Purpose

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

Conditions

Eligibility

Eligible Ages
Between 14 Years and 20 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 constitutes an imminent risk to self or others (defined as active SI), the withdrawn from the study and emergency procedures will be initiated immediately,

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Neuroimaging Investigation Group
Participants in this group will receive neuroimaging investigation for up to 2 years.
  • Behavioral: 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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Miami

Study Contact

Vilma Gabbay, MD, JD, MS
305-243-5510
vxg595@miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.