Neural and Psychiatric Consequences of Cannabis Use in Adolescents (Cann-Teen)

University of Miami

Status: Enrolling

Conditions: Cannabis Use; Depression

Treatments: Behavioral: Neuroimaging Investigation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06941298

R01DA059527 (U.S. NIH Grant/Contract)

20241204

Details and patient eligibility

About

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

Enrollment: 280 estimated patients

Sex: All

Ages: 14 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

1. 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 criteria

1. MRI contraindications such as claustrophobia, metallic ink tattoos, orthodontic braces, or pacemakers
2. positive pregnancy tests
3. neurological illnesses and medical conditions such as unique pain syndromes (e.g. multiple sclerosis, rheumatoid arthritis)
4. estimated full-scale Intelligence Quotient (IQ) ≤80 to ensure that participants have the ability to understand the study112
5. current Substance Use Disorder (SUD) other than cannabis or nicotine.
6. certified for or self-reported medical cannabis use, or intent to become certified
7. current stimulant use (methamphetamine or cocaine) by self-report or urine toxicology
8. oral contraceptives will be allowed and controlled for in order to maximize recruitment of older adolescents.

Depressed THC non-users:

1. psychotropic medication-free for >1 month (or >3 months for medications with a long half- life such as fluoxetine) prior to study enrollment.
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.
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,

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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280 participants in 1 patient group

Neuroimaging Investigation Group

Experimental group

Description:

Participants in this group will receive neuroimaging investigation for up to 2 years.

Treatment:

Behavioral: Neuroimaging Investigation