AddictionNCT03483220
Emotional Regulation, Impulsivity in Cannabis Its Relation to MRI Brain Structure
An observational study of Addiction, run by Assiut University at 1 site in Egypt.
Trial summary
cannabis addiction is a major health hazard that has its effect on personality and behavior including the impulsivity and emotional regulation. It also has its effect on both the structure and function of different brain regions involved in brain reward system. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Addiction
- What is being tested?
- MRI brain
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 20 Dec 2021
- 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 45 years
- Men only
- Adult
Study population: 66 participants with cannabis use disorder diagnosed by DSM-5 criteria were recruited from addiction unit at Assiut University hospitals
Who may be able to join
- Age above 18 years.
- Clearly consenting to participate in the study. . patient with substance use disorder
Who cannot join
- Intoxication or withdrawal state.
- Comorbid Axis I psychiatric disorder.
- any current or past neurological disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation Between Emotional Regulation and Impulsivity in Cannabis Use Disorder and the Morphometric Changes in Brain Reward System Structures
cannabis addiction is a major health hazard that has its effect on personality and behavior including the impulsivity and emotional regulation. It also has its effect on both the structure and function of different brain regions involved in brain reward system.
the aim of the study is to study the emotional regulation and impulsivity among people with cannabis addiction studying the change in the volume of brain reward system structures' volume in relation to cannabis addiction and the change in the mentioned behavioral traits.
Read the detailed description
Introduction:
Cannabis sativa is a widely used drug comprising a broad spectrum of usage ranging from recreational users to chronic addicts.
Dependence on cannabis is considered a major global health related issue. Cannabis is still considered the most used psychoactive substance worldwide with an estimated 2.8-5.1 % of global adult population has used cannabis in 2019.
Epidemiological studies show that cannabis is the leading drug of abuse in Egypt and in Upper Egypt. Prevalence of cannabis dependence is estimated to be 7.4% in Egypt and 6.66 % in Upper Egypt.
Cannabis dependence is associated with multiple neurobehavioral abnormalities which can be considered as a psychological determinants of cannabis dependence .
There is an increasing evidence of association between emotional dysregulation and dependence on different substances of abuse. Such dysregulation affects both components of emotional regulation; reappraisal and suppression of emotions' expression. The pattern of this dysregulation differs according to the type of substance of dependence and can affect the pattern of substance abuse.
Impulsivity is a proposed endophenotype for substance dependence as well as a possible consequence of prolonged drug use. Drugs of addiction and subconscious craving are likely to increase impulsiveness due to the loss of frontal cortical inhibition of impulses and increased limbic drive. Cannabis use may lead to a loss of attention, reflection and inhibitory control.
Materials and Methods:
This cross-sectional study ran between at the addiction management unit, Assiut University, Egypt. Two groups of participants were recruited in the study: Group (A): 32 patients with cannabis used disorder diagnosed according to DSM-5 criteria recruited from the addiction outpatient clinic at the Hospital of Neurology and Psychiatry at Assiut University. Group (B): 34 healthy individuals as a cross matching control group.
Inclusion criteria were age above 18 years, current chronic cannabis dependence. Exclusion criteria were being in withdrawal state, other psychiatric disorders, and history or current neurological or medical disease.
Ethical considerations:
A signed, informed consent was obtained from patients and their families or caregivers to participate in the study. Confidentiality was maintained during the whole study.
Assessment tools:
All participants were first assessed through a semi-structured interview using the Structured clinical interviews for axis I diagnosis (SCID-I) to rule out any psychiatric comorbidities.
Emotion Regulation Questionnaire (ERQ): A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale.
UPPS-P Impulsive Behavior Scale- Short form: The UPPS-P impulsivity scale is a 20-item scale designed to assess five distinct personality traits to impulsive behavior: Negative Urgency, Lack of Perseverance, Lack of Premeditation, Positive Urgency and Sensation Seeking.
Magnetic resonance imaging examination:
The MR examination of brain was done using 1.5T MR scanner (Achieva, Philips Medical Systems, The Netherlands) with a 16 channel head coil without using any sedation.
