Overview

Oxytocin, Stress, Craving, Opioid Use Disorder

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brown University
Treatments:
Oxytocin
Criteria
Inclusion Criteria:

- Male or female (50%), 18 to 65 (inclusive) years of age;

- Currently meets DSM-5 criteria for OUD;

- Currently on a stable dose of buprenorphine/naloxone for at least 3 months;

- In good health as confirmed by medical history, physical examination and blood work
(AST/ALT; bilirubin, creatinine clearance within normal limit);

- 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 Criteria:

- 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.