Stimulant Oxytocin Study

What Was Tested

The trial (phase 2) is built around Oxytocin.

It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).

Patients in MMT programs are required to come in every day for their methadone. Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions. The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring OUD to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.

The registry classes the interventions as drug.

More on the Plan

High rates of substance use disorders (SUDs) in Veterans compared to the general population are heavily influenced by psychosocial factors - such as difficulty reintegrating into civilian life due to avoidance of vital support systems - leading to disproportionately elevated unmet addiction treatment needs.

Administering oxytocin, a mammalian neuropeptide, intranasally to healthy controls facilitates the stress-buffering properties of social support.

Oxytocin may also have an independent role in mitigating the symptoms of SUDs.

A more integrated understanding of oxytocin's distinct effects on the behavior and psychology of 1) addiction, 2) sociality, and 3) stress reactivity could be the key to defining oxytocin's role in SUD treatment.

Who Took Part

42 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: At least 18 years old. Enrolled as a patient who at the SFVAMC Opioid Treatment Program or the Oakland Behavioral Health Clinic Opioid Treatment Program. One documented urine toxicology screen positive for stimulants in the past 12 months.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: severe neuropsychological disorder; suicidal or homicidal ideation within the past 90 days or a suicide attempt in the past 6 months; hemodialysis, unless participant can produce urine samples weekly.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-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, care provider, investigator and outcomes assessor.

It started in 2018-01-26 with completion listed for 2020-02-14.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Stimulant Positive Drug Screen (time frame: Baseline, Visits 1-7, up to 7 weeks).

It also tracked 10 secondary outcomes, for example Working Alliance Inventory (WAI), Heart Rate in Response to Trier Social Stress Test (TSST), Respiratory Rate in Response to Trier Social Stress Test (TSST), Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST), Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST) and Self-reported Stimulant Craving.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 42 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.