Oxytocin HIV Meth Study

What Was Tested

In this phase 1 trial, researchers set out to test Oxytocin.

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

The registry classes the interventions as drug.

More on the Plan

Currently no psychopharmacological agent exists for the treatment of AUD; innovative interventions are desperately needed.

In other populations, oxytocin's effects are known to vary depending on social context.

The investigators propose a randomized, double-blind pilot study of psychopharmacological-psychosocial combination therapy, administration of intranasal oxytocin versus placebo prior to six Motivational Interviewing Group Therapy (MIGT) sessions, in 28 mixed HIV sero-status MSM initiating treatment for AUD.

Who Took Part

48 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

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

Examples of who could join: One documented urine toxicology screen positive for meth in the past month. Considering initiating treatment for Methamphetamine Use Disorder or initiated treatment within the past month. History of sexual contact with men.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: urine toxicology screen positive for heroin in the past month; hemodialysis or inability to produce urine samples; sensitivity to: e 216, e 218, and chlorobutanol hemihydrate (preservatives used in nasal spray).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-01 with completion listed for 2018-07.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Side effect profile (time frame: 6 weeks).

It also tracked 6 secondary outcomes, for example Recruitment Rates, urine toxicology, Meth Craving Questionnaire-Brief (MCQ-Br), attendance rate, Group Questionnaire and heart rate variability.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 48 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.