Oxytocin, Stress, Craving, Opioid Use Disorder
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 80
Summary
- Conditions
- Opioid Use Disorder
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04051619
- Collaborators
- Not Provided
- Investigators
- Not Provided