Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04051619 · ClinicalTrials.gov registry record · Phase 1
Oxytocin, Stress, Craving, Opioid Use Disorder
A Phase 1 study, sponsored by Brown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04051619: Completed Phase 1 study, sponsored by Brown University.
NCT04051619 is a Phase 1 study that has completed, run by Brown University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04051619, a Phase 1 study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome will test the effect of oxytocin, compared to placebo, on opioid craving during two laboratory stress induction, paired to a cue reactivity paradigm. The dependent measure for the primary aim is the Desire for Drug Questionnaire (DDQ). The stress induction will be done using yohimbine or matching placebo (counterbalanced) during the two laboratory sessions. At each visit the DDQ will be administered 3 times: before starting any procedure, after the yohimbine challenge, and a
Interventions
- DRUG intranasal oxytocin, 40 IU, twice a day for 7 days
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-01-06 |
| Est. Completion | 2023-12-23 |
| Phase | Phase 1 |
What the finished NCT04051619 record still lists
NCT04051619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which intranasal oxytocin, 40 IU, twice a day for 7 days is the first listed.
NCT04051619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04051619 about?
NCT04051619 is a clinical study titled "Oxytocin, Stress, Craving, Opioid Use Disorder". 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 t...
What is the current status of trial NCT04051619?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-01-06. Estimated completion is 2023-12-23.
What interventions are being tested in trial NCT04051619?
The interventions under investigation include: intranasal oxytocin, 40 IU, twice a day for 7 days (DRUG).
Who is sponsoring clinical trial NCT04051619?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04051619's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI