← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after drug/placebo infusion
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My BMI is between 17 and 35.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety
Sensation intensity
Secondary outcome measures
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
3%
Site hematoma
2%
Pericardial Effusion
2%
A V Fistula
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor
49 Previous Clinical Trials
5,218 Total Patients Enrolled
4 Trials studying Anorexia Nervosa
336 Patients Enrolled for Anorexia Nervosa
Brain & Behavior Research FoundationOTHER
61 Previous Clinical Trials
2,788 Total Patients Enrolled
Sahib S Khalsa, MD, PhDPrincipal InvestigatorLaureate Institute for Brain Research
2 Previous Clinical Trials
118 Total Patients Enrolled
2 Trials studying Anorexia Nervosa
118 Patients Enrolled for Anorexia Nervosa

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I qualify to join this experimental research?

"This clinical trial seeks 25 individuals between 18 to 40 years old with a history of anorexia nervosa. Applicants must meet the DSM 5 criteria for Anorexia Nervosa or have an Eating disorder Screen (SCOFF) score ≥ 2 and a body mass index ranging from 17 to 35 kg/m². Selective serotonin reuptake inhibitors and benzodiazepines are accepted, whereas mood stabilizers and antipsychotic medications are not permitted."

Answered by AI

Is this research study open to individuals over the age of 20?

"This medical experiment has eligibility criteria requiring participants to be aged between 18 and 40 years old."

Answered by AI

To what purpose is Isoproterenol typically deployed?

"Isoproterenol can be administered to treat Brugada Syndrome (BRS), pacemaker-reliance, and Beta Blocker overdose."

Answered by AI

How many participants have been recruited for this medical experiment?

"Unfortunately, this specific trial is not in the process of recruiting patients. While it was initially posted on 1/1/2017 and last updated on 4/9/2022, 77 trials for anorexia nervosa and 3 studies related to Isoproterenol are presently enrolling participants."

Answered by AI

Is enrollment still open for this medical experiment?

"Data hosted on clinicaltrials.gov suggests that this research is no longer inviting patients to participate. The trial was first posted in January 2017 and its last update occurred on April 9th 2022, but 80 other trials are presently recruiting individuals for their studies."

Answered by AI

What aim does this experiment seek to accomplish?

"This trial's primary measure of success is the intensity of sensation reported by participants immediately after drug or placebo infusion. Other metrics, such as Multidimensional Assessment of Interoceptive Awareness (a self-report rating scale), Inventory of Depression and Anxiety (another self-report rating scale), and Anxiety Sensitivity Index (yet another self-report rating scale) are also being tracked."

Answered by AI

Have any other investigations been conducted involving Isoproterenol?

"Currently, 3 trials are underway to investigate the efficacy of Isoproterenol with none having reached Phase 3. Of these studies, 4 different trial sites exist in Tulsa, Oklahoma."

Answered by AI
~3 spots leftby Mar 2025