Cannabis DependenceNCT02801422
Neural Indices Associated With Relapse in Cannabis Dependence
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 fMRI study is to investigate neural indices of relapse in cannabis dependence. The development and maintenance of drug addictions have been associated with deficits in cognitive control, craving and impaired stress regulation. 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
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Mar 2019
- 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
- 24 hours abstinence
Who cannot join
- other DSM-4 diagnosis
- neurological disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Bonn
Bonn, North Rhine Westfalia, 53127
Benjamin Becker, PhD, +4917620090499, ben_becker@gmx.de
Kaeli Zimmermann, MSc, +4922828719704, kaeli.zimmermann@gmx.de
About this study
Official title: Altered Neural Activation Patterns of Emotional Processing in Dependent Cannabis Users Associated With Relapse
The aim of this fMRI study is to investigate neural indices of relapse in cannabis dependence. The development and maintenance of drug addictions have been associated with deficits in cognitive control, craving and impaired stress regulation. Therefore, neural markers of brain processes underlying the beforementioned components will be studied. Subsequent follow-up drug use interviews will reveal associations between relapse in cannabis dependence and alterations in brain networks of cognitive control, craving and stress.
- Conditions
- Cannabis Dependence
- Being tested
- fMRI
- Keywords
- cannabis, fMRI, addiction, relapse
- Medical subject headings
- Marijuana Abuse, Behavior, Addictive, Recurrence
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 | 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 activation patterns of emotional processing
Activation patterns associated with emotion processing, emotion regulation, craving and stress are determined in addicted cannabis users compared to non-using matched control subjects
Measured: one time point = fMRI assessment after minimum 24 hours of abstinence
Secondary outcomes (1)
Timeline Followback Interviews
Association between fMRI correlates and drug use during follow up preiod as predictor for relapse
Measured: one time point = 12 months after fMRI data acquisition
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 startFeb 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
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.
- 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
- Prospective
- Enrolment
- 75 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
- NCT02801422
- Sponsor's protocol ID
- ART_Can_03
- Status last verified
- Oct 2018
- First submitted
- 11 Jun 2016
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Neural Activation Patterns of Emotional Processing in Dependent Cannabis Users Associated With Relapse
- ClinicalTrials.gov ID
- NCT02801422
- Acronym / sponsor ID
- ART_Can_03
- Conditions
- Cannabis Dependence
- Keywords
- cannabis, fMRI, addiction, relapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Collaborators
- German Research Foundation, University Hospital, Bonn
- Study start
- Feb 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- 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.
The aim of this fMRI study is to investigate neural indices of relapse in cannabis dependence. The development and maintenance of drug addictions have been associated with deficits in cognitive control, craving and impaired stress regulation. Therefore, neural markers of brain processes underlying the beforementioned components will be studied. Subsequent follow-up drug use interviews will reveal associations between relapse in cannabis dependence and alterations in brain networks of cognitive control, craving and stress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis Dependence | – | Other: fMRIages 18-40 |
| Healthy control subjects | – | Other: fMRIsocio-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
- 24 hours abstinence
Key exclusion criteria (2 listed)
- other DSM-4 diagnosis
- neurological disorder
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 control subjects |
Primary outcome
fMRI neural activation patterns of emotional processing
Time frame: one time point = fMRI assessment after minimum 24 hours of abstinence
Activation patterns associated with emotion processing, emotion regulation, craving and stress are determined in addicted cannabis users compared to non-using matched control subjects
1 secondary outcome
Timeline Followback Interviews
Time frame: one time point = 12 months after fMRI data acquisition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
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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.
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: status not confirmed, as of the sponsor's last update on 29 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Becker, PhD (+8618584070309, ben_becker@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI neural activation patterns of emotional processing (time frame: one time point = fMRI assessment after minimum 24 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 29 Oct 2018.