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Adolescent Cannabis Use, Depression, and Brain Function Study

This study is looking at how cannabis use affects brain function in adolescents (teens) who also have depression. Researchers will use a special type of brain scan called fMRI (functional Magnetic Resonance Imaging) to see how your brain works. They want to understand if cannabis use changes brain activity related to reward. The study is open to teens aged 14 to 20, of all genders, who use cannabis and have depression. To be in the study, you don't need to have a formal diagnosis of cannabis use disorder, but you should use cannabis at least 10 days out of the last 30. Success for this study will be measured by changes in depression severity, how much pleasure you experience (anhedonia), and your cannabis use habits over up to three years. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 280 participants. It is not specified if it is randomized or blinded.
What's involved
You would have two fMRI brain scans, one at the start and one year later, each lasting one hour. You would also complete tasks during the fMRI.
Compensation
Not stated in the trial record.
Follow-up
Your depression severity, anhedonia severity, and cannabis use will be measured for up to three years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06941298

Neural and Psychiatric Consequences of Cannabis Use in Adolescents

Recruiting
NAAges 14–20InterventionalBasic science
University of Miami
~280 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Neuroimaging Investigation

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Depression Severity measured by the Beck Depression Inventory (BDI)
Measured over Up to 3 years
+2 more outcomes measured

Conditions

Cannabis Use
Depression

Explore related trials

Cannabis misuseDepression

NCT06941298

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Nathan Kline Institute

    Orangeburg, New Yorkstudy coordinator listed

    Not yet recruiting

  • University of Miami Clinical Research Building

    Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Vilma Gabbay, MD, JD, MS
[email protected]
305-243-5510
Email the study team

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Eligibility criteria

Inclusion

Cannabis users: To capture a wide range of cannabis use frequency, meeting DSM-5 criteria for cannabis use disorder will not be required. However, in order to ensure sufficient exposure, we will require majority of adolescents with cannabis use to have a significant cannabis use (self-reported use on more or equal to 10 of the prior 30 days and positive THC urine toxicology).
Depression: Similarly, to capture a wide range of depression illness severity, we will allow 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). However, we plan for at least 50% of participants with depressive symptoms to have a raw severity score of \>=40 on the CDRS-R and of \>=20 MADRS, which are considered reliable for depression. Additionally, we will allow participants with a research diagnosis of Major Depressive Disorder as defined by the MINI, even with a CDRS-R score below 30 or a MADRS score below 12. Moreover, because there could be individuals without MDD who have current depressive symptoms, individuals who lack a diagnosis of a depressive disorder but have a CDRS-R score of 30 (or higher) or a MADRS score of 12 (or higher) will be allowed. Through careful recruitment, we will ensure distributions of depression severity. Based on our prior studies employing similar criteria, we anticipate that anhedonia, anxiety and depression severity scores will be normally distributed in our samples.

Exclusion

Psychotropic medication free for more than 1 month (or more than three months for medications with a long half-life such as fluoxetine) prior to study enrollment. We have successfully enrolled hundreds of psychotropic medication-free depressed adolescents and young adults to date. Psychotherapy will be allowed.
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 IQ \<=80 to ensure that participants have the ability to understand the study
Current SUD other than cannabis or nicotine. Excluding nicotine use will limit generalization of our findings and impact feasibility. Similarly, alcohol use will be allowed as long as it is not hazardous and does not meet criteria of a DSM-5 disorder (AUDIT-C \>5). Therefore, nicotine and alcohol use will be allowed and controlled for. Alcohol and cannabis use (assessed based on breathalyzer from alcohol and self-report for cannabis/THC) on the day of the scan will result in rescheduling the scan as it can affect MRI data.
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. Adderall and Vyvanse for ADHD will be allowed as long as use is temporarily paused medication usage at least 3 days before neuroimaging visit. If medication is not discontinued on scan day, scanning at that time will be up to PI discretion.
Oral contraceptives will be allowed and controlled for in order to maximize recruitment of older adolescents.
DSM-5 diagnoses of bipolar disorder, psychotic disorders, autism spectrum disorders, and all non-cannabis substance-related disorders will be exclusionary. However, anxiety disorders, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD) are not uncommon among depressed individuals and will be allowed as long as depressive symptoms are primary. Our focus on behavioral constructs aims to address comorbidity and mechanistic overlap among psychiatric disorders. Were these diagnoses exclusionary, the sample would be highly atypical of depression.
Self-injurious acts (e.g. cutting) and suicidal ideations (SI) without a specific plan (defined as passive SI) are common in adolescent depression and will be allowed. However, if SI constitutes an imminent risk to self or others (defined as active SI), the adolescent will be withdrawn from the study and emergency procedures will be initiated immediately, including ER admission (see Protection of Human Subjects).

What this trial measures

  • Depression Severity measured by the Beck Depression Inventory (BDI)Up to 3 years

    Scores range from 0-63 with a higher score indicating higher depression severity

  • Anhedonia Severity measured by the Temporal Experience of Pleasure Scale (TEPS)Up to 3 years

    Scores range from 18-108 with a higher score indicating higher Anhedonia severity

  • Cannabis Use measured by the Daily Frequency, Age of Onset, and Quantity of Cannabis Use (DFAQCU) InventoryUp to 3 years

    Scores range from 1-15 with a higher score indicating more Cannabis Use