Neural and Psychiatric Consequences of Cannabis Use in Adolescents

NCT ID: NCT06941298

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2029-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Neuroimaging Investigation Group

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

Group Type: EXPERIMENTAL

Neuroimaging Investigation

Intervention Type: 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.

Interventions

Neuroimaging 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.

Intervention Type: BEHAVIORAL

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,

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nathan Kline Institute for Psychiatric Research

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Vilma Gabbay

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vilma Gabbay, MD, JD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Clinical Research Building

Miami, Florida, United States

Site Status: RECRUITING

Nathan Kline Institute

Orangeburg, New York, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Vilma Gabbay, MD, JD, MS

Role: CONTACT

vxg595@miami.edu

305-243-5510

Facility Contacts

Lilly Mcleod, BS

Role: primary

lxm1750@miami.edu

305-243-1549

Lisle Allen, BS

Role: backup

lxa2171@miami.edu

3052435510

Gaelen Weinberg, BS

Role: primary

gaelen.weinberg@nki.rfmh.org

845-398-5500

Other Identifiers

R01DA059527

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20241204

Identifier Type: -

Identifier Source: org_study_id