Oxytocin, Stress, Craving, Opioid Use Disorder

What Was Tested

In this phase 1 trial, researchers set out to test Oxytocin.

Although stress has long been linked to substance use, craving and relapse, there are no available medications that target stress-induced substance use disorder (SUD).

It had two arms (groups): Oxytocin first, then placebo (experimental) and Matching placebo, then oxytocin (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

This hypothesis is based on the model of addiction (Koob, Neuron 2008) in which chronic substance use and stress lead to neurobehavioral counter-adaptations that dysregulate biobehavioral response.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Currently meets DSM-5 criteria for OUD;. Willing to take medication and adhere to the study procedures;- Understand informed consent and questionnaires in English at an 8th grade level;. Clinical Opiate Withdrawal Scale (COWS) = 0 at study screening and prior laboratory sessions.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: suicide attempts in the last three months;; current substance disorder other than marijuana, nicotine and caffeine as assessed by self-report and urine toxicology screen at baseline;; current use of medications that may interact with study medications;.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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.

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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, care provider, investigator and outcomes assessor.

It started in 2020-01-06 with completion listed for 2023-12-22.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Opioid Craving.

It also tracked 4 secondary outcomes, for example Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Opiate Withdrawal Syndrome, Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Anxiety, Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Systolic Blood Pressure (SBP) and Safety and Tolerability of Oxytocin and Yohimbine in OUD Individuals Receiving Opioid Agonist Therapy: Heart Rate (HR).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 20 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.