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NCT02548728 · ClinicalTrials.gov registry record · Phase 1

Oxytocin Treatment of Opioid Dependence

A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT02548728: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

NCT02548728 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02548728, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

Purpose: The purpose of this research study is to learn whether oxytocin treatment decreases use of and cravings for opioids (narcotics) in people who have been using opioids heavily for long periods of time and are unable to stop on their own. Participants: Patients meeting DSM-IV-TR criteria for opioid dependence. Procedures (methods): Subjects will have standard medications available for withdrawal symptoms from opioids and standard psychosocial interventions available in the inpatient setting. In addition, subjects will self-administer intranasal test treatments 3 times daily.

Primary Outcome

The Clinical Opiate Withdrawal Scale (COWS) is an 11-item, observer-rated tool for quantifying withdrawal symptoms. Each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points). Lower scores are more favorable.

Interventions

  • DRUG Placebo
  • DRUG Intranasal Oxytocin Spray

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2016-02
Est. Completion 2016-12
Phase Phase 1

What the finished NCT02548728 record still lists

NCT02548728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02548728 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02548728 about?

NCT02548728 is a clinical study titled "Oxytocin Treatment of Opioid Dependence". Purpose: The purpose of this research study is to learn whether oxytocin treatment decreases use of and cravings for opioids (narcotics) in people who have been using opioids heavily for long periods of time and are unable to stop on their own. Participants: Patients meeting DSM-IV-TR criteria for ...

What is the current status of trial NCT02548728?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2016-02. Estimated completion is 2016-12.

What interventions are being tested in trial NCT02548728?

The interventions under investigation include: Placebo (DRUG), Intranasal Oxytocin Spray (DRUG).

Who is sponsoring clinical trial NCT02548728?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02548728's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 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

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Source: ClinicalTrials.gov NCT02548728, the US trial registry maintained by the National Library of Medicine. NCT02548728 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.