1- efficacy of cue exposure therapy on craving reduction of patients with stimulant use disorder in comparison with control group.
2- efficacy of cue exposure therapy on reduction of addiction severity in patients with stimulant use disorder in comparison with control group.
3- efficacy of cue exposure therapy on relapse prevention in patients with stimulant use disorder in comparison with control group.
4- efficacy of cue exposure therapy on enhancement of quality of life in patients with stimulant use disorder in comparison with control group.
Design
this is a randomized control trial with control group and follow up. sample seize is 40, participants will allocated randomly into two groups with using statistical software
Settings and conduct
this study will be exert in Iranian national center of addiction study. participants are blind about random allocation
Participants/Inclusion and exclusion criteria
inclusion criteria: patients with stimulant use disorder diagnosis, having at least 18 years old, not using any kind of drug except of nicotin within 2 weeks before program starting, ability of reading and writing persian language, completion of informed consent form. exclusion criteria: if patient has severe physical illness, psychotic symptoms or suicidal ideations will be excluded from program.
Intervention groups
cue exposure therapy (CET) and treatment as usual (TAU)
Main outcome variables
primary outcome is: drug use reduction
secondary outcomes include: craving, self efficacy, addiction severity, quality of life and depression, anxiety and stress severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180218038782N1
Registration date:2018-09-09, 1397/06/18
Registration timing:registered_while_recruiting
Last update:2018-09-09, 1397/06/18
Update count:0
Registration date
2018-09-09, 1397/06/18
Registrant information
Name
Meghdad Talebizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1515
Email address
talebizadeh.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of cue exposure therapy on treatment outcome of stimulant use disorder
Public title
The efficacy of cue exposure therapy on treatment outcome of stimulant use disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
stimulant use disorder diagnosis
not using any kind of drug except of nicotine within two weeks before program starting
Ability of reading and writing persian language
Completion of informed consent form
Exclusion criteria:
having sever suicidal ideation
having psychotic symptoms
having acute physical problems
Age
From 18 years old to 64 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization by app or websites
Blinding (investigator's opinion)
Single blinded
Blinding description
patients will not get any informations about assignment process
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Iran univeristy of medical siences
Street address
Deputy of research and technology, Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,IRAN.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-03-18, 1396/12/27
Ethics committee reference number
9221521204
Health conditions studied
1
Description of health condition studied
stimulant use disorder
ICD-10 code
F15.2
ICD-10 code description
Other stimulant dependence
Primary outcomes
1
Description
treatment outcome includes: addiction severity, craving, relapse rate, quality of life and severity of depression, anxiety and stress that will be measured by addiction severity index (ASI), Desires for Drug Questionnaire (DDQ), Obsessive Compulsive Drug Use Scale (OCDUS), urine test, World Health Organization Quality of Life-Brief (WHOQOL-BREF) and Depression Anxiety Stress Scales (DASS-21).
Timepoint
assessment will complete at pre-test, post-test and follow up (3 months after treatment completion)
Method of measurement
addiction severity index (ASI), Desires for Drug Questionnaire (DDQ), Obsessive Compulsive Drug Use Scale (OCDUS), urine test, World Health Organization Quality of Life-Brief (WHOQOL-BREF) and Depression Anxiety Stress Scales (DASS-21).
Secondary outcomes
1
Description
addiction severity
Timepoint
pretest, post test, 3 months follow up
Method of measurement
addiction severity index (ASI)
2
Description
craving
Timepoint
pretest, post test, 3 months follow up
Method of measurement
Desires for Drug Questionnaire (DDQ) and Obsessive Compulsive Drug Use Scale (OCDUS).
3
Description
relapse rate
Timepoint
pretest, post test, 3 months follow up
Method of measurement
urine test
4
Description
quality of life
Timepoint
pretest, post test, 3 months follow up
Method of measurement
World Health Organization Quality of Life-Brief (WHOQOL-BREF)
5
Description
severity of depression, anxiety and stress
Timepoint
pretest, post test, 3 months follow up
Method of measurement
Depression Anxiety Stress Scales (DASS-21)
Intervention groups
1
Description
Intervention group: cue exposure treatment
Category
Behavior
2
Description
Control group: treatment as usual (TAU)
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian National Center for Addiction Studies
Full name of responsible person
Alireza Noroozi
Street address
No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 5541 5225
Email
talebizadeh.m86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
dr kazem malakouti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6655 1668
Email
talebizadeh.m86@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Meghdad Talebizadeh
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 1. Tehran Psychiatric Institute, School of Behavioral Sciences and Mental Health, mansouri ave, Niayesh st. satarkhan st. tehran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
talebizadeh.m86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Meghdad Talebizadeh
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 1. Tehran Psychiatric Institute, School of Behavioral Sciences and Mental Health, mansouri ave, Niayesh st. satarkhan st. tehran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
talebizadeh.m86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Meghdad Talebizadeh
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 1. Tehran Psychiatric Institute, School of Behavioral Sciences and Mental Health, mansouri ave, Niayesh st. satarkhan st. Tehran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
talebizadeh.m86@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all of data will be available with regard to confidentiality principle
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only for researchers
Under which criteria data/document could be used
those researchers interested to re analysis or doing meta analysis can request for receiving data
From where data/document is obtainable
to get data they should send a request to email address of Talebizadeh:
talebizadeh.m86@gmail.com
What processes are involved for a request to access data/document
researchers should note why they need data files and how they are going to use them.