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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

280 Participants
are divided into 1 treatment group
Group A: Neuroimaging Investigation GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Depression Severity measured by the Beck Depression Inventory (BDI)

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

Time frame
Up to 3 years
2

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

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

Time frame
Up to 3 years
3

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

Time frame
Up to 3 years

Secondary outcomes

1

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

Scores range from 0-60 with a higher score indicating higher depression severity

Time frame
Up to 3 years
2

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

Scores range from 17-113 with a higher score indicating higher depression severity

Time frame
Up to 3 years
3

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

Scores range from 0-14 with a higher score indicating higher Anhedonia severity

Time frame
Up to 3 years
4

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

Scores range from 0-18 with a higher score indicating more Cannabis Use

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Nathan Kline Institute for Psychiatric Research

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator