Phase 1
N=20
Oxytocin, Stress, Craving, Opioid Use Disorder
Opioid Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04051619 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Opioid Craving — 21.6; 22.4; 23.3; 23.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- intranasal oxytocin, 40 IU, twice a day for 7 days (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Craving |
21.6; 22.4; 23.3; 23.4; 22.9; 23.0 | — |
| SECONDARY Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Opiate Withdrawal Syndrome |
1.2; 0.8; 1.8; 3.0; 1.0; 1.3 | — |
| SECONDARY Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Anxiety |
1.8; 2.5; 2.0; 2.7; 1.9; 2.7 | — |
| SECONDARY Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Systolic Blood Pressure (SBP) |
127.9; 124.2; 134.2; 137.2; 133.4; 147.2 | — |
| SECONDARY Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Heart Rate (HR) |
83.0; 80.0; 75.5; 83.1; 74.6; 77.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT04051619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.