Oxytocin and Cognitive Behavioral Therapy in Drug Dependence

What Was Tested

The trial (phase 4) is built around Oxytocin.

Background: \- The therapeutic alliance between therapist and patient may contribute to favorable outcomes in all types of psychotherapy, including cognitive behavioral therapy (CBT) for drug dependence.

It had three arms (groups): Methadone (placebo comparator), Outpatient Cocaine (placebo comparator) and Inpatient Cocaine (placebo comparator).

Intranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients.

Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients.

Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients.

The registry classes the interventions as behavioral and drug.

More on the Plan

Objective The therapeutic alliance (TA), a working relationship between therapist and patient, may contribute to favorable outcomes in all types of psychotherapy, including cognitive-behavioral therapy (CBT) for drug dependence.

The study will assess changes in performance on tasks that probe decision-making, emotional processing, and drug-cue reactivity.

The researchers will employ fMRI on a subset of participants to study the neural correlates of these processes.

There will also be two groups of non-treatment-seeking controls (20 cocaine-using, 20 non-drug-using) to rule out practice effects on tasks; controls will not receive oxytocin or CBT.

Who Took Part

Enrollment: 63 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Be between age 18 and 65. Methadone arm only: opiate dependence for the past year determined by clinical exam, opiate-positive urine during screening and diagnosis confirmed by SCID. Cocaine outpatient arm: cocaine dependence determined by clinical exam, cocaine-positive urine during screening and diagnosis confirmed by SCID. Cocaine inpatient arm: Cocaine dependence determined by clinical exam during screening and diagnosis confirmed by SCID.

The full record lists 9 inclusion and 23 exclusion criteria; among the exclusions: schizophrenia or any other dsm-iv psychotic disorder; history of bipolar disorder; current major depressive disorder; current dependence on alcohol or sedative-hypnotic, e.g. benzodiazepine (by dsm-iv criteria), except for inpatient cocaine arm; cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires.

How the Study Was Run

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

It started in 2008-11 with completion listed for 2013-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Therapeutic Alliance (time frame: Post 12 weeks treatment with cognitive behavioral therapy).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 63 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.