Neurobehavioral Correlates of Caffeine on Anxiety, Avoidance and Interoception in Healthy Individuals and Panic Disorder. (BINCAP)

February 25, 2026 updated by: Uppsala University

Adenosine Receptors From Genes to Behavior: Neurobehavioral Correlates of Caffeine on Anxiety, Avoidance, Decision-Making and Interoception in Healthy Individuals and Panic Disorder.

The current study is a placebo-controlled, double-blind, randomized controlled study using a cross-over design, including Healthy Controls (HC) and participants with Panic Disorder (PD).

The primary aim of the study is to investigate the neural correlates and behavioral effects of caffeine (versus placebo), and its impact on emotional reactivity, decision-making, and interoception, and compare the effects in individuals with PD vs HCs. Subjective anxiety and the occurrence of panic attacks will also be measured. Multimodal neuroimaging methods, such as structural and functional MRI, will be used to address the aims of the study.

Emotional reactivity, emotional decision-making and interoception will be measured with experimental tasks in a 7 Tesla (7T) magnetic resonance (MR) scanner, jointly with measures of skin conductance, heart rate, respiratory rate, and self-reported ratings of anxiety and interoception.

Emotional reactivity will be assessed using emotional and neutral faces. Emotional decision-making will be assessed with an approach-avoidance conflict task. Changes in interoception (bodily sensation, such as pulse and respiration) will be explored using a task in which participants are asked to focus on their breathing or an external stimulus. Caffeine effects on brain resting-state activity will also be assessed. All tasks will be conducted while in the 7T MR scanner.

A secondary aim of the study is to examine the impact of genetic variability in the adenosine A2A receptor (ADORA2A) genotype (e.g., rs5751876 T/T) on the effects of caffeine (vs placebo), as ADORA2A genotype has previously been associated with elevated caffeine-induced anxiety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Given the novelty of the intended study and the lack of previous neuroimaging and emotion-related behavioral studies on caffeine effects in HCs and PD, analyses will be exploratory without directed hypotheses.

It is intended to conduct between-group analyses (HCs vs PD) in the two conditions (caffeine versus placebo), as well as within-group analyses in HCs and PD separately. Between-group analyses will also be conducted between individuals with different ADORA2A genotypes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Lund, Sweden
        • National 7T Facility - Lunds universitet
      • Uppsala, Sweden, 75185
        • Uppsala University, Department of Medical Sciences, Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Panic Disorder group (PD): Primary diagnosis of Panic Disorder.
  • Healthy control group (HCs): No current or history of psychiatric disorders.
  • All participants (PD and HCs): Weekly caffeine consumption ≤ 300 mg.

Exclusion Criteria:

  • Weekly caffeine consumption ≥ 300 mg.
  • Thoracic or head surgery, or any other surgery or metallic implanted devices not compatible with the safety standards for 7T MR scanner.
  • History of severe psychiatric disorder (e.g., schizophrenia).
  • Somatic or neurological conditions (e.g., hypertension and heart condition).
  • Ongoing treatment with psychotropic medication or treatment with psychotropic medication which has been discontinued within 2 months.
  • Other ongoing treatments that may confound the results.
  • Current drug or alcohol abuse/dependency.
  • Habitual nicotine use.
  • Uncorrected visual or hearing impairment.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Panic Disorder
Participants will be randomized to start with either the caffeine condition or the placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1).
Drug: Placebo
Placebo capsule, oral intake
Dietary supplement: Caffeine
Caffeine capsule 250 mg, oral intake
Other: Healthy controls
Participants will be randomized to start with either the caffeine condition or the placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1).
Drug: Placebo
Placebo capsule, oral intake
Dietary supplement: Caffeine
Caffeine capsule 250 mg, oral intake

