Augmented Interoceptive Exposure Training in Anorexia Nervosa
Anorexia Nervosa
About this trial
This is an interventional treatment trial for Anorexia Nervosa
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.
Sites / Locations
- Laureate Institute for Brain Research
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Anorexia nervosa-study drug
Anorexia nervosa-placebo
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