Effect of Oxytocin on Stress in Marijuana Users

What Was Tested

The trial (not phased) is built around Oxytocin.

The purpose of this study is to evaluate how people who frequently use marijuana respond to a stressful task, and if a medication (oxytocin) affects this response.

It had two arms (groups): Oxytocin (active comparator) and saline (placebo comparator).

Intranasal administration.

Intranasal administration.

The registry classes the interventions as drug.

More on the Plan

Several studies indicate that hypothalamic neuropeptides may mediate behavioral response to stress.

For example, preclinical and clinical investigations have indicated that the neuropeptide oxytocin exerts anxiolytic effects in stress paradigms.

Several studies have indicated that oxytocin promotes trust, social bonding, and calmness; however, little is known about the potential anxiolytic affects of oxytocin in marijuana-dependent individuals.

This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in marijuana-dependent individuals.

Who Took Part

The registry lists 16 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 random assignment.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: subjects with addison's disease, cushing's disease or other diseases of the adrenal cortex likely to affect hormonal/neuroendocrine status; subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements; subjects receiving synthetic glucocorticoid therapy, any exogenous steroid therapy, or treatment with other agents that interfere with hormonal measurements within one month of test session.

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.

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 and investigator.

It started in 2011-03 with completion listed for 2012-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Stress (as Measured by Cortisol) (time frame: 5 minutes following Trier Social Stress Task completion). Stress (as Measured by Subjective Report) (time frame: 5 minutes following Trier Social Stress Task completion).

It also tracked 1 secondary outcome, for example Craving (as Measured by the Marijuana Craving Questionnaire).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 16 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.