Brief Intervention to Reduce Fear of Public Speaking

New York State Psychiatric Institute

Status and phase

Terminated

Phase 4

Conditions

Social Anxiety Disorder

Treatments

Drug: propranolol

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02790736

7293 (SAD)

Details and patient eligibility

About

The study will test the efficacy of propranolol or placebo, administered after retrieval of a previously acquired public speaking fear, in reducing fear and avoidance of public speaking.

Full description

Twenty subjects with Performance-Only type of Social Anxiety Disorder will be enrolled in the study. Participants will complete baseline assessments of fear and avoidance of public speaking. Participants will be randomly assigned to a single dose of propranolol 40mg or placebo, administered immediately after a fear activation procedure. Primary outcome assessment will be self-reported fear of public speaking and avoidance behavior in a behavioral avoidance task 2 weeks after the intervention.

Enrollment

6 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18-60 years of age at the time of consent
Principal Diagnosis of Social Anxiety Disorder, Performance only type
Has clinically significant fear of public speaking
Physically healthy
If female, non-pregnant and not nursing
Off all psychotropic drug for at least 4 weeks
A level of understanding sufficient to provide written informed consent to all required study tests and procedures.

Exclusion criteria

History of other serious psychiatric disorder
Current Major Depressive Disorder
Presence of developmental disorder or intellectual disability
SAD patients with SAD not of the performance only type
Women who are pregnant or nursing
Current use of psychiatric medication
Current substance use disorder
Persons planning to start another treatment during the study period.
Any significant medical condition that might increase the risk or participation (e.g., seizure disorder, respiratory disorders [e.g., bronchial asthma], cardiovascular disease [e.g., congestive heart failure, heart arrhythmias, sinus bradycardia and greater than first degree block ], low blood pressure [ < 90/60], diabetes, liver or kidney disorders)
Use of medications that might negatively interact with propranolol (e.g., ACE inhibitors; catecholamine depleting drugs, such as reserpine; calcium channel blockers; digitalis glycosides; haloperidol; chlorpromazine; aluminum hydroxide gel; phenytoin; phenobarbitone; rifampin; antipyrine; lidocaine; cimetidine; theophylline)