Brief Intervention to Reduce Fear of Public Speaking

NCT ID: NCT02790736

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-10-30

Brief Summary

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.

Detailed 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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Propranolol

Propranolol 40 mg capsule, given once after fear activation procedure

Group Type: EXPERIMENTAL

propranolol

Intervention Type: DRUG

active treatment

placebo capsule

Placebo capsule, given once after fear activation procedure

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

inactive pill

Interventions

propranolol

active treatment

Intervention Type: DRUG

Placebo

inactive pill

Intervention Type: DRUG

Other Intervention Names

Innopran XL; Placebo Oral Tablet

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Franklin Schneier

Research Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franklin Schneier, MD

Role: STUDY_DIRECTOR

NYSPI

Locations

New York State Psychiatric Institute, 1051 Riverside Drive

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

7293 (SAD)

Identifier Type: -

Identifier Source: org_study_id

NCT02924610

Identifier Type: -

Identifier Source: nct_alias