Oxytocin in Cocaine Dependence

What Was Tested

The trial (not phased) is built around Oxytocin.

Stress is likely involved in relapse to cocaine use.

This project will investigate the role oxytocin may play in the stress response in cocaine-dependent men and women and examine how oxytocin may impact brain activity in individuals exposed to cocaine-related cues.

It had 12 arms (groups): TSST Women Oxytocin (experimental), TSST Women Placebo (placebo comparator), MRI 1 Women Oxytocin (experimental), MRI 1 Women Placebo (placebo comparator) and MRI 2 Women Oxytocin (experimental).

Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing a Social Stress Task.

Cocaine-dependent women received intranasal saline prior to completing a Social Stress Task.

Cocaine-dependent women received 40 IUs of intranasal oxytocin prior to completing the first of two fMRI cue-exposure tasks.

The registry classes the interventions as drug.

More on the Plan

Stress is an important predictor of relapse, and targeting stress-activated pathways may lead to therapeutic advancements in the treatment of substance use disorders.

However, little is known about the role of oxytocin in mediating the affective response to cocaine-paired cues and associated neural activity in cocaine-dependent men and women.

This project is a direct evolution from their previous SCOR-supported research.

Their work has progressed from characterizing sex/gender differences in response to social stressors and cocaine cues in cocaine-dependent men and women, to their on-going work evaluating whether stress potentiates cue-induced craving and the impact of hormones on this response.

Who Took Part

The registry lists 112 actual participants took part.

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

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

Examples of who could join: 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 a three-day period immediately prior to the throughout study procedures. Subjects must consent to random assignment. Subjects must consent to participating in study procedures at the ASD and completion of two fMRI scans.

The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: women who are currently taking, or have taken in the past month, oral or other types of hormonal contraceptives or hormone replacement therapies; women with premenstrual dysphoric disorder who are outside of the follicular phase; women who have had a complete hysterectomy or are over 50 over one year post-menopausal, as ovarian hormones will be measured in the study.

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.

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 2012-10 with completion listed for 2017-12-19.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Subjective Stress Response TSST (time frame: Subjects rated stress immediately following a Social Stress task on Day 1 of 3). Subjective Stress Response MRI 1 (time frame: Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3). Subjective Stress Response MRI 2 (time frame: Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3).

It also tracked 3 secondary outcomes, for example Subject Cocaine Craving TSST, Subject Cocaine Craving MRI 1 and Subject Cocaine Craving MRI 2.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 112 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.