WithdrawnPhase 4

Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

Stopped: No enrollment

0Started 2018-11-30

Plain-language summary

This study will assesses the efficacy of buprenorphine/naloxone vs buprenorphine on maternal withdrawal symptoms and drug cravings. 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

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age and older * 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: * Known or suspected allergy to buprenorphine or buprenorphine/naloxone * Carrying a fetus with known aneuploidy or anomaly

What they're measuring

Compliance antepartum

Timeframe: From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)

Compliance postpartum

Timeframe: 2 month period postpartum

Dosing antepartum

Timeframe: From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)

Dosing postpartum

Timeframe: 2 month period postpartum

Trial details

NCT IDNCT03740243

SponsorStony Brook University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-22

View on ClinicalTrials.gov More Opioid-use Disorder trials