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 range

18 Years

Sex

FEMALE

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

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

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