Methadone Oxytocin Option

What Was Tested

The trial (early phase 1) is built around Oxytocin.

The purpose of the study is to examine the effects of intranasal oxytocin administration on social cognition in patients receiving methadone maintenance treatment (MMT), examine the effects of intranasal oxytocin administration on opioid craving and on the subjective effects of methadone, and examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in patients receiving MMT.

Hypothesis 1: Patients will perform better on measures of social cognition (including affect recognition and recognition of sarcasm) after administration of oxytocin compared with placebo.

It had two arms (groups): Oxytocin (experimental) and Saline Nasal Spray (placebo comparator).

Placebo Comparator.

The registry classes the interventions as drug.

Who Took Part

64 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Primary diagnosis of opioid dependence according to DSM-IV TR. Opioid of choice be either heroin or oral opioid analgesics. No diagnosis of mental disorder according to DSM-IV TR.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: current illicit drug use (within the past one month); current sever depression with suicidal thoughts and/or actions; addiction to alcohol or drugs other than opiates, caffeine, or nicotine.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2012-05 with completion listed for 2014-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Computerized Social Cognition Tasks (time frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart).

It also tracked 1 secondary outcome, for example Craving Questionnaires.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 64 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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