Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Oxytocin Treatment of Opioid Dependence

NCTNCT02548728Other id14-3041

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1/2
Enrollment: 12 participants (actual)
Sponsor: University of North Carolina, Chapel Hill · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Feb 2016
Primary completion: Dec 2016
Completion: Dec 2016
First posted: 14 Sept 2015 (estimated)
Last update posted: 7 Aug 2019
Conditions: Opioid Dependence · Opioid Withdrawal

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20162017

Ph 1/2
Oxytocin Treatment of Opioid Dependence
NCT02548728
Feb 2016 to Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Intranasal Oxytocin SprayDrug
PlaceboDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Area Under the Curve (AUC) in COWS Total Score on Days 1 to 5 Inclusive
Time frame · From days 1-5, the measure includes scores starting at time 0 through the maximal final time of up to 120 hours.
Registry description
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.

Secondary outcomes(3)

AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 5 Inclusive
Time frame · 5 days
Registry description
Least squares mean AUC day 1 pre-dose through Day 5 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable
AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 5 Inclusive
Time frame · Days 1-5, the AUC includes data starting from time 0 hours up to 120 hours post-dose.
Registry description
Craving levels were measured using the VAS score on Days 1 to 5; the VAS scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had"). Note that the value of AUC is a product of time multiplied by VAS scale score thus the numeric values are higher than the highest value on the scale.
Speilberger State and Trait Anxiety Inventory
Time frame · Daily up to 5 days
Registry description
The Spielberger State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The State scale consists of 20 questions, each question rated 1-4, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

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

Group	Value (Average COWS score * hours)	Spread
Oxytocin	4.2	1.5
Placebo	3.4	1.5

Secondary and other outcome results(3)

Secondary outcome· 5 days

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

Group	Value
Oxytocin	not posted
Placebo	not posted

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

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

Group	Value (Average VAS score * hours)	Spread
Oxytocin	1498	839
Placebo	2037	2253

Secondary outcome· Daily up to 5 days

Speilberger State and Trait Anxiety Inventory

Group	Value
Oxytocin	not posted
Placebo	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
OxytocinSelf administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days. Intranasal Oxytocin Spray: 10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days	0 / 6	1 / 6	5 / 6
PlaceboSelf administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days. Placebo: 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	0 / 6	0 / 6	6 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 45 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Age 21-45. 2. Regular opioid use (daily or nearly daily) for at least 6 months (subjective report). 3. Active DSM-IV diagnosis of opioid dependence. Exclusion Criteria: 1. Meets DSM-IV criteria for dependence on psychoactive substances other than opioids, caffeine or nicotine within 6 months prior to screening. 2. Treatment with naltrexone in the last month. 3. History of a significant psychiatric illness including: lifetime history of mania requiring hospitalization, psychotic disorder, cognitive disorder; history during the last two years of eating disorder. Standing or as needed non-exclusionary medications for non-exclusionary psychiatric disorders will be permitted. 4. Unstable medical illness that could compromise consent to treatment, interfere with evaluation of study medication, or present a safety concern (e.g. uncontrolled diabetes mellitus, unstable hypertension, BMI \<18 or \>35, seizure disorder, traumatic brain injury, Parkinson's disease, AIDS). Adequately controlled conditions (such as diabetes mellitus, hypertension, asthma, HIV infection, and hepatitis C) will not be exclusionary. Standing or or as needed medications for non-exclusionary medical conditions will be permitted. 5. Serum sodium \< 136 mEq/L (i.e., below the normal range) at the time of screening. 6. Significant abnormal findings on physical examination. 7. Women who are pregnant or breastfeeding. 8. In the judgment of the investigators, the individual would be considered a poor candidate.

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