- Conditions
- Addiction
- Being tested
- MRI brain
- Keywords
- Addiction, MRI, emotional regulation
- Medical subject headings
- Behavior, Addictive, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI brainDiagnostic test
Also called Emotion Regulation Questionnaire (ERQ), UPPS-P Impulsive Behavior Scale, structured clinical interview
- Emotion Regulation Questionnaire (ERQ): A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale .
UPPS-P Impulsive Behavior Scale- Short form: The UPPS-P impulsivity scale is a 20-item scale designed to assess five distinct personality traits to impulsive behavior: Negative Urgency, Lack of Perseverance, Lack of Premeditation, Positive Urgency and Sensation Seeking .
Magnetic resonance imaging examination:
The MR examination of brain was done using 1.5T MR scanner (Achieva, Philips Medical Systems, The Netherlands) with a 16 channel head coil without using any sedation.
| Study group | Role | What they receive |
|---|---|---|
| cases | patients with cannabis use disorder Receives: Diagnostic Test: MRI brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of impulsivity in addicts
the UPPS-P scale was used to measure the degree of impulsivity. it is a 20-item scale designed to assess five distinct personality traits to impulsive behavior: Negative Urgency, Lack of Perseverance, Lack of Premeditation, Positive Urgency and Sensation Seeking
Measured: 7 months
measuring the volume of prefrontal cortex in addicts
MRI brain with voxel based morphometry was used in measuring the volume of different brain regions involved in the brain reward system
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Mar 2021
- Primary completion30 Sep 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Mostafa, Assiut University
- Investigators
- Khaled AM Elbeh, professor, Study chair, Assiut UniversityYasser M Elsorogy, professor, Study director, Assiut UniversityGilan K Ramadan, Lecturer, Study director, Assiut UniversityGehan S Seif, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483220
- Sponsor's protocol ID
- MRI brain study in addiction
- Status last verified
- Jan 2022
- First submitted
- 20 Mar 2018
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Engel A, Caceda R. Can Decision Making Research Provide a Better Understanding of Chemical and Behavioral Addictions? Curr Drug Abuse Rev. 2015;8(2):75-85. doi: 10.2174/1874473708666150916113131.
PubMed 26373849Schultz W, Preuschoff K, Camerer C, Hsu M, Fiorillo CD, Tobler PN, Bossaerts P. Explicit neural signals reflecting reward uncertainty. Philos Trans R Soc Lond B Biol Sci. 2008 Dec 12;363(1511):3801-11. doi: 10.1098/rstb.2008.0152.
PubMed 18829433Nestler EJ, Carlezon WA Jr. The mesolimbic dopamine reward circuit in depression. Biol Psychiatry. 2006 Jun 15;59(12):1151-9. doi: 10.1016/j.biopsych.2005.09.018. Epub 2006 Mar 29.
PubMed 16566899Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav. 2014 Sep;39(9):1372-6. doi: 10.1016/j.addbeh.2014.02.013. Epub 2014 Mar 3.
PubMed 24636739Mohajerin B, Dolatshahi B, Pour Shahbaz A, Farhoudian A. Differences between expressive suppression and cognitive reappraisal in opioids and stimulant dependent patients. Int J High Risk Behav Addict. 2013 Jun;2(1):8-14. doi: 10.5812/ijhrba.8514. Epub 2013 Jun 26.
PubMed 24971265Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.
PubMed 12916575Jakubczyk A, Trucco EM, Kopera M, Kobylinski P, Suszek H, Fudalej S, Brower KJ, Wojnar M. The association between impulsivity, emotion regulation, and symptoms of alcohol use disorder. J Subst Abuse Treat. 2018 Aug;91:49-56. doi: 10.1016/j.jsat.2018.05.004. Epub 2018 May 31.
PubMed 29910014Gillespie NA, Neale MC, Bates TC, Eyler LT, Fennema-Notestine C, Vassileva J, Lyons MJ, Prom-Wormley EC, McMahon KL, Thompson PM, de Zubicaray G, Hickie IB, McGrath JJ, Strike LT, Renteria ME, Panizzon MS, Martin NG, Franz CE, Kremen WS, Wright MJ. Testing associations between cannabis use and subcortical volumes in two large population-based samples. Addiction. 2018 Apr 24:10.1111/add.14252. doi: 10.1111/add.14252. Online ahead of print.
