RecruitingNot ApplicableNCT06941298
Neural and Psychiatric Consequences of Cannabis Use in Adolescents
Sponsor
University of Miami
Enrollment
280 participants
Start Date
Mar 4, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The goal of this study is to investigate the effects of cannabis on brain function among adolescents with depression.
Eligibility
Min Age: 14 YearsMax Age: 20 Years
Inclusion Criteria3
- Cannabis users 1) the study team will require majority of adolescents with cannabis use to have a significant cannabis use (self-reported use on ≥15 of the prior 30 days and positive tetrahydrocannabinol (THC) urine toxicology).
- Depression Positive
- \) participants with subthreshold depression, defined as a raw severity score of ≥30 on the Children's Depression Rating Scale-Revised (CDRS-R, for ages 14-17) and as a raw severity score of ≥12 on the Montgomery Asberg Depression Rating Scale (MADRS, for ages 18-20)
Exclusion Criteria12
- MRI contraindications such as claustrophobia, metallic ink tattoos, orthodontic braces, or pacemakers
- positive pregnancy tests
- neurological illnesses and medical conditions such as unique pain syndromes (e.g. multiple sclerosis, rheumatoid arthritis)
- estimated full-scale Intelligence Quotient (IQ) ≤80 to ensure that participants have the ability to understand the study112
- current Substance Use Disorder (SUD) other than cannabis or nicotine.
- certified for or self-reported medical cannabis use, or intent to become certified
- current stimulant use (methamphetamine or cocaine) by self-report or urine toxicology
- oral contraceptives will be allowed and controlled for in order to maximize recruitment of older adolescents.
- Depressed THC non-users:
- psychotropic medication-free for \>1 month (or \>3 months for medications with a long half- life such as fluoxetine) prior to study enrollment.
- Diagnostic and Statistical Manual 5 (DSM-5) diagnoses of bipolar disorder, psychotic disorders, autism spectrum all non-cannabis substance-related disorders will be exclusionary.
- 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 constitutes an imminent risk to self or others (defined as active SI), the withdrawn from the study and emergency procedures will be initiated immediately,
Interventions
BEHAVIORALNeuroimaging Investigation
Participants will undergo fMRI neuroimaging at two timepoints, at the start of the study and at the 1 year follow up. The fMRI is one hour in duration. During the fMRI, participants will complete two tasks investigating diverse aspects of reward circuitry activity. After this is completed, participants will be followed up for another year clinically.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06941298
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