Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting (OT-PT)

MacDonald, Kai, M.D.

Status and phase: Completed; Phase 4

Conditions: Behavior; Anxiety

Treatments: Drug: Placebo then intranasal oxytocin; Drug: Intranasal oxytocin then placebo

Study type: Interventional

Identifiers

NCT01081249

UCSD IRB 080953

Details and patient eligibility

About

Subjects-currently in outpatient mental health care--will participate in 2 psychotherapy sessions, one with oxytocin spray and one with placebo spray. Sessions will be videotaped, and cortisol and heart rate will be measured. We hypothesize that oxytocin will have positive benefits on nonverbal behavior in the therapy session, as well as have positive effects on subjective anxiety, cortisol and heart rate.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• in current mental health treatment
• male 18-65

Exclusion criteria

• diagnosis of schizophrenia or psychosis
• diagnosis of autism or Aspergers disorder
• active substance use disorder
• at moderate or high risk of self-harm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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18 participants in 2 patient groups

Placebo then Oxytocin

Experimental group

Description:

Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.

Treatment:

Drug: Placebo then intranasal oxytocin

Oxytocin then placebo

Experimental group

Description:

Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.

Treatment:

Drug: Intranasal oxytocin then placebo