Augmented Interoceptive Exposure Training in Anorexia Nervosa

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Anorexia Nervosa

In brief

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.

Key facts

Study ID

NCT03019081

Run by

Laureate Institute for Brain Research, Inc.

People needed

25

Starts

2017-01-01

Expected to finish

2024-11-01

Last updated by the study team

2023-10-05

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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
• 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.

Where it is running

• Laureate Institute for Brain Research — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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