Effects of Reduced Environmental Stimulation on Eating Disorders

Completed · Not applicable

Conditions studied: Anorexia Nervosa

In brief

The study proposed in this protocol aims to document the physiological, subjective, behavioral, and neural effects of reduced environmental stimulation (floating) in patients with current or prior anorexia nervosa The primary aim of this study is to determine the safety of this intervention. Secondary aims including determining whether floating has an impact on symptom reports such as those related to anxiety and eating disorders.

Key facts

Study ID

NCT02801084

Run by

Laureate Institute for Brain Research, Inc.

People needed

21

Starts

2016-04-01

Expected to finish

2017-10-19

Last updated by the study team

2022-04-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current or prior diagnosis of anorexia nervosa (AN)
• All AN participants must be weight-restored prior to their participation, defined as having a Body Mass Index (BMI) > 17.5

You may not qualify if…

• Any of the following DSM-V disorders:
• Schizophrenia Spectrum and Other Psychotic Disorders
• Bipolar and Related Disorders
• Currently being treated for their psychiatric condition as an inpatient.
• Active suicidal ideation with intent or plan (as determined by a psychiatrist or clinical psychologist for all participants who report an IDAS-II suicide score > 10).
• Morbid obesity (BMI > 40) or underweight (BMI < 17.5).
• Orthostatic hypotension (defined as a drop of ≥20 mm Hg in systolic blood pressure or a drop of ≥10 mm Hg in diastolic blood pressure when measured shortly after transitioning from lying down to standing).
• Certain drugs or medications consumed within the past week including any psychoactive drugs (e.g., MDMA, LSD, psilocybin, peyote, phencyclidine, ketamine), magnesium supplements (greater than 150mg) or milk of magnesia. Any antihistamine that causes drowsiness (e.g., Benadryl) or any alcohol consumed within the past 12 hours. Caffeine or nicotine consumed within the past 3 hours. For all other medications, participants must be stably medicated prior to participation (defined as having taken the medication for 6 weeks or longer).
• History of unstable liver or renal insufficiency; glaucoma; diabetes; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance.
• Pregnancy as detected by a urine test.
• Failure to adhere to "Pre-float checklist".
• Non-correctable vision or hearing problems.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.