Effects of Intranasal Oxytocin in the Treatment of Benzodiazepine Withdrawal: A Pilot RCT

What Was Tested

This registered phase 2 trial tested Oxytocin.

It will also learn about the safety of oxytocin.

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

The registry classes the interventions as drug.

More on the Plan

Background Benzodiazepine withdrawal can be challenging, often accompanied by severe anxiety, insomnia, and other withdrawal symptoms.

Secondary objectives include evaluating the safety and tolerability of intranasal OT and its impact on anxiety levels and sleep quality.

Screening: Eligible participants underwent a screening process, including medical history, physical examination, and baseline assessments. 2.

Randomization: Participants were randomly assigned to the OT or placebo group. 3.

Who Took Part

Enrollment: 66 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.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

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 2022-03-01 with completion listed for 2025-11-06.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Benzodiazepine withdrawal symptoms (time frame: 21 days).

It also tracked 4 secondary outcomes, for example Benzodiazepine craving, Benzodiazepine anxiety and depression symptoms, Benzodiazepine sleep distress and Benzodiazepine tapering "freezes".

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 66 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.