Clinical trial NCT06941298: Neural and Psychiatric Consequences of Cannabis Use in Adolescents
Official title: Neural and Psychiatric Consequences of Cannabis Use in Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis Use
Depression
Keywords: Adolescents
Neuroimaging
Functional Magnetic Resonance Imaging (fMRI)
Reward
Reward Flanker Task
Reward Predication Error Task
Pain
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Nathan Kline Institute for Psychiatric Research
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-04-23
Enrollment: 280
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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,

Primary outcomes:
measure: Depression Severity measured by the Beck Depression Inventory (BDI)
timeFrame: Up to 3 years
measure: Anhedonia Severity measured by the Temporal Experience of Pleasure Scale (TEPS)
timeFrame: Up to 3 years
measure: Cannabis Use measured by the Daily Frequency, Age of Onset, and Quantity of Cannabis Use (DFAQCU) Inventory
timeFrame: Up to 3 years
Secondary outcomes:
measure: Depression Severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: Up to 3 years
measure: Depression Severity measured by the Convergence of Children's Depression Rating Scale-revised (CDRSR)
timeFrame: Up to 3 years
measure: Anhedonia Severity measured by the Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: Up to 3 years
measure: Cannabis Use measured by the Cannabis Use Problems Identification Test (CUPIT)
timeFrame: Up to 3 years
measure: Cannabis Use measured by a quantitative cannabinoid metabolites urine analysis
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Clinical Research Building
state: Florida
city: Orangeburg
country: United States
facility: Nathan Kline Institute
state: New York
Study officials:
affiliation: University of Miami
name: Vilma Gabbay, MD, JD, MS
role: PRINCIPAL_INVESTIGATOR
References: