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Augmented Interoceptive Exposure Training in Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isoproterenol
placebo
Sponsored by
Laureate Institute for Brain Research, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Must have a body mass index between 17 to 35 kg/m²
  2. Must be able to provide written informed consent and must have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures.
  3. Must be capable of performing all tasks during each session of the experiment.

Inclusion criteria (AN participants, n = 50):

Participants (ages 18 to 40) must meet Diagnostic and Statistical Manual (DSM 5) criteria for Anorexia Nervosa, either current or lifetime, or have an Eating Disorder Screen (SCOFF) score ≥ 2 and a current BMI of 17 or greater. Selected medications are allowed, including selective serotonin reuptake inhibitors and benzodiazepines. Mood stabilizers and antipsychotic medications are excluded.

Exclusion Criteria:

  1. No telephone or limited access to a telephone
  2. Has any of the following DSM 5 disorders:

    1. Schizophrenia Spectrum and Other Psychotic Disorders
    2. Bipolar and Related Disorders
    3. Antisocial Personality Disorder
  3. Active suicidal ideation with intent or plan
  4. Obesity with a body mass index > 35 preventing scanner entry.
  5. Illicit stimulant drugs consumed within the past week including methamphetamine or cocaine, assessed via urine drug screen
  6. Active drug or alcohol dependence, or active binge drinking within the last month
  7. Pregnancy as detected by a urine test
  8. Prescription of a medication outside of the accepted range, as determined by best clinical practices and current research.
  9. Change in the dose or prescription of a medication within the 3 weeks before enrolling in the study that could affect subjective responses, e.g., anxiolytics or antidepressants.
  10. Presence of unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disease; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
  11. Non-correctable vision or hearing problems.
  12. Systolic blood pressure > 160 mmHg
  13. Diastolic blood pressure > 100 mmHg

Additional AN-specific exclusion criteria (AN participants):

  1. Any AN individual reporting a history of cardiac or respiratory disease
  2. AN with 12-lead EKG abnormalities other than bradycardia or occasional premature ventricular complexes (PVCs); those with severe bradycardia, e.g. heart rate less than 40 bpm will be excluded.
  3. AN reporting a seizure within the past year
  4. Active antipsychotic, mood stabilizer, lithium, stimulant, or wellbutrin medication prescription.

Sites / Locations

  • Laureate Institute for Brain Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anorexia nervosa-study drug

Anorexia nervosa-placebo

Arm Description

Drug: Isoproterenol Intravenous infusions of isoproterenol, delivered in a randomized double blinded order, in each participant. The isoproterenol dose will range from 0.1 micrograms to 4.0 micrograms and exposure during each visit will not exceed 25.0 micrograms. Participants will rate the experience of heartbeat and breathing sensations as well as anxiety induced by the infusion. Other Names: Isuprel

Drug: Normal Saline Intravenous infusions of normal saline, delivered in a randomized double blinded order, in each participant. Participants will rate the experience of heartbeat and breathing sensations as well as anxiety induced by the infusion. Other Names: Saline

Outcomes

Primary Outcome Measures

Anxiety
Visual analogue self report rating scale
Sensation intensity
Heartbeat and breathing sensation intensity via self report rating scale

Secondary Outcome Measures

Anxiety sensitivity index
Self report rating scale
Positive and Negative Affect
Self report rating scale
Inventory of Depression and Anxiety
Self report rating scale
Multidimensional Assessment of Interoceptive Awareness
Self report rating scale

