Exercise Facilitation of Adolescent Fear Extinction, Frontolimbic Circuitry, and Endocannabinoids

NCT ID: NCT06297278

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2028-04-30

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Moderate Intensity Exercise

Group Type: EXPERIMENTAL

Moderate Intensity Exercise

Intervention Type: BEHAVIORAL

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.

Control (Coloring)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Moderate Intensity Exercise

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and available for the duration of the study

3. 14-17 years of age upon enrollment

4. Right-handed

5. In good general health as evidenced by medical history

6. Adolescent and parent/guardian are English-speaking, as study assessments are in English

7. Availability of a parent or legal guardian who is willing to provide consent and attend all study visits

Exclusion Criteria

1. Traumatic brain injury with ongoing symptoms

2. Sensory (e.g., hearing) or physical (e.g., motor, balance) impairment or significant developmental delay

3. MRI participants: MRI contraindication (e.g., braces, implants, claustrophobia)

4. Any condition that would contraindicate blood draws (e.g., hemophilia, sickle cell)

5. Past or current diagnosis or presence of likely neurological disorder (e.g., epilepsy), psychotic disorder (e.g., schizophrenia, schizoaffective disorder), or bipolar disorder

6. Severe/unstable medical condition (e.g., diabetes, rheumatoid arthritis)

7. 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

8. Currently pregnant, lactating, or positive pregnancy test at screening visit

9. Current homicidal thoughts or suicide attempt in the past year

10. Current suicidal thoughts requiring immediate intervention

11. Concurrent use (past 6 weeks) of oral contraceptives

12. Diagnosed or probable substance use disorder (past 1-month)

13. Positive drug test at baseline visit (e.g., THC, cocaine)

14. Moderate/severe drug or alcohol use in the past 8 weeks

15. Current or recent (past 1-month) COVID-19 diagnosis or febrile illness

16. Treatment with investigational drug or intervention (past 1-month)

17. Current smoker, vaper, or tobacco or nicotine use (past 1-month)

18. Ongoing exposure to abuse

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Hilary Marusak

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tolan Park Medical Building

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

MacKenna Shampine

Role: primary

mackenna.shampine@wayne.edu

313-242-7464‬

Other Identifiers

R01MH132830

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-23-01-5444

Identifier Type: -

Identifier Source: org_study_id