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Task-related BOLD fMRI signal
Time Frame: Session 1 (day 1)
Task-related BOLD (blood-oxygen-level-dependent) fMRI (functional magnetic resonance imaging) signal will be collected through a 7T MR scanner, starting approximately 30 minutes after oral intake of caffeine or placebo pill. Tasks: Emotional reactivity, Approach-Avoidance Conflict Task, Interoception, Resting-state fMRI.
Session 1 (day 1)
Task-related BOLD fMRI signal
Time Frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Task-related BOLD (blood-oxygen-level-dependent) fMRI (functional magnetic resonance imaging) signal will be collected through a 7T MR scanner, starting approximately 30 minutes after oral intake of caffeine or placebo pill. Tasks: Emotional reactivity, Approach-Avoidance Conflict Task, Interoception, Resting-state fMRI.
Session 2 (day 2; minimum of 36 hours after session/day 1)
Self-reported anxiety
Time Frame: Session 1 (day 1)
Anxiety will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task measured with self-reported ratings, on a scale from 0-100 (0= no anxiety - 100= extreme anxiety).
Session 1 (day 1)
Self-reported anxiety
Time Frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Anxiety will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task measured with self-reported ratings, on a scale from 0-100 (0= no anxiety - 100= extreme anxiety).
Session 2 (day 2; minimum of 36 hours after session/day 1)
Self-reported interoceptive awareness
Time Frame: Session 1 (day 1)
Interoceptive awareness will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task in the MR scanner, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no awareness - 100= extreme awareness).
Session 1 (day 1)
Self-reported interoceptive awareness
Time Frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Interoceptive awareness will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task in the MR scanner, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no awareness - 100= extreme awareness).
Session 2 (day 2; minimum of 36 hours after session/day 1)
Self-reported interoceptive functional impairment
Time Frame: Session 1 (day 1)
Interoceptive functional impairment will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no impairment - 100= extreme impairment).
Session 1 (day 1)
Self-reported interoceptive functional impairment
Time Frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Interoceptive functional impairment will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no impairment - 100= extreme impairment).
Session 2 (day 2; minimum of 36 hours after session/day 1)
Skin conductance responses (SCR)
Time Frame: Session 1 (day 1)
Skin conductance responses will be used to assess emotional reactivity at the physiological level to emotional stimuli vs neutral stimuli (faces).
Session 1 (day 1)
Skin conductance responses (SCR)
Time Frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Skin conductance responses will be used to assess emotional reactivity at the physiological level to emotional stimuli vs neutral stimuli (faces).
Session 2 (day 2; minimum of 36 hours after session/day 1)
Occurrence of panic attacks
Time Frame: Session 1 (day 1)
The occurrence of panic attacks will be assessed according to the Diagnostic Statistical Manual (DSM-5) criteria for panic attacks and will be coded dichotomous as "present" or "not present".
Session 1 (day 1)
Occurrence of panic attacks
Time Frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
The occurrence of panic attacks will be assessed according to the Diagnostic Statistical Manual (DSM-5) criteria for panic attacks and will be coded dichotomous as "present" or "not present".
Session 2 (day 2; minimum of 36 hours after session/day 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Structural brain data, T1-w sMRI
Time Frame: Session 1 (day 1)
Structural brain changes will be analyzed through T1-weighted sMRI (structural magnetic resonance imaging).
Session 1 (day 1)
Structural brain data, T1-w sMRI
Time Frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Structural brain changes will be analyzed through T1-weighted sMRI (structural magnetic resonance imaging).
Session 2 (day 2; minimum of 36 hours after session/day 1)
Heart rate variability
Time Frame: Session 1 (day 1)
Heart rate variability (HRV) will be assessed by using a 7T MR-compatible heart rate band, during the whole MR scanner time.
Session 1 (day 1)
Heart rate variability
Time Frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Heart rate variability (HRV) will be assessed by using a 7T MR-compatible heart rate band, during the whole MR scanner time.
Session 2 (day 2; minimum of 36 hours after session/day 1)
Respiratory rate
Time Frame: Session 1 (day 1)
Respiratory or breathing rates will be assessed during the whole MR scanner time.
Session 1 (day 1)
Respiratory rate
Time Frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Respiratory or breathing rates will be assessed during the whole MR scanner time.
Session 2 (day 2; minimum of 36 hours after session/day 1)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Expectancy ratings
Time Frame: Session 1 (day 1)
Participants will be asked to report if they believed they received placebo or caffeine and how certain they are on a scale from 0-100% before capsule intake and after completing the MR-session.
Session 1 (day 1)
Expectancy ratings
Time Frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Participants will be asked to report if they believed they received placebo or caffeine and how certain they are on a scale from 0-100% before capsule intake and after completing the MR-session.
Session 2 (day 2; minimum of 36 hours after session/day 1)
Panic Disorder Severity Scale (PDSS)
Time Frame: 1-7 days prior to session 1 (internet)
PDSS is a self-reported questionnaire that assesses the severity of Panic Disorder; range 0-28, higher scores indicating more severe symptoms.
1-7 days prior to session 1 (internet)
Body Sensations Questionnaire (BSQ)
Time Frame: 1-7 days prior to session 1 (internet)
BSQ assesses body sensations present during aversive situations; range 17-85, higher scores indicating higher levels of body sensations.
1-7 days prior to session 1 (internet)
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
Time Frame: 1-7 days prior to session 1 (internet)
MAIA-2 is an 8-scale state-trait questionnaire with 37 items to measure multiple dimensions of interoception by self- report. The score of each scale is the the average of the items on each scale. Higher mean scores indicate higher levels of the measured dimensions (Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness,Self-Regulation, Body Listening, and Trust) on a scale from 0-5 (0=never- 5=always), respectively.
1-7 days prior to session 1 (internet)
Anxiety Sensitivity Index (ASI)
Time Frame: 1-7 days prior to session 1 (internet)
ASI assesses anxiety sensitivity; range 0-64, higher scores indicating higher anxiety sensitivity.
1-7 days prior to session 1 (internet)
Spielberger State-Trait Anxiety Inventory (STAI-T)
Time Frame: 1-7 days prior to session 1 (internet)
STAI-T is a self-rated questionnaire assessing trait anxiety; range 20-80, higher scores represent higher levels of trait anxiety.
1-7 days prior to session 1 (internet)
Caffeine Expectancy Questionnaire (CaffEQ)
Time Frame: 1-7 days prior to session 1 (internet)
CaffEQ is a self-rated questionnaire that assesses expected effect of caffeine intake.
1-7 days prior to session 1 (internet)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Frick, PhD, Uppsala University, Department of Medical Sciences, Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-02915-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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