Neural Substrates of Emotion: Impact of Cocaine Dependence

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

Over one million individuals in the United States meet criteria for cocaine use disorders.

Relapse rates are highest among cocaine-dependent (CD) populations.

It had four arms (groups): Oxytocin/Cocaine User (experimental), Placebo/Cocaine User (active comparator), Oxytocin/Control (experimental) and Placebo/Control (active comparator).

Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin.

Individuals who meet criteria for cocaine use disorder and are randomized to placebo.

Healthy controls who are randomized to oxytocin.

The registry classes the interventions as drug.

More on the Plan

Individuals will be screened for eligibility over the telephone by a trained research assistant during which major inclusion/exclusion criteria will be assessed.

Individuals who appear eligible will be invited for an in-person interview with a member of the research team.

Prior to any study procedures, the individual will sign an Institutional Review Board (IRB) approved informed consent form.

Following consent, a battery of standardized assessments will be delivered (described below).

Who Took Part

Enrollment: 138 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

The full record lists 0 inclusion and 19 exclusion criteria; among the exclusions: age 18-65; subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments; subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for the three-day period immediately prior to the study visit.

How the Study Was Run

Design: randomized, parallel-group and triple-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.

The Oxytocin group and the comparison group ran side by side rather than switching.

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, investigator and outcomes assessor.

It started in 2015-07 with completion listed for 2020-07-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Functional Connectivity Between Corticolimbic Brain Regions During Acute Social Stress (time frame: During Montreal Imaging Stress Task in fMRI scanner). Amygdala Activity in Response to Fearful Faces (time frame: During Facial Recognition Task in fMRI scanner).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 138 people.

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.