NCT03483220

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
2.9 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

March 20, 2018

Last Update Submit

January 10, 2022

Conditions

Addiction

Keywords

Addiction, MRI, emotional regulation

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    7 months

Study Arms (1)

cases

patients with cannabis use disorder

Diagnostic Test: MRI brain

Interventions

MRI brainDIAGNOSTIC_TEST

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
cases

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111, Egypt

Location

Related Publications (8)

  • 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.

    PMID: 26373849BACKGROUND

  • 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.

    PMID: 18829433BACKGROUND

  • 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.

    PMID: 16566899BACKGROUND

  • 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.

    PMID: 24636739BACKGROUND

  • 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.

    PMID: 24971265BACKGROUND

  • 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.

    PMID: 12916575BACKGROUND

  • 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.

    PMID: 29910014BACKGROUND

  • 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.

    PMID: 29691937BACKGROUND

MeSH Terms

Conditions

Behavior, AddictiveEmotional Regulation

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorSelf-ControlSocial Behavior

Study Officials

  • Khaled AM Elbeh, professor

    Assiut University

    STUDY CHAIR

  • Yasser M Elsorogy, professor

    Assiut University

    STUDY DIRECTOR

  • Gilan K Ramadan, Lecturer

    Assiut University

    STUDY DIRECTOR

  • Gehan S Seif, professor

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of psychiatry

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 30, 2018

Study Start

March 1, 2021

Primary Completion

September 30, 2021

Study Completion

December 20, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)