Recreational Cannabis UseNCT02801214
Emotional Brain Processes in Recreational Cannabis Users
An observational study of Recreational Cannabis Use, run by University of Electronic Science and Technology of China.
Trial summary
This fMRI study investigates neural correlates of emotion regulation, emotion processing and craving in recreational cannabis users. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Recreational Cannabis Use
- What is being tested?
- fMRI
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Recreational male cannabis users
Who may be able to join
- Recreational cannabis use
- 72 hours of abstinence
Who cannot join
- neurological disorders
- psychiatric disorders according to DSM-4
About this study
Official title: Effects of Recreational Cannabis Use on Brain Activation Patterns Associated With Emotional Processes
This fMRI study investigates neural correlates of emotion regulation, emotion processing and craving in recreational cannabis users.
- Conditions
- Recreational Cannabis Use
- Being tested
- fMRI
- Keywords
- cannabis, fMRI, emotion
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
| Study group | Role | What they receive |
|---|---|---|
| Recreational Cannabis Use | ages 18-40 Receives: Other: fMRI | |
| Healthy control subjects | socio-demographically matched Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI neural correlates of emotional brain processes in recreational cannabis users after 72 hours of abstinence
Activation patterns in brain regions known to be involved in emotional processing and to be altered by cannabis use (e.g. striatum, prefrontal cortex, insula, ACC)
Measured: one time point = fMRI assessment after 72 hours of abstinence
Secondary outcomes (1)
Ratings of subjective experience (affect, craving)
Measured: one time point = during fMRI assessment after 72 hours of abstinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recreational Cannabis UseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, University Hospital, Bonn
- Responsible party
- Principal investigator, Benjamin Becker, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801214
- Sponsor's protocol ID
- ART_Can_02
- Status last verified
- Feb 2017
- First submitted
- 11 Jun 2016
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Recreational Cannabis Use on Brain Activation Patterns Associated With Emotional Processes
- ClinicalTrials.gov ID
- NCT02801214
- Acronym / sponsor ID
- ART_Can_02
- Conditions
- Recreational Cannabis Use
- Keywords
- cannabis, fMRI, emotion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Collaborators
- German Research Foundation, University Hospital, Bonn
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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.
This fMRI study investigates neural correlates of emotion regulation, emotion processing and craving in recreational cannabis users.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recreational Cannabis Use | – | Other: fMRIages 18-40 |
| Healthy control subjects | – | Other: fMRIsocio-demographically matched |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recreational male cannabis users
Key inclusion criteria (2 listed)
- Recreational cannabis use
- 72 hours of abstinence
Key exclusion criteria (2 listed)
- neurological disorders
- psychiatric disorders according to DSM-4
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 |
|---|---|---|
| fMRI | Other | Healthy control subjects, Recreational Cannabis Use |
Primary outcome
fMRI neural correlates of emotional brain processes in recreational cannabis users after 72 hours of abstinence
Time frame: one time point = fMRI assessment after 72 hours of abstinence
Activation patterns in brain regions known to be involved in emotional processing and to be altered by cannabis use (e.g. striatum, prefrontal cortex, insula, ACC)
1 secondary outcome
Ratings of subjective experience (affect, craving)
Time frame: one time point = during fMRI assessment after 72 hours of abstinence
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 2 Feb 2017.
Related trials for Recreational Cannabis Use
Active, not recruiting
Regulated Cannabis Access in Basel
Cannabis Use Disorder, Mental Health Disorder
Recruiting
Transcranial Magnetic Brain Stimulation to Reduce Cannabis Use in Heavy Cannabis Users
Cannabis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Recreational Cannabis Use, run by University of Electronic Science and Technology of China.
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 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
fMRI neural correlates of emotional brain processes in recreational cannabis users after 72 hours of abstinence (time frame: one time point = fMRI assessment after 72 hours of abstinence). 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 2 Feb 2017.