Neural and Psychiatric Consequences of Cannabis Use in Adolescents

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-20
SponsorUniversity of Miami

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Neuroimaging Investigation

Treatment groups

280 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Miami

Lead sponsor

Nathan Kline Institute for Psychiatric Research

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator