Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

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

A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session. All participants will receive 12 weekly, 90-minute ABCT therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 192 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: Male or female; any race or ethnicity; aged 18-75 years. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments (\> 26 on the Mini-Mental State Exam). Married, cohabiting, or in a committed relationship for ≥ 6 months.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: participants who present a serious suicide risk or are likely to require hospitalization during the study; severe unilateral intimate partner violence in the past 6 months as defined by the revised conflict tactics scale (cts-2); pregnancy or breastfeeding for women.

How the Study Was Run

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

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

The Oxytocin group and the comparison group ran side by side rather than switching.

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 2019-05-16 with completion listed for 2024-01-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Percent Days Abstinent - Measured by Time Line Follow Back (TLFB) (time frame: Baseline to week 12). Change in Relationship Functioning - Measured by Dyadic Adjustment Scale - Short Form (DAS-7) (time frame: Baseline to week 12). Change in Percent Days Heavy Drinking - Measured by Time Line Follow Back (TLFB) (time frame: Baseline to week 12).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 192 people.

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.