Opioid-use Disorder Clinical Trial
Official title:
Comparison of Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology
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
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.
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