journal-title":"Addiction"},{"issue":"5","key":"10.1016\/j.conctc.2024.101359_bib27","doi-asserted-by":"crossref","first-page":"618","DOI":"10.1097\/ADM.0000000000001173","article-title":"Secondary analysis of agreement between negative timeline follow back report and negative urine toxicology in a large trial of individuals with opioid use disorder","volume":"17","author":"Shulman","year":"2023","journal-title":"J Addict Med"},{"key":"10.1016\/j.conctc.2024.101359_bib28","doi-asserted-by":"crossref","DOI":"10.1016\/j.jsat.2021.108555","article-title":"Comparison of self-reported substance use with biological testing among treatment-seeking patients with opioid use disorder","volume":"134","author":"Shadloo","year":"2022","journal-title":"J. Subst. Abuse Treat."},{"key":"10.1016\/j.conctc.2024.101359_bib29","unstructured":"Solvay Pharmaceuticals inc. Prometrium (progesterone) [package insert]. U.S. Food and Drug Administration website. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2009\/019781s013lbl.pdf. Revised June 2009. Accessed October 15, 2023."},{"key":"10.1016\/j.conctc.2024.101359_bib30","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1016\/j.bpobgyn.2020.06.001","article-title":"Progesterone, reproduction, and psychiatric illness","volume":"69","author":"Standeven","year":"2020","journal-title":"Best Pract. Res. Clin. Obstet. Gynaecol."},{"key":"10.1016\/j.conctc.2024.101359_bib31","doi-asserted-by":"crossref","first-page":"782","DOI":"10.1192\/bjp.150.6.782","article-title":"Detection of postnatal depression. Development of the 10-item Edinburgh postnatal depression scale","volume":"150","author":"Cox","year":"1987","journal-title":"The British journal of psychiatry : J. Ment. Sci."},{"issue":"10","key":"10.1016\/j.conctc.2024.101359_bib32","doi-asserted-by":"crossref","first-page":"1092","DOI":"10.1001\/archinte.166.10.1092","article-title":"A brief measure for assessing generalized anxiety disorder: the GAD-7","volume":"166","author":"Spitzer","year":"2006","journal-title":"Arch. Intern. Med."},{"issue":"12","key":"10.1016\/j.conctc.2024.101359_bib33","doi-asserted-by":"crossref","first-page":"1266","DOI":"10.1176\/appi.ajp.2011.10111704","article-title":"The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults","volume":"168","author":"Posner","year":"2011","journal-title":"Am J Psychiatry"},{"issue":"1","key":"10.1016\/j.conctc.2024.101359_bib34","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1016\/0303-7207(93)90138-A","article-title":"Progesterone inhibits the estrogen-induced prolactin gene expression in the rat pituitary","volume":"93","author":"Cho","year":"1993","journal-title":"Mol. Cell. Endocrinol."},{"issue":"5","key":"10.1016\/j.conctc.2024.101359_bib35","doi-asserted-by":"crossref","first-page":"332","DOI":"10.1111\/j.1752-8062.2011.00347.x","article-title":"Recommendations for planning pilot studies in clinical and translational research","volume":"4","author":"Moore","year":"2011","journal-title":"Clin Transl Sci"},{"issue":"5","key":"10.1016\/j.conctc.2024.101359_bib36","doi-asserted-by":"crossref","first-page":"626","DOI":"10.1016\/j.jpsychires.2010.10.008","article-title":"The role and interpretation of pilot studies in clinical research","volume":"45","author":"Leon","year":"2011","journal-title":"J. Psychiatr. Res."},{"issue":"4","key":"10.1016\/j.conctc.2024.101359_bib37","doi-asserted-by":"crossref","first-page":"405","DOI":"10.1002\/pds.2067","article-title":"Assessing general side effects in clinical trials: reference data from the general population","volume":"20","author":"Rief","year":"2011","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"10.1016\/j.conctc.2024.101359_bib38","doi-asserted-by":"crossref","DOI":"10.1016\/j.cct.2020.106014","article-title":"Medication treatment for opioid use disorder in expectant mothers (MOMs): design considerations for a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations","volume":"93","author":"Winhusen","year":"2020","journal-title":"Contemp. Clin. Trials"},{"issue":"1","key":"10.1016\/j.conctc.2024.101359_bib39","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1016\/j.midw.2014.07.001","article-title":"The development of a new breast feeding assessment tool and the relationship with breast feeding self-efficacy","volume":"31","author":"Ingram","year":"2015","journal-title":"Midwifery"},{"key":"10.1016\/j.conctc.2024.101359_bib40","series-title":"Measuring Alcohol Consumption","first-page":"41","article-title":"Timeline follow-back","author":"Sobell","year":"1992"},{"issue":"16","key":"10.1016\/j.conctc.2024.101359_bib41","doi-asserted-by":"crossref","first-page":"1344","DOI":"10.2146\/ajhp090477","article-title":"Commonly prescribed medications and potential false-positive urine drug screens","volume":"67","author":"Brahm","year":"2010","journal-title":"Am. J. Health Syst. Pharm."},{"issue":"3","key":"10.1016\/j.conctc.2024.101359_bib42","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1016\/j.drugalcdep.2005.11.022","article-title":"The validity and reliability of a brief measure of cocaine craving","volume":"83","author":"Sussner","year":"2006","journal-title":"Drug Alcohol Depend."},{"issue":"5","key":"10.1016\/j.conctc.2024.101359_bib44","doi-asserted-by":"crossref","first-page":"1077","DOI":"10.1097\/AOG.0b013e3182a9ca67","article-title":"Exclusion of pregnant women from industry-sponsored clinical trials","volume":"122","author":"Shields","year":"2013","journal-title":"Obstet. Gynecol."},{"issue":"4","key":"10.1016\/j.conctc.2024.101359_bib45","doi-asserted-by":"crossref","first-page":"189","DOI":"10.3928\/00485713-20210303-01","article-title":"Perinatal methamphetamine use: a review of the literature","volume":"51","author":"Hickert","year":"2021","journal-title":"Psychiatr. Ann."},{"key":"10.1016\/j.conctc.2024.101359_bib46","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1016\/j.ntt.2015.07.006","article-title":"Developmental and behavioral consequences of prenatal methamphetamine exposure: a review of the Infant Development, Environment, and Lifestyle (IDEAL) study","volume":"51","author":"Smith","year":"2015","journal-title":"Neurotoxicol. Teratol."}],"container-title":["Contemporary Clinical Trials Communications"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2451865424001066?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2451865424001066?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T23:31:36Z","timestamp":1778887896000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2451865424001066"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10]]},"references-count":45,"alternative-id":["S2451865424001066"],"URL":"https:\/\/doi.org\/10.1016\/j.conctc.2024.101359","relation":{},"ISSN":["2451-8654"],"issn-type":[{"value":"2451-8654","type":"print"}],"subject":[],"published":{"date-parts":[[2024,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Prevention of postpartum methamphetamine use with micronized progesterone trial (PROMPT): A pilot randomized controlled trial protocol","name":"articletitle","label":"Article Title"},{"value":"Contemporary Clinical Trials Communications","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.conctc.2024.101359","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 The Authors. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}],"article-number":"101359"}}