Use of Intranasal Oxytocin During Detoxification of Crack Cocaine

What Was Tested

This registered phase 1, phase 2 trial tested Oxytocin.

A total of 84 women were randomly assigned to one of three groups: usual treatment plus oxytocin nasal spray (30 participants), usual treatment plus placebo nasal spray (29 participants), or usual treatment alone (25 participants).

Participants receiving a nasal spray and the staff administering it did not know whether it contained oxytocin or placebo.

It had three arms (groups): Conventional Treatment Plus Intranasal Oxytocin (OXT) (experimental), Conventional Treatment Plus Intranasal Placebo (PBO) (placebo comparator) and Conventional Treatment Alone (CON) (active comparator).

Participants received conventional inpatient treatment alone, without intranasal oxytocin or placebo. Conventional treatment included individual and group supportive psychotherapy once weekly, nutritional care, regular physical activity, nursing care, and psychopharmacotherapy as clinically indicated to manage withdrawal-related symptoms, including anxiety, aggression, and agitation. The planned inpatient treatment period was 21 days.

The registry classes the interventions as drug and other.

More on the Plan

It was conducted in a tertiary inpatient unit in Porto Alegre, Brazil.

Eligible participants who provided informed consent were randomly allocated to conventional treatment plus intranasal oxytocin, conventional treatment plus intranasal placebo, or conventional treatment alone.

The placebo comparison evaluated the additional effects of oxytocin, while the conventional-treatment-only group provided a reference for symptom changes during usual inpatient care.

All groups received conventional inpatient treatment, including psychosocial interventions, nutritional care, physical activity, nursing care, and psychopharmacotherapy as clinically indicated.

Who Took Part

The registry lists 84 actual participants took part.

It was open to women only aged from 18 years up to 52 years.

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

Examples of who could join: Female participants aged 18 to 52 years. Primary diagnosis of cocaine use disorder according to DSM-5 criteria. Other co-occurring substance use disorders were permitted, provided that cocaine was the primary drug of choice. Abstinence from cocaine for at least seven days before the intervention. Provision of informed consent and willingness to undergo random allocation to one of the study groups.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: HIV-positive status; pregnancy, postpartum status, or breastfeeding; current moderate or severe psychotic syndrome.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

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 2018-09-17 with completion listed for 2020-01-12.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Cocaine Withdrawal Symptoms (time frame: Baseline (first week after hospital admission) and end of inpatient detoxification (up to hospital day 21)). Change in Anxiety Symptoms (time frame: Baseline (first week after hospital admission) and end of inpatient detoxification (up to hospital day 21)). Change in Depressive Symptoms (time frame: Baseline (first week after hospital admission) and end of inpatient detoxification (up to hospital day 21)).

It also tracked 2 secondary outcomes, for example Percentage of Participants Enrolled in Outpatient Treatment at Six Months.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 84 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.