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Effect of Oxytocin on Craving and Therapy Response

Plain-language guide to NCT01827332: not phased randomized trial of Oxytocin, 16 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01827332
Phase
not phased
Status
completed
Start
2013-03
Completion (planned or actual)
2015-06
Participants
16 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Marijuana Dependence
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Oxytocin.

The purpose of this study is to examine the impact of a medication called oxytocin on marijuana use and therapy response in people who frequently use marijuana.

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

Intranasal administration.

Intranasal administration.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 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 9 exclusion criteria; among the exclusions: subjects with a history of or current psychotic disorder or bipolar affective disorder as these may interfere with subjective measurements; subjects who pose a current suicidal or homicidal risk; subjects with any acute illness or fever. individuals who otherwise meet study criteria will be rescheduled for evaluation for participation.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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 2013-03 with completion listed for 2015-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Therapy Session Satisfaction (as Measured by Subjective Report) (time frame: Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit).

It also tracked 1 secondary outcome, for example Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions ).

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.

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.