ClinicalTrials.gg
CompletedNCT03483220Updated Jan 25, 2022

Emotional Regulation, Impulsivity in Cannabis Its Relation to MRI Brain Structure

An observational study in Addiction, sponsored by Assiut University. Completed at 1 site in Egypt. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-01-25.

Primary conditionEmotional RegulationRegistry: Behavior, AddictiveReclassifiedWhy we changed it
Registry
Behavior, Addictive — the first condition term the registry derived for this study.
ClinicalTrials.gg
Emotional Regulation
Why
  1. Behavior, Addictive is a broad heading, used only when no more specific condition is named.
  2. The study's title name Emotional Regulation.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
66
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

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.

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Conditions studied

  • Addiction

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Keywords

  • Addiction, MRI, emotional regulation
03

In context

Emotional Regulation Reclassified

545 studies on the registry are indexed under Emotional Regulation; 188 are open to participants now.

This study's enrollment of 66 is below the median of 100 across 41 observational studies indexed under Emotional Regulation.

Browse Emotional Regulation studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Emotional Regulation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Behavior, Addictive. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

66 participants with cannabis use disorder diagnosed by DSM-5 criteria were recruited from addiction unit at Assiut University hospitals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age above 18 years.
  • Clearly consenting to participate in the study. . patient with substance use disorder

Exclusion criteria

Exclusion Criteria:

  • Intoxication or withdrawal state.
  • Comorbid Axis I psychiatric disorder.
  • any current or past neurological disorder.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
66 participants (actual)
Patient registry
No

Groups and cohorts

  • cases

    patients with cannabis use disorder

    Diagnostic Test: MRI brain

Interventions

  • Diagnostic testMRI brain

    1. 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.

    Also known as: Emotion Regulation Questionnaire (ERQ), UPPS-P Impulsive Behavior Scale, structured clinical interview

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 7 months

  2. 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

    Time frame: 7 months

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Study locations

1 site
  • Assiut University
    Assiut, 71111, Egypt
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References and documents

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 26373849 ↗
  • Schultz 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 18829433 ↗
  • Nestler 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 16566899 ↗
  • Cyders 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 24636739 ↗
  • Mohajerin 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 24971265 ↗
  • Gross 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 12916575 ↗
  • Jakubczyk 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 29910014 ↗
  • Gillespie 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in Sep 2021, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2018
First posted
Mar 30, 2018
StartActual
Mar 1, 2021
Primary completionActual
Sep 30, 2021
CompletionActual
Dec 20, 2021
Last update
Jan 25, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03483220
Lead sponsor
Assiut University
Responsible party
Sayed Mostafa (Lecturer of psychiatry, Assiut University) — Principal investigator
First posted
Mar 30, 2018
Start date
Mar 1, 2021
Primary completion
Sep 30, 2021
Completion
Dec 20, 2021
Last update
Jan 25, 2022

Study contacts

Khaled AM Elbeh, professor
study chair · Assiut University
Yasser M Elsorogy, professor
study director · Assiut University
Gilan K Ramadan, Lecturer
study director · Assiut University
Gehan S Seif, professor
study director · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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