Anorexia NervosaNCT03019081
Augmented Interoceptive Exposure Training in Anorexia Nervosa
A study testing Isoproterenol in people with Anorexia Nervosa, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Isoproterenol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
Official title: Augmented Interoceptive Exposure Training for the Fear of Food in Anorexia Nervosa
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.
Read the detailed description
Individuals with anorexia nervosa (AN) are afraid to eat. Moreover, anxiety is a prominent symptom in AN, with anxiety disorders frequently preceding and/or co-occurring with the illness, and with an increased prevalence of anxiety disorders in first-degree family members. Pre-meal anxiety poses a frequent challenge in treatment settings which require adherence to strict meal plans, particularly since it is associated with lower caloric intake. While problematic under current treatment settings, this illness characteristic also provides a potentially important therapeutic target. Unfortunately, straightforward pre-meal treatment with typically effective anxiolytic medicines such as alprazolam are ineffective in individuals with AN, nor do they increase caloric intake. By contrast, cognitive behavioral therapies for anorexia nervosa utilizing exposure therapy, the most effective psychological intervention for anxiety and anxiety disorders, can promote food intake and increase weight in AN. However, such treatments are slow and have less than ideal response rates, suggesting that they could benefit from further optimization. Exposure therapy involves helping patients to voluntarily engage in repeated and sometimes prolonged confrontation with the stimulus that disproportionately provokes the individual's fear. The aim of this practice is to facilitate the development of tolerance or a reduction of the anxiety/fear response that has become conditionally associated with the relevant stimulus, thereby demonstrating to patients that they can learn to manage effectively in the face of anxiety. In the case of anorexia nervosa, the repeated presentation of food and food cues (mental imagery, pictures, smells) elicits distress and facilitates the subsequent development of tolerance of these symptoms. Unfortunately, the effect size of this intervention in AN is relatively small. Here, the researchers investigate whether the use of an acute pharmacological intervention in the context of aversive learning to enhance exposure training can reduce anxiety associated with eating in individuals with anorexia nervosa.
- Conditions
- Anorexia Nervosa
- Being tested
- Isoproterenol, placebo
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoproterenolDrug
Also called Isuprel
The goal of this experiment is to use isoproterenol in the context of inhibitory fear learning to reduce eating-related anxiety in AN, and to explore whether these changes are related to interoceptive awareness and autonomic reactivity.
placeboOther
Also called Normal Saline
placebo
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa-study drug | Experimental | 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 Receives: Drug: Isoproterenol |
| Anorexia nervosa-placebo | Placebo comparator | 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 Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Visual analogue self report rating scale
Measured: Immediately after drug/placebo infusion
Sensation intensity
Heartbeat and breathing sensation intensity via self report rating scale
Measured: Immediately after drug/placebo infusion
Secondary outcomes (4)
Anxiety sensitivity index
Self report rating scale
Measured: Immediately after drug/placebo infusion
Positive and Negative Affect
Self report rating scale
Measured: Immediately after drug/placebo infusion
Inventory of Depression and Anxiety
Self report rating scale
Measured: Immediately after drug/placebo infusion
Multidimensional Assessment of Interoceptive Awareness
Self report rating scale
Measured: Immediately after drug/placebo infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionAug 2021
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Sponsor
- Investigators
- Sahib S Khalsa, MD, PhD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019081
- Sponsor's protocol ID
- 2015-013
- Status last verified
- Oct 2023
- First submitted
- 9 Jan 2017
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Interoceptive Exposure Training for the Fear of Food in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03019081
- Acronym / sponsor ID
- 2015-013
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- Jan 2017
- Primary completion
- Aug 2021 (actual)
- Study completion
- Nov 2024 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with anorexia nervosa (AN) are afraid to eat. Moreover, anxiety is a prominent symptom in AN, with anxiety disorders frequently preceding and/or co-occurring with the illness, and with an increased prevalence of anxiety disorders in first-degree family members. Pre-meal anxiety poses a frequent challenge in treatment settings which require adherence to strict meal plans, particularly since it is associated with lower caloric intake. While problematic under current treatment settings, this illness characteristic also provides a potentially important therapeutic target. Unfortunately, straightforward pre-meal treatment with typically effective anxiolytic medicines such as alprazolam are ineffective in individuals with AN, nor do they increase caloric intake. By contrast, cognitive behavioral therapies for anorexia nervosa utilizing exposure therapy, the most effective psychological intervention for anxiety and anxiety disorders, can promote food intake and increase weight in AN. However, such treatments are slow and have less than ideal response rates, suggesting that they could benefit from further optimization. Exposure therapy involves helping patients to voluntarily engage in repeated and sometimes prolonged confrontation with the stimulus that disproportionately provokes the individual's fear. The aim of this practice is to facilitate the development of tolerance or a reduction of the anxiety/fear response that has become conditionally associated with the relevant stimulus, thereby demonstrating to patients that they can learn to manage effectively in the face of anxiety. In the case of anorexia nervosa, the repeated presentation of food and food cues (mental imagery, pictures, smells) elicits distress and facilitates the subsequent development of tolerance of these symptoms. Unfortunately, the effect size of this intervention in AN is relatively small. Here, the researchers investigate whether the use of an acute pharmacological intervention in the context of aversive learning to enhance exposure training can reduce anxiety associated with eating in individuals with anorexia nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa-study drug | Experimental | Drug: IsoproterenolDrug: 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 |
| Anorexia nervosa-placebo | Placebo comparator | Other: placeboDrug: 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (21 listed)
- No telephone or limited access to a telephone
- Has any of the following DSM 5 disorders:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsoproterenolAlso: IsuprelThe goal of this experiment is to use isoproterenol in the context of inhibitory fear learning to reduce eating-related anxiety in AN, and to explore whether these changes are related to interoceptive awareness and autonomic reactivity. | Drug | Anorexia nervosa-study drug |
| placeboAlso: Normal Salineplacebo | Other | Anorexia nervosa-placebo |
Primary outcome
Anxiety
Time frame: Immediately after drug/placebo infusion
Visual analogue self report rating scale
Sensation intensity
Time frame: Immediately after drug/placebo infusion
Heartbeat and breathing sensation intensity via self report rating scale
4 secondary outcomes
Anxiety sensitivity index
Time frame: Immediately after drug/placebo infusion
Positive and Negative Affect
Time frame: Immediately after drug/placebo infusion
Inventory of Depression and Anxiety
Time frame: Immediately after drug/placebo infusion
Multidimensional Assessment of Interoceptive Awareness
Time frame: Immediately after drug/placebo infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahib S Khalsa, MD, PhD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoproterenol in people with Anorexia Nervosa, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Immediately after drug/placebo infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.