Augmented Interoceptive Exposure Training in Anorexia Nervosa

NCT03019081 | Unknown

• 1 other identifier: 2015-013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (2)

• Anxiety

  Visual analogue self report rating scale

  Immediately after drug/placebo infusion

• Sensation intensity

  Heartbeat and breathing sensation intensity via self report rating scale

  Immediately after drug/placebo infusion

Secondary Outcomes (4)

• Anxiety sensitivity index

  Immediately after drug/placebo infusion

• Positive and Negative Affect

  Immediately after drug/placebo infusion

• Inventory of Depression and Anxiety

  Immediately after drug/placebo infusion

• Multidimensional Assessment of Interoceptive Awareness

  Immediately after drug/placebo infusion

Study Arms (2)

Anorexia nervosa-study drug

EXPERIMENTAL

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: Isoproterenol

Anorexia nervosa-placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

Isoproterenol DRUG

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.

Also known as: Isuprel

Anorexia nervosa-study drug

placebo OTHER

placebo

Also known as: Normal Saline

Anorexia nervosa-placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Isoproterenol; Saline Solution

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sahib S Khalsa, MD, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 12, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2021
• Study Completion: November 1, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)