PubMed 29691937
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Emotional Regulation and Impulsivity in Cannabis Use Disorder and the Morphometric Changes in Brain Reward System Structures
- ClinicalTrials.gov ID
- NCT03483220
- Acronym / sponsor ID
- MRI brain study in addiction
- Conditions
- Addiction
- Keywords
- Addiction, MRI, emotional regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 30 Mar 2018 (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 addiction is a major health hazard that has its effect on personality and behavior including the impulsivity and emotional regulation. It also has its effect on both the structure and function of different brain regions involved in brain reward system.
the aim of the study is to study the emotional regulation and impulsivity among people with cannabis addiction studying the change in the volume of brain reward system structures' volume in relation to cannabis addiction and the change in the mentioned behavioral traits.
Detailed description
Introduction:
Cannabis sativa is a widely used drug comprising a broad spectrum of usage ranging from recreational users to chronic addicts.
Dependence on cannabis is considered a major global health related issue. Cannabis is still considered the most used psychoactive substance worldwide with an estimated 2.8-5.1 % of global adult population has used cannabis in 2019.
Epidemiological studies show that cannabis is the leading drug of abuse in Egypt and in Upper Egypt. Prevalence of cannabis dependence is estimated to be 7.4% in Egypt and 6.66 % in Upper Egypt.
Cannabis dependence is associated with multiple neurobehavioral abnormalities which can be considered as a psychological determinants of cannabis dependence .
There is an increasing evidence of association between emotional dysregulation and dependence on different substances of abuse. Such dysregulation affects both components of emotional regulation; reappraisal and suppression of emotions' expression. The pattern of this dysregulation differs according to the type of substance of dependence and can affect the pattern of substance abuse.
Impulsivity is a proposed endophenotype for substance dependence as well as a possible consequence of prolonged drug use. Drugs of addiction and subconscious craving are likely to increase impulsiveness due to the loss of frontal cortical inhibition of impulses and increased limbic drive. Cannabis use may lead to a loss of attention, reflection and inhibitory control.
Materials and Methods:
This cross-sectional study ran between at the addiction management unit, Assiut University, Egypt. Two groups of participants were recruited in the study: Group (A): 32 patients with cannabis used disorder diagnosed according to DSM-5 criteria recruited from the addiction outpatient clinic at the Hospital of Neurology and Psychiatry at Assiut University. Group (B): 34 healthy individuals as a cross matching control group.
Inclusion criteria were age above 18 years, current chronic cannabis dependence. Exclusion criteria were being in withdrawal state, other psychiatric disorders, and history or current neurological or medical disease.
Ethical considerations:
A signed, informed consent was obtained from patients and their families or caregivers to participate in the study. Confidentiality was maintained during the whole study.
Assessment tools:
All participants were first assessed through a semi-structured interview using the Structured clinical interviews for axis I diagnosis (SCID-I) to rule out any psychiatric comorbidities.
Emotion Regulation Questionnaire (ERQ): A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale.
UPPS-P Impulsive Behavior Scale- Short form: The UPPS-P impulsivity scale is a 20-item scale designed to assess five distinct personality traits to impulsive behavior: Negative Urgency, Lack of Perseverance, Lack of Premeditation, Positive Urgency and Sensation Seeking.
Magnetic resonance imaging examination:
The MR examination of brain was done using 1.5T MR scanner (Achieva, Philips Medical Systems, The Netherlands) with a 16 channel head coil without using any sedation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases | – | Diagnostic Test: MRI brainpatients with cannabis use disorder |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- 66 participants with cannabis use disorder diagnosed by DSM-5 criteria were recruited from addiction unit at Assiut University hospitals
Key inclusion criteria (2 listed)
- Age above 18 years.
- Clearly consenting to participate in the study. . patient with substance use disorder
Key exclusion criteria (3 listed)
- Intoxication or withdrawal state.
- Comorbid Axis I psychiatric disorder.
