Neural and Psychiatric Consequences of Cannabis Use in Adolescents

NCT06941298 | Recruiting DMC

• 2 other identifiers: 20241204R01DA059527
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cannabis Use; Depression

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Depression Severity measured by the Beck Depression Inventory (BDI)

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

  Up to 3 years

• Anhedonia Severity measured by the Temporal Experience of Pleasure Scale (TEPS)

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

  Up to 3 years

• Cannabis Use measured by the Daily Frequency, Age of Onset, and Quantity of Cannabis Use (DFAQCU) Inventory

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

  Up to 3 years

Secondary Outcomes (5)

• Depression Severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)

  Up to 3 years

• Depression Severity measured by the Convergence of Children's Depression Rating Scale-revised (CDRSR)

  Up to 3 years

• Anhedonia Severity measured by the Snaith-Hamilton Pleasure Scale (SHAPS)

  Up to 3 years

• Cannabis Use measured by the Cannabis Use Problems Identification Test (CUPIT)

  Up to 3 years

• Cannabis Use measured by a quantitative cannabinoid metabolites urine analysis

  Up to 3 years

Study Arms (1)

Neuroimaging Investigation Group

EXPERIMENTAL

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

Behavioral: Neuroimaging Investigation

Interventions

Neuroimaging Investigation BEHAVIORAL

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.

Neuroimaging Investigation Group

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• All participants:
• 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.
• Depressed THC non-users:
• 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).
• Healthy controls will have no lifetime history of any major psychiatric diagnoses and no use of any THC.

Sponsors & Collaborators

• University of Miami: lead
• Nathan Kline Institute for Psychiatric Research: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Miami Clinical Research Building

Miami, Florida, 33136, United States

RECRUITING

Nathan Kline Institute

Orangeburg, New York, 10962, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Depression; Pain

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vilma Gabbay, MD, JD, MS

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vilma Gabbay, MD, JD, MS

CONTACT

305-243-5510; vxg595@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)