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Generalization of Extinction Learning

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ClinicalTrials.gov Identifier: NCT01900301
Recruitment Status : Recruiting
First Posted : July 16, 2013
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Michelle Craske, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Drug: Scopolamine Drug: intranasal placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cholinergic Decontextualization of Exposure Therapy for Anxiety
Study Start Date : August 2013
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Scopolamine .4mg
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
Drug: Scopolamine
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

Placebo Comparator: Intranasal placebo
Participants will be randomized to a placebo, administered via nasal drops, prior to each session of exposure therapy
Drug: intranasal placebo
Participants will be randomized to a drug placebo, administered via nasal drops, prior to each session of exposure therapy

Experimental: Scopolamine .5mg
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
Drug: Scopolamine
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

Experimental: Scopolamine .6mg
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
Drug: Scopolamine
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




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. participant report of a diagnosed medical or neurological disorder
  2. 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.
  3. 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)
  4. individuals with urinary problems (e.g., BPH)
  5. pregnant or nursing females (as the effect of Scop on fetuses is not known)
  6. suicidality
  7. delusions or hallucinations
  8. history of substance dependence in last five years or substance abuse within the past 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900301


Contacts
Contact: Michael Treanor, Ph.D. 310-825-5614 mtreanor@psych.ucla.edu

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Michelle G. Craske, Ph.D         
Principal Investigator: Michael Fanselow, Ph.D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Michelle G. Craske, Ph.D. Department of Psychology, UCLA
Principal Investigator: Michael Fanselow, Ph.D. Department of Psychology, UCLA

Responsible Party: Michelle Craske, Professor, Department of Psychology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01900301     History of Changes
Other Study ID Numbers: MH101359-01
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

Keywords provided by Michelle Craske, University of California, Los Angeles:
exposure
scopolamine
extinction learning
social anxiety

Additional relevant MeSH terms:
Phobia, Social
Phobic Disorders
Anxiety Disorders
Mental Disorders
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics