Brief Intervention to Reduce Fear of Public Speaking

NCT02790736 | Terminated Phase 4 Results

• 1 other identifier: 7293 (SAD)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

propranolol; public speaking anxiety

Outcome Measures

Primary Outcomes (1)

• Personal Report of Confidence as a Speaker

  total score on this self report measure of fear of public speaking. Scored from 0-30, with higher scores indicating better outcome

  2 weeks

Secondary Outcomes (1)

• Behavioral Avoidance Task

  2 weeks

Study Arms (2)

Propranolol

EXPERIMENTAL

Propranolol 40 mg capsule, given once after fear activation procedure

Drug: propranolol

placebo capsule

PLACEBO COMPARATOR

Placebo capsule, given once after fear activation procedure

Drug: Placebo

Interventions

propranolol DRUG

active treatment

Also known as: Innopran XL

Propranolol

Placebo DRUG

inactive pill

Also known as: Placebo Oral Tablet

placebo capsule

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute, 1051 Riverside Drive

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Propranolol; propranolol CR

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Early termination of this pilot study leading to small numbers of subjects evaluated

Results Point of Contact

• Title: Franklin Schneier MD
• Organization: NY State Psychiatric Institute

fschneier@nyspi.columbia.edu

6467748041

Study Officials

• Franklin Schneier, MD

  NYSPI

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 6, 2016
• Study Start: June 1, 2016
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: June 7, 2023
• Results First Posted: September 5, 2018

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)