- any current or past 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 |
|---|---|---|
| MRI brainAlso: Emotion Regulation Questionnaire (ERQ), UPPS-P Impulsive Behavior Scale, structured clinical interview1. Emotion Regulation Questionnaire (ERQ): A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale . UPPS-P Impulsive Behavior Scale- Short form: The UPPS-P impulsivity scale is a 20-item scale designed to assess five distinct personality traits to impulsive behavior: Negative Urgency, Lack of Perseverance, Lack of Premeditation, Positive Urgency and Sensation Seeking . Magnetic resonance imaging examination: The MR examination of brain was done using 1.5T MR scanner (Achieva, Philips Medical Systems, The Netherlands) with a 16 channel head coil without using any sedation. | Diagnostic test | cases |
Primary outcome
degree of impulsivity in addicts
Time frame: 7 months
the UPPS-P scale was used to measure the degree of impulsivity. it is a 20-item scale designed to assess five distinct personality traits to impulsive behavior: Negative Urgency, Lack of Perseverance, Lack of Premeditation, Positive Urgency and Sensation Seeking
measuring the volume of prefrontal cortex in addicts
Time frame: 7 months
MRI brain with voxel based morphometry was used in measuring the volume of different brain regions involved in the brain reward system
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 25 Jan 2022.
- Background: PubMed 26373849Engel A, Caceda R. Can Decision Making Research Provide a Better Understanding of Chemical and Behavioral Addictions? Curr Drug Abuse Rev. 2015;8(2):75-85. doi: 10.2174/1874473708666150916113131.
- Background: PubMed 18829433Schultz W, Preuschoff K, Camerer C, Hsu M, Fiorillo CD, Tobler PN, Bossaerts P. Explicit neural signals reflecting reward uncertainty. Philos Trans R Soc Lond B Biol Sci. 2008 Dec 12;363(1511):3801-11. doi: 10.1098/rstb.2008.0152.
- Background: PubMed 16566899Nestler EJ, Carlezon WA Jr. The mesolimbic dopamine reward circuit in depression. Biol Psychiatry. 2006 Jun 15;59(12):1151-9. doi: 10.1016/j.biopsych.2005.09.018. Epub 2006 Mar 29.
- Background: PubMed 24636739Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav. 2014 Sep;39(9):1372-6. doi: 10.1016/j.addbeh.2014.02.013. Epub 2014 Mar 3.
- Background: PubMed 24971265Mohajerin B, Dolatshahi B, Pour Shahbaz A, Farhoudian A. Differences between expressive suppression and cognitive reappraisal in opioids and stimulant dependent patients. Int J High Risk Behav Addict. 2013 Jun;2(1):8-14. doi: 10.5812/ijhrba.8514. Epub 2013 Jun 26.
- Background: PubMed 12916575Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.
- Background: PubMed 29910014Jakubczyk A, Trucco EM, Kopera M, Kobylinski P, Suszek H, Fudalej S, Brower KJ, Wojnar M. The association between impulsivity, emotion regulation, and symptoms of alcohol use disorder. J Subst Abuse Treat. 2018 Aug;91:49-56. doi: 10.1016/j.jsat.2018.05.004. Epub 2018 May 31.
- Background: PubMed 29691937Gillespie NA, Neale MC, Bates TC, Eyler LT, Fennema-Notestine C, Vassileva J, Lyons MJ, Prom-Wormley EC, McMahon KL, Thompson PM, de Zubicaray G, Hickie IB, McGrath JJ, Strike LT, Renteria ME, Panizzon MS, Martin NG, Franz CE, Kremen WS, Wright MJ. Testing associations between cannabis use and subcortical volumes in two large population-based samples. Addiction. 2018 Apr 24:10.1111/add.14252. doi: 10.1111/add.14252. Online ahead of print.
- 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.
Khaled AM Elbeh, professor study chair
Assiut University
Yasser M Elsorogy, professor study director
Assiut University
Gilan K Ramadan, Lecturer study director
Assiut 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 Addiction, run by Assiut University at 1 site in Egypt.
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 3 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 25 Jan 2022. 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 Egypt. 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?
degree of impulsivity in addicts (time frame: 7 months). The study lists 2 primary outcomes in all. 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 NCT03483220, which also lists 8 linked publications.
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 25 Jan 2022.