Augmented Interoceptive Exposure Training in Anorexia Nervosa

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laureate Institute for Brain Research, Inc.
• Collaborator: Brain & Behavior Research Foundation
• Treatments: Isoproterenol

Criteria

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.