Oxytocin Treatment of Opioid Dependence

What Was Tested

This registered phase 1, phase 2 trial tested Oxytocin.

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.

It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).

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

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

The registry classes the interventions as drug.

More on the Plan

Oxytocin is made naturally and is released in parts of the brain where it acts like a chemical signal from one cell to another.

Oxytocin is approved by the Food and Drug Administration for stimulating labor in pregnant women but is not approved as a treatment for opioid dependence.

People who use large amounts of opioids every day or many days per week for weeks or months undergo chemical changes in their brains.

Treatment assignments will be random within each sex.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 21 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Regular opioid use (daily or nearly daily) for at least 6 months (subjective report). Active DSM-IV diagnosis of opioid dependence.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2016-02 with completion listed for 2016-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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).

It also tracked 3 secondary outcomes, for example AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 5 Inclusive, AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 5 Inclusive and Speilberger State and Trait Anxiety Inventory.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.