RECRUITING

Neural and Psychiatric Consequences of Cannabis Use in Adolescents

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

The goal of this study is to investigate the effects of cannabis on brain function among adolescents with depression.

Official Title

Neural and Psychiatric Consequences of Cannabis Use in Adolescents

Quick Facts

Study Start:2025-03-04
Study Completion:2029-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06941298

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 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. MRI contraindications such as claustrophobia, metallic ink tattoos, orthodontic braces, or pacemakers
  2. 2. positive pregnancy tests
  3. 3. neurological illnesses and medical conditions such as unique pain syndromes (e.g. multiple sclerosis, rheumatoid arthritis)
  4. 4. estimated full-scale Intelligence Quotient (IQ) ≤80 to ensure that participants have the ability to understand the study112
  5. 5. current Substance Use Disorder (SUD) other than cannabis or nicotine.
  6. 6. certified for or self-reported medical cannabis use, or intent to become certified
  7. 7. current stimulant use (methamphetamine or cocaine) by self-report or urine toxicology
  8. 8. oral contraceptives will be allowed and controlled for in order to maximize recruitment of older adolescents.
  9. 1. psychotropic medication-free for \>1 month (or \>3 months for medications with a long half- life such as fluoxetine) prior to study enrollment.
  10. 2. Diagnostic and Statistical Manual 5 (DSM-5) diagnoses of bipolar disorder, psychotic disorders, autism spectrum all non-cannabis substance-related disorders will be exclusionary.
  11. 3. Self-injurious acts (e.g. cutting) and suicidal ideations (SI) without a specific as passive SI) are common in adolescent depression and will be allowed. constitutes an imminent risk to self or others (defined as active SI), the withdrawn from the study and emergency procedures will be initiated immediately,

Contacts and Locations

Study Contact

Vilma Gabbay, MD, JD, MS
CONTACT
305-243-5510
vxg595@miami.edu

Principal Investigator

Vilma Gabbay, MD, JD, MS
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami Clinical Research Building
Miami, Florida, 33136
United States
Nathan Kline Institute
Orangeburg, New York, 10962
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Vilma Gabbay, MD, JD, MS, PRINCIPAL_INVESTIGATOR, University of Miami

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 Date2025-03-04
Study Completion Date2029-06-01

Study Record Updates

Study Start Date2025-03-04
Study Completion Date2029-06-01

Terms related to this study

Keywords Provided by Researchers

  • Adolescents
  • Neuroimaging
  • Functional Magnetic Resonance Imaging (fMRI)
  • Reward
  • Reward Flanker Task
  • Reward Predication Error Task
  • Pain

Additional Relevant MeSH Terms

  • Cannabis Use
  • Depression