Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology
NCT ID: NCT03740243
Last Updated: 2020-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2018-11-30
2020-03-22
Brief Summary
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This is a randomized controlled trial to a cohort of pregnant women seeking medication-assisted treatment for opioid use disorders. Half of participants will receive buprenorphine, while the other half of participants receive a combination of buprenorphine/naloxone
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Detailed Description
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Buprenorphine has many preferential characteristics over methadone including decreased risk of maternal overdose, lower incidence of preterm labor, less frequent clinical visits, shorter duration of neonatal hospital stay and treatment for neonatal abstinence syndrome. Recent studies have found that increasing the dosing frequencies of buprenorphine is more efficacious to prevent maternal withdrawal symptoms, improve compliance, and theoretically produce better pregnancy outcomes.
Buprenorphine/naloxone, a combination opioid of buprenorphine and naloxone, has also been investigated as an alternative to treatment and maintenance for opioid use disorder. The advantage of the combination of buprenorphine with naloxone is that it reduces the potential for abuse. As a partial mu opioid agonist, buprenorphine alone has the capacity to induce typical opioid effects such as euphoria, which are enhanced when the drug is taken intravenously. By combining buprenorphine with naloxone, an opioid antagonist, the capacity for buprenorphine to be abused is reduced.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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buprenorphine
Buprenorphine 2 mg to 8 mg daily: Light to moderate history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 5-24
Buprenorphine 8 mg to 16 mg daily: Heavy history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 25-36+
Buprenorphine
Buprenorphine tablet
buprenorphine/naloxone
Buprenorphine/naloxone 4 mg/1 mg daily once daily or twice daily (BID): Light to moderate history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 5-24
Buprenorphine/naloxone 8 mg/2 mg daily once daily or twice daily (BID): Heavy history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 25-36+
Buprenorphine/naloxone
Buprenorphine/naloxone tablet or film
Interventions
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Buprenorphine/naloxone
Buprenorphine/naloxone tablet or film
Buprenorphine
Buprenorphine tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With a confirmed viable intrauterine pregnancy
* Opioid Use Disorder
* Care in a Stony Brook Medicine OBGYN clinical office sites
* Medication-assisted treatment through Stony Brook Medicine OBGYN office sites
Exclusion Criteria
* Carrying a fetus with known aneuploidy or anomaly
18 Years
FEMALE
Yes
Sponsors
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Stony Brook University
OTHER
Responsible Party
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David Garry DO
Director, Maternal Fetal Medicine
Principal Investigators
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David J Garry, DO
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University
References
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Committee Opinion No. 711: Opioid Use and Opioid Use Disorder in Pregnancy. Obstet Gynecol. 2017 Aug;130(2):e81-e94. doi: 10.1097/AOG.0000000000002235.
Bastian JR, Chen H, Zhang H, Rothenberger S, Tarter R, English D, Venkataramanan R, Caritis SN. Dose-adjusted plasma concentrations of sublingual buprenorphine are lower during than after pregnancy. Am J Obstet Gynecol. 2017 Jan;216(1):64.e1-64.e7. doi: 10.1016/j.ajog.2016.09.095. Epub 2016 Sep 26.
Caritis SN, Bastian JR, Zhang H, Kalluri H, English D, England M, Bobby S, Venkataramanan R. An evidence-based recommendation to increase the dosing frequency of buprenorphine during pregnancy. Am J Obstet Gynecol. 2017 Oct;217(4):459.e1-459.e6. doi: 10.1016/j.ajog.2017.06.029. Epub 2017 Jun 29.
Chavan NR, Ashford KB, Wiggins AT, Lofwall MR, Critchfield AS. Buprenorphine for Medication-Assisted Treatment of Opioid Use Disorder in Pregnancy: Relationship to Neonatal Opioid Withdrawal Syndrome. AJP Rep. 2017 Oct;7(4):e215-e222. doi: 10.1055/s-0037-1608783. Epub 2017 Dec 7.
Debelak K, Morrone WR, O'Grady KE, Jones HE. Buprenorphine + naloxone in the treatment of opioid dependence during pregnancy-initial patient care and outcome data. Am J Addict. 2013 May-Jun;22(3):252-4. doi: 10.1111/j.1521-0391.2012.12005.x.
Geber WF, Schramm LC. Congenital malformations of the central nervous system produced by narcotic analgesics in the hamster. Am J Obstet Gynecol. 1975 Dec 1;123(7):705-13. doi: 10.1016/0002-9378(75)90492-5.
Fudala PJ, Bridge TP, Herbert S, Williford WO, Chiang CN, Jones K, Collins J, Raisch D, Casadonte P, Goldsmith RJ, Ling W, Malkerneker U, McNicholas L, Renner J, Stine S, Tusel D; Buprenorphine/Naloxone Collaborative Study Group. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med. 2003 Sep 4;349(10):949-58. doi: 10.1056/NEJMoa022164.
Jumah NA, Edwards C, Balfour-Boehm J, Loewen K, Dooley J, Gerber Finn L, Kelly L. Observational study of the safety of buprenorphine+naloxone in pregnancy in a rural and remote population. BMJ Open. 2016 Oct 31;6(10):e011774. doi: 10.1136/bmjopen-2016-011774.
Lund IO, Fischer G, Welle-Strand GK, O'Grady KE, Debelak K, Morrone WR, Jones HE. A Comparison of Buprenorphine + Naloxone to Buprenorphine and Methadone in the Treatment of Opioid Dependence during Pregnancy: Maternal and Neonatal Outcomes. Subst Abuse. 2013;7:61-74. doi: 10.4137/SART.S10955. Epub 2013 Mar 14.
Mendelson J, Jones RT. Clinical and pharmacological evaluation of buprenorphine and naloxone combinations: why the 4:1 ratio for treatment? Drug Alcohol Depend. 2003 May 21;70(2 Suppl):S29-37. doi: 10.1016/s0376-8716(03)00057-7.
Nguyen L, Lander LR, O'Grady KE, Marshalek PJ, Schmidt A, Kelly AK, Jones HE. Treating women with opioid use disorder during pregnancy in Appalachia: Initial neonatal outcomes following buprenorphine + naloxone exposure. Am J Addict. 2018 Mar;27(2):92-96. doi: 10.1111/ajad.12687. Epub 2018 Feb 23.
Poon S, Pupco A, Koren G, Bozzo P. Safety of the newer class of opioid antagonists in pregnancy. Can Fam Physician. 2014 Jul;60(7):631-2, e348-9.
Simojoki K, Vorma H, Alho H. A retrospective evaluation of patients switched from buprenorphine (Subutex) to the buprenorphine/naloxone combination (Suboxone). Subst Abuse Treat Prev Policy. 2008 Jun 17;3:16. doi: 10.1186/1747-597X-3-16.
Strain EC, Harrison JA, Bigelow GE. Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/naloxone soluble-films. Clin Pharmacol Ther. 2011 Mar;89(3):443-9. doi: 10.1038/clpt.2010.352. Epub 2011 Jan 26.
Wiegand 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Protocol and SAP
Document Type: Informed Consent Form
Document Type: Study Protocol: COWS questionnaire and Brief Substance Cravings scale
Other Identifiers
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1175806
Identifier Type: -
Identifier Source: org_study_id
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