Not Yet RecruitingPhase 2ACTRN12611000434998

Intranasal Oxytocin and the exploration of eye gaze in people who stutter.

A randomised controlled trial to explore the effects of oxytocin/placebo on eye gaze in adults who stutter.

Sponsor

University of Sydney

Enrollment

40 participants

Start Date

May 9, 2011

Study Type

Interventional

Conditions

Stuttering

Summary

The goal of this study is to examine the effect of Oxytocin (OT) in facilitating eye gaze during a speaking task in adults who stutter. Participants who stutter will be randomized to receive 24UI intranasal OT or placebo before giving a speech to a pre-recorded audience. The aim of the procedure is to assess whether participants who receive OT before delivering the speech show a difference in eye gaze than the placebo group. It is predicted that the experimental participants who receive OT will demonstrate increased gaze towards audience members compared with the participants in the placebo group and thus increase access to important social information from the interaction. Secondly the experimental group is hypothesized to report less fear and anxiety following the procedure than the placebo group.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 75 Yearss

Inclusion Criteria3

Male adults who stutter
Onset of stuttering before 12 years of age
No treatment for stuttering or anxiety conditions within 6 months preceding the experimental procedure

Exclusion Criteria10

Onset of stuttering at age 12 years or older
Onset of stuttering due to a known conversion or any other psychological disorder
Presence of a complicating disorder (e.g., developmental delay, autism, Down’s Syndrome, cerebral palsy etc.)
Currently taking ‘psychological’ medication
Severe Depression with suicidal thoughts and/ or actions
Severe Cardiovascular problems (e.g., heart disease, history of heart attacks)
Kidney Disease- (i.e., kidney stones, recurrent bladder infections, or known kidney failure)
Psychosis (i.e., bizarre beliefs that do not represent reality; sensations without any sensory input- hearing, smelling seeing, feeling things that don’t exist.
Drugs: Smoking more than 15 cigarettes a day or addicted to other illegal substances.
Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)

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Interventions

In a randomised controlled trial participants who stutter will be randomly assigned to receive a single administration (24 international units) of intranasal Oxytocin (Syntocinon) or a placebo nasal spray before presenting a 3 minute speech. This speech will be made to a pre-recorded audience of strangers who were trained to display positive, neutral or negative expressions.