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Generalization of Extinction Learning

Primary Purpose

Social Anxiety Disorder

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Scopolamine

intranasal placebo

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring exposure, scopolamine, extinction learning, social anxiety

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

between the ages of 18 and 55,
fluent in English,
within normal body weight (BMI=18.5 to 24.9)
meet DSM-IV diagnostic criteria for Social Phobia and report a fear of public speaking.

Exclusion Criteria:

participant report of a diagnosed medical or neurological disorder
prescription or over the counter medications that can interact with Scopolamine, such as anticholinergic medications (e.g. belladonna alkaloids, antihistamines, meclizine, tricyclic antidepressants, and muscle relaxants), cold medicines, cough suppressants. Other drugs that will be reasons for exclusion include: antimuscarinics, nifedipine, parasympathomimetics, amantadine, amoxapine, antacids, antidiarrheals, anxiolytics, hypnotics, atomexetine, bupropion, cisapride, clozapine, cyclobenzaprine, digoxin, disopyramide, dronabinol (THC), ethanol, maprotilline, memantine, metoclopramide, nabilone, olanzapine, opiate agonists, orphenadrine, phenothiazines, potassium salts, quinidine, sedating H1-blockers, topiramate, tricyclic antidepressants, erthyromycin, ketoconazole, and tegaserod.
over the counter drugs or substances that may have a sedative effect (e.g. herbal sedatives: ashwagandha, Duboisia hopwoodii, Prostanthera striatiflora, kava, mandrake, valerian, cannabis, passiflora incarnate; Antihistamines: Diphenhydramine, Dimenhydrinate, Doxylamine, Promethazine; Alcohol; Dextromethorphan)
individuals with urinary problems (e.g., BPH)
pregnant or nursing females (as the effect of Scop on fetuses is not known)
suicidality
delusions or hallucinations
history of substance dependence in last five years or substance abuse within the past 6 months

Sites / Locations

University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Scopolamine .4mg

Intranasal placebo

Scopolamine .5mg

Scopolamine .6mg

Arm Description

Participants will be randomized to either .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy

Participants will be randomized to a placebo, administered via nasal drops, prior to each session of exposure therapy

Participants will be randomized to either .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy

Outcomes

Primary Outcome Measures

Eye blink startle reflex

Skin conductance responses and heart rate

Subjective Units of Distress

Secondary Outcome Measures

Self Statements During Public Speaking Scale

Personal Report of Confidence as a Speaker Scale

Subjective units of distress during in vivo speech

Full Information

NCT ID

NCT01900301

First Posted

July 8, 2013

Last Updated

October 3, 2019

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT01900301

Brief Title

Generalization of Extinction Learning

Official Title

Cholinergic Decontextualization of Exposure Therapy for Anxiety

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Fear, whether it occurs in humans suffering from an anxiety disorder or in experimental models with rodents, is reduced by exposing the frightened organism to the fearful stimulus in the absence of any negative consequences (i.e., extinction, or exposure therapy). However, fear often renews when the feared stimulus is encountered in a context different from the exposure context. In rats, the investigators found that interfering with the animal's ability to process contexts during extinction by administering an anticholinergic drug prevented fear renewal. This proposal will determine if the beneficial effect of this drug translates to exposure therapy in socially anxious humans. To this end, 100 individuals with Social Phobia who fear public speaking will undergo repeated sessions of exposure to public speaking, within a virtual reality context. Participants will be randomized to either drug placebo, .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy. One month after completion of exposure therapy, context renewal will be tested by comparing physiological and subjective responses to public speaking in the same virtual context as used during exposure therapy versus a context different than the one used during exposure therapy. The goal is to identify the dose of Scopolamine associated with the greatest reduction in context renewal. In addition, a secondary analysis will attempt to identify those individuals who benefit most from Scopolamine-augmentation of exposure therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Social Anxiety Disorder

Keywords

exposure, scopolamine, extinction learning, social anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Scopolamine .4mg

