NCT03740243

Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stony Brook University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Buprenorphine/naloxone	Buprenorphine/naloxone tablet or film
DRUG	Buprenorphine	Buprenorphine tablet

Timeline

• Start date: 2018-11-30
• Primary completion: 2020-03-22
• Completion: 2020-03-22
• First posted: 2018-11-14
• Last updated: 2020-03-24

Regulatory

• FDA-regulated drug study