Cannabis UseNCT03162640
Impulsivity and Time Perception
An observational study of Cannabis Use, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Cannabis smokers having begun prematurely their consumption (before 16 years) present a persistent impulsivity much later after have stopped their consumptions. The literature highlights that the impulsivity promotes the passage towards a compulsive consumption, and the loss of control. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2017to 12 Mar 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Cannabis use Versus Non-smokers
Who may be able to join
- Healthy volunteers Man or woman of age between 18 and 50 years-old
- Absence of consumption of cannabis and tobacco for 1 year and absence of substance use disorder in history
- Matching in age and sex to the group consumers of cannabis
- Early consumers of cannabis (at the beginning of the consumptions before 16 years)
- Man or woman of age between 18 and 50 years old
- Statement of more than three consumptions a day of cannabis for at least one year and consumption of cannabis having begun before the age of 16 years.
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- Urinary analysis is positive for the presence of cannabis
- Positive auto-questionnaire CAST: 2 positive answers to CAST questionnaire
- Hospitalized or not
Who cannot join
- Presence or history of a severe and invalidating somatic pathology (neurological, cardiovascular, lung, metabolic, renal, hepatic, gastro-intestinal)
- History of cranial trauma with loss of consciousness.
- substance use disorder except the substance tested in the protocol (cannabis).
- Invalidating sensory disorders in particular visual: glaucoma, any retinal pathology. Visual acuteness 0.8
- History of general anesthesia in the previous 3 months the study
- Any evolutionary neurological or psychiatric pathology
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- Subject under guardianship
- pregnancy
- Feeding
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, 67091
About this study
Official title: Link Between Impulsivity and Time Anticipation
Cannabis smokers having begun prematurely their consumption (before 16 years) present a persistent impulsivity much later after have stopped their consumptions. The literature highlights that the impulsivity promotes the passage towards a compulsive consumption, and the loss of control. To explain this phenomenon, some authors hypothesized that impulsivity would lead the subjects to overestimate the duration of events and to choose immediate rewards than preferred but delayed rewards. This hypothesis questions the role of the temporal anticipation in the impulsive choices. In a first hypothesis, the temporal impulsivity could be an endogenous deficit bound to the reward, and would be responsible for disorders of the temporal anticipation. In this case, the disorders should be observed especially when the subject anticipates a reward. Alternately, a disorder of the temporal anticipation could provoke impulsivity, and in this case, would be present with or without reward. To separate these hypotheses, we propose to test the capacities of temporal anticipation of non-smokers and early smokers of cannabis by means of a behavioral task " Hazard function task ", which allow to measure the capacity of a subject to anticipate the apparition of an event on the basis of a temporal cue. The neuronal correlates will be measured by a recording EEG of the wave ' CNV ' (fix a quota for denial of variation) which reflects the temporal accumulation and the processes of anticipation.
- Conditions
- Cannabis Use
- Keywords
- Early onset of cannabis use, Addiction, Time perception
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| P | for cannabis | |
| C | for the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the capacities of the subjects to anticipate the apparition of the target
on the basis of a temporal cue presented before the target, and give the response as quickly as possible after the presentation of a rewarding versus not rewarding target.
Measured: 8 days after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start5 May 2017
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
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.
- 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence LALANNE-TONGIO, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162640
- Sponsor's protocol ID
- 6526
- Status last verified
- May 2017
- First submitted
- 19 May 2017
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Link Between Impulsivity and Time Anticipation
- ClinicalTrials.gov ID
- NCT03162640
- Acronym / sponsor ID
- 6526
- Conditions
- Cannabis Use
- Keywords
- Early onset of cannabis use, Addiction, Time perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 22 May 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.
Cannabis smokers having begun prematurely their consumption (before 16 years) present a persistent impulsivity much later after have stopped their consumptions. The literature highlights that the impulsivity promotes the passage towards a compulsive consumption, and the loss of control. To explain this phenomenon, some authors hypothesized that impulsivity would lead the subjects to overestimate the duration of events and to choose immediate rewards than preferred but delayed rewards. This hypothesis questions the role of the temporal anticipation in the impulsive choices. In a first hypothesis, the temporal impulsivity could be an endogenous deficit bound to the reward, and would be responsible for disorders of the temporal anticipation. In this case, the disorders should be observed especially when the subject anticipates a reward. Alternately, a disorder of the temporal anticipation could provoke impulsivity, and in this case, would be present with or without reward. To separate these hypotheses, we propose to test the capacities of temporal anticipation of non-smokers and early smokers of cannabis by means of a behavioral task " Hazard function task ", which allow to measure the capacity of a subject to anticipate the apparition of an event on the basis of a temporal cue. The neuronal correlates will be measured by a recording EEG of the wave ' CNV ' (fix a quota for denial of variation) which reflects the temporal accumulation and the processes of anticipation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P | – | –for cannabis |
| C | – | –for the control group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cannabis use Versus Non-smokers
Key inclusion criteria (9 listed)
- Healthy volunteers Man or woman of age between 18 and 50 years-old
- Absence of consumption of cannabis and tobacco for 1 year and absence of substance use disorder in history
- Matching in age and sex to the group consumers of cannabis
- Early consumers of cannabis (at the beginning of the consumptions before 16 years)
- Man or woman of age between 18 and 50 years old
Key exclusion criteria (9 listed)
- Presence or history of a severe and invalidating somatic pathology (neurological, cardiovascular, lung, metabolic, renal, hepatic, gastro-intestinal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the capacities of the subjects to anticipate the apparition of the target
Time frame: 8 days after inclusion in the study
on the basis of a temporal cue presented before the target, and give the response as quickly as possible after the presentation of a rewarding versus not rewarding target.
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 29 Aug 2023.
- 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. This study is not recruiting at the moment.
Laurence LALANNE-TONGIO, MD principal investigator
Hôpitaux Universitaires de Strasbourg
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 Use, run by University Hospital, Strasbourg, France at 1 site in France.
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 9 inclusion and 9 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 29 Aug 2023. 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 France. 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?
Measure the capacities of the subjects to anticipate the apparition of the target (time frame: 8 days after inclusion in the study). 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 Aug 2023.