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Sympathomimetic Agent

Isoproterenol Exposure Training for Anorexia

N/A

Waitlist Available

Led By Sahib S Khalsa, MD, PhD

Research Sponsored by Laureate Institute for Brain Research, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a body mass index between 17 to 35 kg/m²

Be between 18 and 65 years old

Must not have

Non-correctable vision or hearing problems

AN reporting a seizure within the past year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after drug/placebo infusion

Summary

This trial is testing if a drug that causes heart and respiratory sensations can help people with anorexia by reducing anxiety around meal times.

Who is the study for?

This trial is for adults aged 18-40 with Anorexia Nervosa or a high risk of the disorder, as indicated by certain screening scores. Participants must have a BMI between 17 to 35 and be able to understand English well enough to consent and follow study procedures. They should not be on mood stabilizers or antipsychotic medications, nor have severe heart issues, other major health problems, drug/alcohol dependence, or recent medication changes.

What is being tested?

The trial tests whether infusions of Isoproterenol (a drug that affects the heart rate) can help reduce anxiety during meal anticipation in those with anorexia nervosa compared to placebo (saline solution). The goal is to see if this approach makes eating less stressful over time.

What are the potential side effects?

Possible side effects from Isoproterenol may include increased heart rate, anxiety sensations during infusion similar to what one might feel when nervous or scared, and potential risks associated with IV treatments such as discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 17 and 35.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have vision or hearing issues that cannot be corrected.

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I have had a seizure in the last year.

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I am currently prescribed medication for mental health issues.

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I have been diagnosed with a serious mental health condition like schizophrenia, bipolar disorder, or have had thoughts of harming myself.

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I have a history of heart or lung disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after drug/placebo infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after drug/placebo infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after drug/placebo infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Sensation intensity

Secondary study objectives

Anxiety sensitivity index

Inventory of Depression and Anxiety

Multidimensional Assessment of Interoceptive Awareness

+1 more

Side effects data

From 2015 Phase 2 trial • 131 Patients • NCT03032965

Site hematoma

Pericardial Effusion

A V Fistula

100%

80%

60%

40%

20%

Study treatment Arm

Adenosine and Isoproterenol

Isoproterenol

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Anorexia nervosa-study drugExperimental Treatment1 Intervention

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

Group II: Anorexia nervosa-placeboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isoproterenol

2015

Completed Phase 3

~22740

0 / 6Eligibility criteria met