RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-17

Study Completion:2028-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06297278

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.

Ages Eligible for Study:14 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Locations (Sites)

Tolan Park Medical Building

Detroit, Michigan, 48201

United States

Collaborators and Investigators

Sponsor: Wayne State University

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 Registration Dates

Study Start Date2024-05-17

Study Completion Date2028-04-30

Study Record Updates

Study Start Date2024-05-17

Study Completion Date2028-04-30

Terms related to this study

Keywords Provided by Researchers

anxiety
exercise
fear

Additional Relevant MeSH Terms

Adolescence