Arm Type

Experimental

Arm Description

Participants will be randomized to either .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy

Arm Title

Intranasal placebo

Arm Type

Placebo Comparator

Arm Description

Participants will be randomized to a placebo, administered via nasal drops, prior to each session of exposure therapy

Arm Title

Scopolamine .5mg

Arm Type

Experimental

Arm Description

Participants will be randomized to either .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy

Arm Title

Scopolamine .6mg

Arm Type

Experimental

Arm Description

Participants will be randomized to either .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy

Intervention Type

Drug

Intervention Name(s)

Scopolamine

Intervention Description

Participants will be randomized to either, .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy

Intervention Type

Drug

Intervention Name(s)

intranasal placebo

Intervention Description

Participants will be randomized to a drug placebo, administered via nasal drops, prior to each session of exposure therapy

Primary Outcome Measure Information:

Title

Eye blink startle reflex

Time Frame

change from final exposure session to follow-up (8 weeks following baseline)

Title

Skin conductance responses and heart rate

Time Frame

change from final exposure session to follow-up (8 weeks following baseline)

Title

Subjective Units of Distress

Time Frame

change from final exposure session to follow-up (8 weeks following baseline)

Secondary Outcome Measure Information:

Title

Self Statements During Public Speaking Scale

Time Frame

change from baseline to follow-up (8 weeks following baseline)

Title

Personal Report of Confidence as a Speaker Scale

Time Frame

change from baseline to follow-up (8 weeks following baseline)

Title

Subjective units of distress during in vivo speech

Time Frame

change from baseline to follow-up (8 weeks following baseline)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: between the ages of 18 and 55, fluent in English, within normal body weight (BMI=18.5 to 24.9) meet DSM-IV diagnostic criteria for Social Phobia and report a fear of public speaking. Exclusion Criteria: participant report of a diagnosed medical or neurological disorder prescription or over the counter medications that can interact with Scopolamine, such as anticholinergic medications (e.g. belladonna alkaloids, antihistamines, meclizine, tricyclic antidepressants, and muscle relaxants), cold medicines, cough suppressants. Other drugs that will be reasons for exclusion include: antimuscarinics, nifedipine, parasympathomimetics, amantadine, amoxapine, antacids, antidiarrheals, anxiolytics, hypnotics, atomexetine, bupropion, cisapride, clozapine, cyclobenzaprine, digoxin, disopyramide, dronabinol (THC), ethanol, maprotilline, memantine, metoclopramide, nabilone, olanzapine, opiate agonists, orphenadrine, phenothiazines, potassium salts, quinidine, sedating H1-blockers, topiramate, tricyclic antidepressants, erthyromycin, ketoconazole, and tegaserod. over the counter drugs or substances that may have a sedative effect (e.g. herbal sedatives: ashwagandha, Duboisia hopwoodii, Prostanthera striatiflora, kava, mandrake, valerian, cannabis, passiflora incarnate; Antihistamines: Diphenhydramine, Dimenhydrinate, Doxylamine, Promethazine; Alcohol; Dextromethorphan) individuals with urinary problems (e.g., BPH) pregnant or nursing females (as the effect of Scop on fetuses is not known) suicidality delusions or hallucinations history of substance dependence in last five years or substance abuse within the past 6 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michelle G. Craske, Ph.D.

Organizational Affiliation

Department of Psychology, UCLA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael Fanselow, Ph.D.

Organizational Affiliation

Department of Psychology, UCLA

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31174846

Citation

Craske MG, Fanselow M, Treanor M, Bystritksy A. Cholinergic Modulation of Exposure Disrupts Hippocampal Processes and Augments Extinction: Proof-of-Concept Study With Social Anxiety Disorder. Biol Psychiatry. 2019 Nov 1;86(9):703-711. doi: 10.1016/j.biopsych.2019.04.012. Epub 2019 Apr 19.

Results Reference

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Generalization of Extinction Learning

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