Cannabis DependenceMultimodalNCT03104257
The Neural Correlates of Cannabis Use
An observational study of Cannabis Dependence and Healthy, run by Yale University at 1 site in United States.
Trial summary
The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed abstinence. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Dependence, Healthy
- What is being tested?
- [11-C]OMAR
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 27 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Research subjects can be both cannabis-using or non-cannabis using males and females between the ages of 18-65.
Who may be able to join
- Current cannabis consumption
- Willing to abstain from cannabis use for four weeks
- No current cannabis consumption
Who cannot join
- MRI metal exclusions and claustrophobia
- Education completed is less than 12 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Conneticut Mental Health Center
New Haven, Connecticut, 06519
About this study
The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed abstinence. This research will also examine associations between CB1R availability, neural oscillations and cognitive function.
Read the detailed description
The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed outpatient abstinence (confirmed by tracking creatinine adjusted urine THC-COOH levels). This research will also examine associations between CB1R availability, neural oscillations and cognitive function using [11-C]OMAR PET imaging and electroencephalography.
- Conditions
- Cannabis Dependence, Healthy
- Being tested
- [11-C]OMAR
- Keywords
- Healthy Control, Cannabis, Dependence
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11-C]OMARDrug
The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
| Study group | Role | What they receive |
|---|---|---|
| Cannabis Dependent Subjects | Subjects who are frequent cannabis users Receives: Drug: [11-C]OMAR | |
| Healthy Controls | Subjects with no current cannabis use Receives: Drug: [11-C]OMAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
CB1R availability using [11-C]OMAR PET imaging
Change in CB1R availability (e.g. volume distribution).
Measured: Change in CB1R availability from baseline to 48 hours and 28 days
Secondary outcomes (2)
Changes in Cognition during withdrawal using a computerized battery
Changes in cognitive functions such as attention, memory, motor functioning, and processing speed.
Measured: Change in CB1R availability from baseline to 48 hours and 28 days
Changes in brain rhythms measured by Electroencephalography
Changes in electroencephalographic (EEG) brain rhythms related to information processing.
Measured: Change in CB1R availability from baseline to 48 hours and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startDec 2016
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mohini Ranganathan, Yale University
- Investigators
- Mohini Ranganathan, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104257
- Sponsor's protocol ID
- 1308012514
- Other IDs
- 1R01DA040698-01A1
- Acronym
- Multimodal
- Status last verified
- Oct 2025
- First submitted
- 22 Dec 2016
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Correlates of Cannabis Use
- ClinicalTrials.gov ID
- NCT03104257
- Acronym / sponsor ID
- Multimodal / 1308012514
- Conditions
- Cannabis Dependence, Healthy
- Keywords
- Healthy Control, Cannabis, Dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2016
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 7 Apr 2017 (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 purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed abstinence. This research will also examine associations between CB1R availability, neural oscillations and cognitive function.
Detailed description
The purpose of this research study is to determine the temporal course of recovery of CB1R availability and neural oscillations, in cannabis-dependent individuals at baseline, following 48 hour confirmed inpatient abstinence and after four weeks confirmed outpatient abstinence (confirmed by tracking creatinine adjusted urine THC-COOH levels). This research will also examine associations between CB1R availability, neural oscillations and cognitive function using [11-C]OMAR PET imaging and electroencephalography.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis Dependent Subjects | – | Drug: [11-C]OMARSubjects who are frequent cannabis users |
| Healthy Controls | – | Drug: [11-C]OMARSubjects with no current cannabis use |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Research subjects can be both cannabis-using or non-cannabis using males and females between the ages of 18-65.
Key inclusion criteria (3 listed)
- Current cannabis consumption
- Willing to abstain from cannabis use for four weeks
- No current cannabis consumption
Key exclusion criteria (2 listed)
- MRI metal exclusions and claustrophobia
- Education completed is less than 12 years
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 |
|---|---|---|
| [11-C]OMARThe radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan. | Drug | Cannabis Dependent Subjects, Healthy Controls |
Primary outcome
CB1R availability using [11-C]OMAR PET imaging
Time frame: Change in CB1R availability from baseline to 48 hours and 28 days
Change in CB1R availability (e.g. volume distribution).
2 secondary outcomes
Changes in Cognition during withdrawal using a computerized battery
Time frame: Change in CB1R availability from baseline to 48 hours and 28 days
Changes in brain rhythms measured by Electroencephalography
Time frame: Change in CB1R availability from baseline to 48 hours and 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Cannabis Dependence
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
Cannabis Dependence, Harmful Use
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruitingEarly Phase 1
Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream
Cannabis Dependence
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. This study is not recruiting at the moment.
Mohini Ranganathan, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis Dependence and Healthy, run by Yale University at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CB1R availability using [11-C]OMAR PET imaging (time frame: Change in CB1R availability from baseline to 48 hours and 28 days). 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 21 Oct 2025.