Cannabis DependenceNCT02711371
Social and Emotional Brain Function in Cannabis Users
An observational study of Cannabis Dependence, run by University of Electronic Science and Technology of China at 1 site in Germany.
Trial summary
The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether and how social and emotional brain function are altered in dependent cannabis users relative to healthy non-using control subjects after a 28 supervised abstinence period. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Dependence
- What is being tested?
- fMRI
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Jul 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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Cannabis dependent individuals
Who may be able to join
- Cannabis dependence according to DSM 4 criteria
- 28 days of supervised abstinence
Who cannot join
- other DSM 4 diagnosis
- neurological disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Bonn / Department of Psychiatry
Bonn, North Rhine-Westphalia, 53111
About this study
Official title: Long-term Effects of Cannabis Use on Social and Emotional Brain Processes in Dependent Cannabis Users After a 28 Day Abstinence Period
The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether and how social and emotional brain function are altered in dependent cannabis users relative to healthy non-using control subjects after a 28 supervised abstinence period. Previous research in cannabis users has predominantly focused on cognitive functions. Moreover, studies have implicated that observed deficits in cannabis users may regenerate after a prolonged abstinence period. Findings might provide important information with respect to relapse vulnerability.
- Conditions
- Cannabis Dependence
- Being tested
- fMRI
- Keywords
- addiction, cannabis, fMRI
- Medical subject headings
- Marijuana Abuse, Behavior, Addictive
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 |
|---|---|---|
| Cannabis Dependence | Cannabis dependent individuals according to DSM 4 criteria, aged 18-40 years Receives: Other: fMRI | |
| Healthy | Healthy controls, 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 activation patterns of social-emotional brain processes after 28 day abstinence
Activity patterns in core regions of the emotion processing \& addiction-related brain networks (e.g. striatal regions, insular cortex, prefrontal cortex) will be assessed after 28-days of abstinence. Alterations will be determined by comparison with matched non-drug using controls
Measured: one timepoint = fMRI assessment after 28 day abstinence period
Secondary outcomes (2)
Ratings of subjective experience (pleasantness, rewarding value) will be assessed after 28 days of abstinence
Self-reported ratings of pleasantness \& rewarding value during soft-pleasant touch.
Measured: one timepoint = during fMRI assessment after 28 day abstinence period
Relapse interview assessed with Timeline-Followback Method
Association between fMRI neural correlates and drug use during follow up period as predictor of relapse
Measured: one timepoint = 24 months post-fMRI-session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis DependenceStudies 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
- 43 participants (actual)
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
- NCT02711371
- Sponsor's protocol ID
- ART_Can_01
- Status last verified
- Feb 2017
- First submitted
- 4 Mar 2016
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Zimmermann K, Yao S, Heinz M, Zhou F, Dau W, Banger M, Weber B, Hurlemann R, Becker B. Altered orbitofrontal activity and dorsal striatal connectivity during emotion processing in dependent marijuana users after 28 days of abstinence. Psychopharmacology (Berl). 2018 Mar;235(3):849-859. doi: 10.1007/s00213-017-4803-6. Epub 2017 Dec 2.
PubMed 29197984
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
- Long-term Effects of Cannabis Use on Social and Emotional Brain Processes in Dependent Cannabis Users After a 28 Day Abstinence Period
- ClinicalTrials.gov ID
- NCT02711371
- Acronym / sponsor ID
- ART_Can_01
- Conditions
- Cannabis Dependence
- Keywords
- addiction, cannabis, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Collaborators
- German Research Foundation, University Hospital, Bonn
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Mar 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.
The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether and how social and emotional brain function are altered in dependent cannabis users relative to healthy non-using control subjects after a 28 supervised abstinence period. Previous research in cannabis users has predominantly focused on cognitive functions. Moreover, studies have implicated that observed deficits in cannabis users may regenerate after a prolonged abstinence period. Findings might provide important information with respect to relapse vulnerability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis Dependence | – | Other: fMRICannabis dependent individuals according to DSM 4 criteria, aged 18-40 years |
| Healthy | – | Other: fMRIHealthy controls, socio-demographically matched |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cannabis dependent individuals
Key inclusion criteria (2 listed)
- Cannabis dependence according to DSM 4 criteria
- 28 days of supervised abstinence
Key exclusion criteria (2 listed)
- other DSM 4 diagnosis
- neurological disorders
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 | Cannabis Dependence, Healthy |
Primary outcome
fMRI neural activation patterns of social-emotional brain processes after 28 day abstinence
Time frame: one timepoint = fMRI assessment after 28 day abstinence period
Activity patterns in core regions of the emotion processing \& addiction-related brain networks (e.g. striatal regions, insular cortex, prefrontal cortex) will be assessed after 28-days of abstinence. Alterations will be determined by comparison with matched non-drug using controls
2 secondary outcomes
Ratings of subjective experience (pleasantness, rewarding value) will be assessed after 28 days of abstinence
Time frame: one timepoint = during fMRI assessment after 28 day abstinence period
Relapse interview assessed with Timeline-Followback Method
Time frame: one timepoint = 24 months post-fMRI-session
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.
- Derived from this study: PubMed 29197984Zimmermann K, Yao S, Heinz M, Zhou F, Dau W, Banger M, Weber B, Hurlemann R, Becker B. Altered orbitofrontal activity and dorsal striatal connectivity during emotion processing in dependent marijuana users after 28 days of abstinence. Psychopharmacology (Berl). 2018 Mar;235(3):849-859. doi: 10.1007/s00213-017-4803-6. Epub 2017 Dec 2.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University of Electronic Science and Technology of China at 1 site in Germany.
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.
Where is the study taking place?
The record lists 1 site in Germany. 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?
fMRI neural activation patterns of social-emotional brain processes after 28 day abstinence (time frame: one timepoint = fMRI assessment after 28 day abstinence period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711371, which also lists 1 linked publication.
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.