Cannabis UseCann-TeenNCT06941298
Neural and Psychiatric Consequences of Cannabis Use in Adolescents
A study testing Neuroimaging Investigation in people with Cannabis Use and Depression, run by University of Miami at 2 sites in United States.
Trial summary
The goal of this study is to investigate the effects of cannabis on brain function among adolescents with depression. Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Depression
- What is being tested?
- Neuroimaging Investigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Mar 2025to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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:
- DSM-5 diagnoses of bipolar disorder, psychotic disorders, autism spectrum disorders, and all non-cannabis substance-related disorders will be exclusionary. However, anxiety disorders, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD) are not uncommon among depressed individuals and will be allowed as long as depressive symptoms are primary. Our focus on behavioral constructs aims to address comorbidity and mechanistic overlap among psychiatric disorders. Were these diagnoses exclusionary, the sample would be highly atypical of depression.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Miami Clinical Research Building
Miami, Florida, 33136
Lilly Mcleod, BS, 305-243-1549, lxm1750@miami.edu
Lisle Allen, BS, 3052435510, lxa2171@miami.edu
- Not yet recruiting
Nathan Kline Institute
Orangeburg, New York, 10962
Gaelen Weinberg, BS, 845-398-5500, gaelen.weinberg@nki.rfmh.org
Russell Tobe, MD
About this study
The goal of this study is to investigate the effects of cannabis on brain function among adolescents with depression.
- Conditions
- Cannabis Use, Depression
- Being tested
- Neuroimaging Investigation
- Keywords
- Adolescents, Neuroimaging, Functional Magnetic Resonance Imaging (fMRI), Reward, Reward Flanker Task, Reward Predication Error Task, Pain
- Medical subject headings
- Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroimaging InvestigationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuroimaging Investigation Group | Experimental | Participants in this group will receive neuroimaging investigation for up to 2 years. Receives: Behavioral: Neuroimaging Investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity measured by the Beck Depression Inventory (BDI)
Scores range from 0-63 with a higher score indicating higher depression severity
Measured: 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
Measured: 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
Measured: Up to 3 years
Secondary outcomes (5)
Depression Severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Scores range from 0-60 with a higher score indicating higher depression severity
Measured: Up to 3 years
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
Measured: Up to 3 years
Anhedonia Severity measured by the Snaith-Hamilton Pleasure Scale (SHAPS)
Scores range from 0-14 with a higher score indicating higher Anhedonia severity
Measured: Up to 3 years
Cannabis Use measured by the Cannabis Use Problems Identification Test (CUPIT)
Scores range from 0-18 with a higher score indicating more Cannabis Use
Measured: Up to 3 years
Cannabis Use measured by a quantitative cannabinoid metabolites urine analysis
will be measured in microgram per liter
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start4 Mar 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Vilma Gabbay, University of Miami
- Investigators
- Vilma Gabbay, MD, JD, MS, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941298
- Sponsor's protocol ID
- 20241204
- Other IDs
- R01DA059527
- Acronym
- Cann-Teen
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Psychiatric Consequences of Cannabis Use in Adolescents
- ClinicalTrials.gov ID
- NCT06941298
- Acronym / sponsor ID
- Cann-Teen / 20241204
- Conditions
- Cannabis Use, Depression
- Keywords
- Adolescents, Neuroimaging, Functional Magnetic Resonance Imaging (fMRI), Reward, Reward Flanker Task, Reward Predication Error Task, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Nathan Kline Institute for Psychiatric Research, National Institute on Drug Abuse (NIDA)
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to investigate the effects of cannabis on brain function among adolescents with depression.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroimaging Investigation Group | Experimental | Behavioral: Neuroimaging InvestigationParticipants in this group will receive neuroimaging investigation for up to 2 years. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroimaging InvestigationParticipants 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. | Behavioural | Neuroimaging Investigation Group |
Primary outcome
Depression Severity measured by the Beck Depression Inventory (BDI)
Time frame: Up to 3 years
Scores range from 0-63 with a higher score indicating higher depression severity
Anhedonia Severity measured by the Temporal Experience of Pleasure Scale (TEPS)
Time frame: Up to 3 years
Scores range from 18-108 with a higher score indicating higher Anhedonia severity
Cannabis Use measured by the Daily Frequency, Age of Onset, and Quantity of Cannabis Use (DFAQCU) Inventory
Time frame: Up to 3 years
Scores range from 1-15 with a higher score indicating more Cannabis Use
5 secondary outcomes
Depression Severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Up to 3 years
Depression Severity measured by the Convergence of Children's Depression Rating Scale-revised (CDRSR)
Time frame: Up to 3 years
Anhedonia Severity measured by the Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Up to 3 years
Cannabis Use measured by the Cannabis Use Problems Identification Test (CUPIT)
Time frame: Up to 3 years
Cannabis Use measured by a quantitative cannabinoid metabolites urine analysis
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vilma Gabbay, MD, JD, MS principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroimaging Investigation in people with Cannabis Use and Depression, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vilma Gabbay, MD, JD, MS (305-243-5510, vxg595@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Severity measured by the Beck Depression Inventory (BDI) (time frame: Up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.