Full Information

First Posted
January 9, 2017
Last Updated
October 4, 2023
Sponsor
Laureate Institute for Brain Research, Inc.
Collaborators
Brain & Behavior Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03019081
Brief Title
Augmented Interoceptive Exposure Training in Anorexia Nervosa
Official Title
Augmented Interoceptive Exposure Training for the Fear of Food in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2017 (undefined)
Primary Completion Date
August 2021 (Actual)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laureate Institute for Brain Research, Inc.
Collaborators
Brain & Behavior Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The researchers propose to utilize a pharmacological approach involving infusions of the sympathomimetic agent isoproterenol to repeatedly trigger cardiorespiratory sensations and anxiety during meal anticipation, to facilitate the development of tolerance or a reduction of the anxiety/fear response in individuals with anorexia nervosa. The investigators aim to conduct a proof of principle study to assess for evidence of initial efficacy of this new treatment approach. As a comparator condition, the researchers propose using repeated administration of saline infusions.
Detailed Description
Individuals with anorexia nervosa (AN) are afraid to eat. Moreover, anxiety is a prominent symptom in AN, with anxiety disorders frequently preceding and/or co-occurring with the illness, and with an increased prevalence of anxiety disorders in first-degree family members. Pre-meal anxiety poses a frequent challenge in treatment settings which require adherence to strict meal plans, particularly since it is associated with lower caloric intake. While problematic under current treatment settings, this illness characteristic also provides a potentially important therapeutic target. Unfortunately, straightforward pre-meal treatment with typically effective anxiolytic medicines such as alprazolam are ineffective in individuals with AN, nor do they increase caloric intake. By contrast, cognitive behavioral therapies for anorexia nervosa utilizing exposure therapy, the most effective psychological intervention for anxiety and anxiety disorders, can promote food intake and increase weight in AN. However, such treatments are slow and have less than ideal response rates, suggesting that they could benefit from further optimization. Exposure therapy involves helping patients to voluntarily engage in repeated and sometimes prolonged confrontation with the stimulus that disproportionately provokes the individual's fear. The aim of this practice is to facilitate the development of tolerance or a reduction of the anxiety/fear response that has become conditionally associated with the relevant stimulus, thereby demonstrating to patients that they can learn to manage effectively in the face of anxiety. In the case of anorexia nervosa, the repeated presentation of food and food cues (mental imagery, pictures, smells) elicits distress and facilitates the subsequent development of tolerance of these symptoms. Unfortunately, the effect size of this intervention in AN is relatively small. Here, the researchers investigate whether the use of an acute pharmacological intervention in the context of aversive learning to enhance exposure training can reduce anxiety associated with eating in individuals with anorexia nervosa.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anorexia nervosa-study drug
Arm Type
Experimental
Arm Description
Drug: Isoproterenol Intravenous infusions of isoproterenol, delivered in a randomized double blinded order, in each participant. The isoproterenol dose will range from 0.1 micrograms to 4.0 micrograms and exposure during each visit will not exceed 25.0 micrograms. Participants will rate the experience of heartbeat and breathing sensations as well as anxiety induced by the infusion. Other Names: Isuprel
Arm Title
Anorexia nervosa-placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Normal Saline Intravenous infusions of normal saline, delivered in a randomized double blinded order, in each participant. Participants will rate the experience of heartbeat and breathing sensations as well as anxiety induced by the infusion. Other Names: Saline
Intervention Type
Drug
Intervention Name(s)
Isoproterenol
Other Intervention Name(s)
Isuprel
Intervention Description
The goal of this experiment is to use isoproterenol in the context of inhibitory fear learning to reduce eating-related anxiety in AN, and to explore whether these changes are related to interoceptive awareness and autonomic reactivity.
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Anxiety
Description
Visual analogue self report rating scale
Time Frame
Immediately after drug/placebo infusion
Title
Sensation intensity
Description
Heartbeat and breathing sensation intensity via self report rating scale
Time Frame
Immediately after drug/placebo infusion
Secondary Outcome Measure Information:
Title
Anxiety sensitivity index
Description
Self report rating scale
Time Frame
Immediately after drug/placebo infusion
Title
Positive and Negative Affect
Description
Self report rating scale
Time Frame
Immediately after drug/placebo infusion
Title
Inventory of Depression and Anxiety
Description
Self report rating scale
Time Frame
Immediately after drug/placebo infusion
Title
Multidimensional Assessment of Interoceptive Awareness
Description
Self report rating scale
Time Frame
Immediately after drug/placebo infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have a body mass index between 17 to 35 kg/m² Must be able to provide written informed consent and must have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures. Must be capable of performing all tasks during each session of the experiment. Inclusion criteria (AN participants, n = 50): Participants (ages 18 to 40) must meet Diagnostic and Statistical Manual (DSM 5) criteria for Anorexia Nervosa, either current or lifetime, or have an Eating Disorder Screen (SCOFF) score ≥ 2 and a current BMI of 17 or greater. Selected medications are allowed, including selective serotonin reuptake inhibitors and benzodiazepines. Mood stabilizers and antipsychotic medications are excluded. Exclusion Criteria: No telephone or limited access to a telephone Has any of the following DSM 5 disorders: Schizophrenia Spectrum and Other Psychotic Disorders Bipolar and Related Disorders Antisocial Personality Disorder Active suicidal ideation with intent or plan Obesity with a body mass index > 35 preventing scanner entry. Illicit stimulant drugs consumed within the past week including methamphetamine or cocaine, assessed via urine drug screen Active drug or alcohol dependence, or active binge drinking within the last month Pregnancy as detected by a urine test Prescription of a medication outside of the accepted range, as determined by best clinical practices and current research. Change in the dose or prescription of a medication within the 3 weeks before enrolling in the study that could affect subjective responses, e.g., anxiolytics or antidepressants. Presence of unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disease; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments. Non-correctable vision or hearing problems. Systolic blood pressure > 160 mmHg Diastolic blood pressure > 100 mmHg Additional AN-specific exclusion criteria (AN participants): Any AN individual reporting a history of cardiac or respiratory disease AN with 12-lead EKG abnormalities other than bradycardia or occasional premature ventricular complexes (PVCs); those with severe bradycardia, e.g. heart rate less than 40 bpm will be excluded. AN reporting a seizure within the past year Active antipsychotic, mood stabilizer, lithium, stimulant, or wellbutrin medication prescription.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahib S Khalsa, MD, PhD
Organizational Affiliation
Laureate Institute for Brain Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laureate Institute for Brain Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Augmented Interoceptive Exposure Training in Anorexia Nervosa

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