Oxytocin Treatment of Opioid Dependence

NCT02548728 | Completed Phase 1 Results

• 1 other identifier: 14-3041
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Dependence; Opioid Withdrawal

Keywords

Opioid Dependence; Opioid Withdrawal; Opioid; Oxytocin; OT (oxytocin); Intranasal administration

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) in COWS Total Score on Days 1 to 5 Inclusive

  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.

  From days 1-5, the measure includes scores starting at time 0 through the maximal final time of up to 120 hours.

Secondary Outcomes (3)

• AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 5 Inclusive

  5 days

• AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 5 Inclusive

  Days 1-5, the AUC includes data starting from time 0 hours up to 120 hours post-dose.

• Speilberger State and Trait Anxiety Inventory

  Daily up to 5 days

Study Arms (2)

Oxytocin

EXPERIMENTAL

Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days.

Drug: Intranasal Oxytocin Spray

Placebo

PLACEBO COMPARATOR

Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days.

Drug: Placebo

Interventions

Intranasal Oxytocin Spray DRUG

10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days

Also known as: Syntocinon spray

Oxytocin

Placebo DRUG

10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21-45.
• Regular opioid use (daily or nearly daily) for at least 6 months (subjective report).
• Active DSM-IV diagnosis of opioid dependence.

You may not qualify if:

• Meets DSM-IV criteria for dependence on psychoactive substances other than opioids, caffeine or nicotine within 6 months prior to screening.
• Treatment with naltrexone in the last month.
• Serum sodium \< 136 mEq/L (i.e., below the normal range) at the time of screening.
• Significant abnormal findings on physical examination.
• Women who are pregnant or breastfeeding.
• In the judgment of the investigators, the individual would be considered a poor candidate.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Cort Pedersen, MD
• Organization: University of North Carolina at Chapel Hill

cort_pedersen@med.unc.edu

919-923-3284

Study Officials

• Cort A Pedersen, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• James C Garbutt, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: September 14, 2015
• Study Start: February 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 7, 2019
• Results First Posted: August 7, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)