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OpenTrials
Completed

NCT Number: NCT01900301

Generalization of Extinction Learning

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.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scopolamine

Drug

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

Intranasal placebo

Drug

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

Primary outcomes

  1. Eye blink startle reflex

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

  2. Skin conductance responses and heart rate

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

  3. Subjective Units of Distress

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

Secondary outcomes

  1. Self Statements During Public Speaking Scale

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

  2. Personal Report of Confidence as a Speaker Scale

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

  3. Subjective units of distress during in vivo speech

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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Cholinergic Decontextualization of Exposure Therapy for Anxiety

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 16, 2013
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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