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Intranasal Oxytocin for Methamphetamine Withdrawal in Women
Plain-language guide to NCT05760807: not phased interventional trial of Oxytocin, 10 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05760807
- Phase
- not phased
- Status
- completed
- Start
- 2023-03-29
- Completion (planned or actual)
- 2024-03-28
- Participants
- 10 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Methamphetamine Use Disorder
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Oxytocin.
In 2016/17 there were 49,670 Australian treatment episodes for MUD, the first step of which typically involves inpatient withdrawal.
Currently there are no approved medications to help manage methamphetamine withdrawal and consequently many people drop out of treatment prematurely, leaving them vulnerable to relapse.
It had 1 arm (groups): Intranasal oxytocin (experimental).
The registry classes the interventions as drug.
Who Took Part
10 actual participants took part.
It was open to women 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: Meeting DSM-5 criteria for Methamphetamine Use Disorder, moderate or severe (assessed by treating physician on pre-admission to residential withdrawal). Able to comply with study protocols. Able to provide informed consent to participate.
The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: non-english-speaking women; meeting dsm-5 criteria for moderate-severe substance use disorder other than methamphetamine, nicotine and cannabis, as assessed by treating physician on pre-admission to residential withdrawal; current participation in another trial.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2023-03-29 with completion listed for 2024-03-28.
It ran at 1 site in Australia.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Feasibility assessment (time frame: Screening to Admission Day 1).
It also tracked 13 secondary outcomes, for example Length of stay in the inpatient withdrawal unit, Methamphetamine withdrawal symptom severity, Methamphetamine craving, Sleep dysfunction, Mood disturbance and Methamphetamine relapse.
What This Means in Plain Language
Put simply, this is a not phased trial of Oxytocin in 10 people.
Its size is small, so on its own it can only give an early look.
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.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.