Clinical trial NCT03740243: Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology
Official title: Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Opioid-use Disorder
Keywords: opioid use disorder
Buprenorphine/naloxone
Buprenorphine
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: Buprenorphine and Buprenorphine/naloxone each are used to treat opioid use disorders in pregnancy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance antepartum
timeFrame: From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)
measure: Compliance postpartum
timeFrame: 2 month period postpartum
measure: Dosing antepartum
timeFrame: From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)
measure: Dosing postpartum
timeFrame: 2 month period postpartum
Secondary outcomes:
measure: Maternal Outcomes Withdraw Scoring
timeFrame: Duration of pregnancy and 2 months of postpartum period
measure: Maternal Outcome Metabolites
timeFrame: At delivery of newborn
measure: Placental dysmaturity
timeFrame: At delivery of newborn
measure: Neonatal Outcomes
timeFrame: Birth until discharge from hospital (performed during hospitalization of newborn from 0 to 30 days of life)
measure: Neonatal stay
timeFrame: Birth to newborn discharge home (from day 0 through 120 days of life)
measure: Newborn
timeFrame: At birth
Other outcomes:
Locations:
Study officials:
affiliation: Stony Brook University
name: David J Garry, DO
role: PRINCIPAL_INVESTIGATOR
References:
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