Status:
COMPLETED
Oxytocin, Stress, Craving, Opioid Use Disorder
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed 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 effectiv...
Eligibility Criteria
Inclusion
- Male or female (50%), 18 to 70 (inclusive) years of age;
- Currently meets DSM-5 criteria for OUD;
- Currently on a stable dose of buprenorphine/naloxone or methadone for at least 3 months;
- In good health as confirmed by medical history, physical examination and blood work (Liver function within 5x the Upper normal limits (AST/ALT) and renal function within 2x the Lower Normal Limit (bilirubin, creatine clearance).
- Willing to take medication and adhere to the study procedures;- Understand informed consent and questionnaires in English at an 8th grade level;
- Clinical Opiate Withdrawal Scale (COWS) = 0 at study screening and prior laboratory sessions.
Exclusion
- Women who are breastfeeding, test positive for pregnancy or are unwilling to use medically-approved birth control;
- Suicide attempts in the last three months;
- Current substance disorder other than marijuana, nicotine and caffeine as assessed by self-report and urine toxicology screen at baseline;
- Current use of medications that may interact with study medications;
- History of hypersensitivity to study medications;
- Clinically significant electrolyte abnormalities, current rhinitis or use of vasoconstricting medications or prostaglandins.
Key Trial Info
Start Date :
January 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04051619
Start Date
January 6 2020
End Date
December 23 2023
Last Update
May 25 2025
Active Locations (1)
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1
Brown University
Providence, Rhode Island, United States, 02291