Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder

What Was Tested

This registered phase 2, phase 3 trial tested Oxytocin.

Alcohol use disorder (AUD) is a chronic relapsing disorder.

Alcohol craving, a hallmark symptom of AUD that drives relapse in patients, is only insufficiently treated by existing medication.

It had two arms (groups): Oxytocin + Naltrexone (experimental) and Placebo + Naltrexone (active comparator).

The registry classes the interventions as drug.

Who Took Part

62 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age between 18 and 70 years. Patients meeting the diagnosis of an alcohol dependence according to the Internation Clasification of Diseases 10th revision (ICD10). Ability of the individual to understand the character and the individual consequences of the clinical trial. Written informed consent (must be available before enrollment in the study). Consent to random assignment.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: positive drug screening (amphetamines/ecstasy, opiates, cocaine, barbiturates); pregnancy, lactation or breastfeeding; participation in other clinical trials or observation period of competing clinical trials, respectively.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2021-12-02 with completion listed for 2023-07-15.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Alcohol Urge Questionnaire (AUQ).

It also tracked 24 secondary outcomes, for example Alcohol Urge Questionnaire (AUQ), Alcohol Urge Questionnaire (AUQ), Alcohol Urge Questionnaire (AUQ), Alcohol Urge Questionnaire (AUQ), Alcohol Urge Questionnaire (AUQ) and Primary Appraisal secondary Appraisal Scale (PASA).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 62 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.