Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.

What Was Tested

This registered phase 2, phase 3 trial tested Oxytocin.

This proposal describes a combined laboratory and clinical trial preliminary investigation to advance medication development for cocaine dependence.

To measure the stress sensitivity, this study will evaluate a new stress challenge: a) Intranasal desmopressin, a vasopressin analog, will be used an endocrine stressor; its effects will be evaluated by serial measurements of serum Adrenocorticotropin hormone (ACTH), and self reports; b) if pretreatment with intranasal oxytocin dampens the ACTH and subjective response to intranasal desmopressin.

It had two arms (groups): Placebo (placebo comparator) and Intranasal Syntocinon (active comparator).

Solution containing only the excipients of the original solution without Oxytocin.

The registry classes the interventions as drug.

More on the Plan

Intranasal administration provides a convenient method to deliver these small peptides to the brain.

Studying the feasibility of this approach, and its applicability to the treatment of cocaine-dependent patients, will be a goal of the study.

The main outcome of this study will be the number of consecutive days of abstinence from cocaine after abstinence induction.

Who Took Part

43 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Age 18 to 60. Meet DSM-IV criteria for current cocaine dependence and is seeking treatment. Displays at least one cocaine-positive urine toxicology during screening. Able to give informed consent and comply with study procedures. Can pass the blindfolded scent test recognizing the scent of cinnamon or coffee.

The full record lists 6 inclusion and 19 exclusion criteria; among the exclusions: history of allergy or adverse event related to oxytocin or desmopressin. patient using oxytocin or vasopressin-based products cannot participate; chronic organic mental disorder, insufficient proficiency in english, or any condition or status (illiteracy) that would render an individual incapable of giving informed consent; coronary vascular disease as indicated by history, or suspected by abnormal ecg.

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and investigator.

It started in 2015-03 with completion listed for 2018-02-14.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weeks of Abstinence From Cocaine (time frame: Phase 1: 7 days; Phase 2: 6 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 43 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.