Last updated on February 2020

Oxytocin Stress Craving Opioid Use Disorder

Brief description of study

Although stress has long been linked to substance use, craving and relapse, there are no available medications that target stress-induced substance use disorder (SUD). In particular, with the rise in opioid use, there is still a crucial need for developing effective pharmacological treatments that target and integrate the complexity of this disease. The long term goal of this project is to identify the key neuroendocrine pathways that are responsible for stress-induced craving in individuals with opioid use disorder (OUD) in order to better understand how they can be effectively treated.

Detailed Study Description

The goal of this research is to evaluate whether oxytocin, a hormone with anti-stress properties, dampens the effects of stress and opioid-associated cues on opioid craving and thus may be an effective adjunctive treatment for OUD.

The central hypothesis of this research is that oxytocin will reduce stress-induced opioid craving in patients with OUD treated with buprenorphine/naloxone as opioid replacement therapy (ORT). This hypothesis is based on the model of addiction (Koob, Neuron 2008) in which chronic substance use and stress lead to neurobehavioral counter-adaptations that dysregulate biobehavioral response.

In this double-blind, placebo controlled, randomized trial, individuals with OUD (N=68) who are currently receiving treatment with buprenorphine/naloxone will be randomized to intranasal oxytocin (40 international units, IU) or oxytocin-matched placebo, administered twice/day for 7 days. On days 5 and 7, participants will complete two counter-balanced sessions in which they receive yohimbine (32.4 mg) or yohimbine-matched placebo, and responses to opioid cues are assessed.

Clinical Study Identifier: NCT04051619

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Brown University

Providence, RI United States
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Recruitment Status: Open

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