AdolescenceBRAINSNCT06297278
Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids
A study testing Moderate Intensity Exercise in people with Adolescence, run by Wayne State University at 1 site in United States.
Trial summary
Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these… Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescence
- What is being tested?
- Moderate Intensity Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2024to 30 Apr 2028
- Phase
- Interventional
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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and available for the duration of the study
- 14-17 years of age upon enrollment
- Right-handed
- In good general health as evidenced by medical history
- Adolescent and parent/guardian are English-speaking, as study assessments are in English
- Availability of a parent or legal guardian who is willing to provide consent and attend all study visits
Who cannot join
- Traumatic brain injury with ongoing symptoms
- Sensory (e.g., hearing) or physical (e.g., motor, balance) impairment or significant developmental delay
- MRI participants: MRI contraindication (e.g., braces, implants, claustrophobia)
- Any condition that would contraindicate blood draws (e.g., hemophilia, sickle cell)
- Past or current diagnosis or presence of likely neurological disorder (e.g., epilepsy), psychotic disorder (e.g., schizophrenia, schizoaffective disorder), or bipolar disorder
- Severe/unstable medical condition (e.g., diabetes, rheumatoid arthritis)
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- Current (past 1-month) use of cannabis or cannabinoid products including CBD unless willing to stop for at least 4 weeks prior to entering the study
- Currently pregnant, lactating, or positive pregnancy test at screening visit
- Current homicidal thoughts or suicide attempt in the past year
- Current suicidal thoughts requiring immediate intervention
- Concurrent use (past 6 weeks) of oral contraceptives
- Diagnosed or probable substance use disorder (past 1-month)
- Positive drug test at baseline visit (e.g., THC, cocaine)
- Moderate/severe drug or alcohol use in the past 8 weeks
- Current or recent (past 1-month) COVID-19 diagnosis or febrile illness
- Treatment with investigational drug or intervention (past 1-month)
- Current smoker, vaper, or tobacco or nicotine use (past 1-month)
- Ongoing exposure to abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tolan Park Medical Building
Detroit, Michigan, 48201
MacKenna Shampine, 313-242-7464, mackenna.shampine@wayne.edu
About this study
Anxiety disorders commonly begin during adolescence, and are characterized by deficits in the ability to inhibit or extinguish pathological fear. Recent research has provided new understanding of how fear is learned and can be regulated in the adolescent brain, and how the endocannabinoid system shapes these processes; however, these advances have not yet translated into improved therapeutic outcomes for adolescents with anxiety. This study will test whether a behavioral intervention, acute exercise, can help to improve fear regulation by enhancing brain activity and endocannabinoid signaling. This line of research may ultimately lead to more effect treatments for adolescent anxiety, and to new preventive strategies for at-risk youth.
- Conditions
- Adolescence
- Being tested
- Moderate Intensity Exercise
- Keywords
- anxiety, exercise, fear
- Medical subject headings
- Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity ExerciseBehavioural
Participants randomized to the active (moderate intensity) exercise condition will complete a 3-minute warm-up at low speed on a treadmill. Speed and incline will be increased in 3-minute increments until moderate-intensity exercise, defined as participants staying within a zone of 60-80% AAMHR with the target being to attain and maintain 70-75% AAMHR while briskly walking and/or jogging depending on current fitness status, is reached for a total of 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Exercise | Experimental | Not described Receives: Behavioral: Moderate Intensity Exercise |
| Control (Coloring) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Conductance Responding (SCR)
To compare the effects of acute moderate-intensity exercise (vs. sedentary control) on extinction recall, the investigators will place three electrodes on participant's left hand to acquire SCR data using a BIOPAC MP160 Data Acquisition System (BIOPAC Systems, Inc.).
Measured: Throughout study completion (3 days)
Unconditioned Stimulus (US) Expectancy Ratings
US Expectancy Ratings will be measured during fear learning, extinction, and recall tasks
Measured: Throughout study completion (3 days)
Fear extinction neural circuitry: Functional activation and coupling
MRI eligible only: fMRI blood-oxygen-level-dependent (BOLD) response will be measured across the entire brain during a test of extinction recall. The investigators will focus on response in the hippocampus and ventromedial prefrontal cortex activation and coupling (gPPI) during recall (CS+E>CS+U).
Measured: Neuroimaging will occur during the fear extinction recall phase on Day 3
Endocannabinoid (eCB) Concentrations
Plasma and saliva samples will be collected immediately before and after exercise or sedentary control condition. Samples will be analyzed using liquid chromatography-mass spectrometry to quantify concentrations of eCBs.
Measured: eCB concentrations will be measured in plasma and saliva immediately before and after the exercise or control condition on Day 2
Secondary outcomes (3)
Fear Ratings
Fear ratings to each CS will be captured at the beginning, middle, and end of each phase, using a response pad and a 1-5 visual analog scale (1 = not scary at all, 5 = very scary).
Measured: Throughout study completion (3 days)
Approach/Avoidance Behavior
The investigators will quantify forward-to-backward response pad distance in virtual meters from the conditioned stimulus.
Measured: Throughout study completion (3 days)
Amygdala response during extinction recall
MRI Eligible Only: fMRI blood-oxygen-level-dependent (BOLD) response will be measured across the entire brain during a test of extinction recall. A secondary region of interest is amygdala response during recall (CS+E>CS+U).
Measured: Neuroimaging will occur during the fear extinction recall phase on Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start17 May 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescenceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Hilary Marusak, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297278
- Sponsor's protocol ID
- IRB-23-01-5444
- Other IDs
- R01MH132830
- Acronym
- BRAINS
- Status last verified
- Oct 2026
- First submitted
- 15 Feb 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No