Guided smartphone-based treatment for patients in opioid maintenance treatment in Iran - transdiagnostic treatment for substance use and common mental disorders
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Protocol summary
Patients in the 8 addiction treatment center who are under the treatment, were randomly assigned to the intervention group (OMT+smartphone intervention) and control group (OMT) based on the designed protocol.
Patients in the 8 addiction treatment center in Tehran who are under the treatment, were randomly assigned to the intervention group (OMT+smartphone intervention) and control group (OMT) based on the designed protocol.
Patients in the 8 addiction treatment center in Tehran who are under the treatment, were randomly assigned to the intervention group (OMT+smartphone intervention) and control group (OMT) based on the designed protocol.
بیماران مراجعه کننده به هشت مرکز درمانی اختلالات مصرف مواد وارد این مطالعه می شوند. بیماران به صورت تصادفی وارد گروه های مطالعه شامل گروه مداخله (درمان معمول OMT+ مداخله از طریق تلفن هوشمند) و کنترل (درمان معمول OMT) می شوند.
بیماران مراجعه کننده به هشت مرکز درمانی اختلالات مصرف مواد در تهران وارد این مطالعه می شوند. بیماران به صورت تصادفی وارد گروه های مطالعه شامل گروه مداخله (درمان معمول OMT+ مداخله از طریق تلفن هوشمند) و کنترل (درمان معمول OMT) می شوند.
بیماران مراجعه کننده به هشت مرکز درمانی اختلالات مصرف مواد در تهران وارد این مطالعه می شوند. بیماران به صورت تصادفی وارد گروه های مطالعه شامل گروه مداخله (درمان معمول OMT+ مداخله از طریق تلفن هوشمند) و کنترل (درمان معمول OMT) می شوند.
Inclusion Criteria:
To provide written informed consent
Minimal age of 18 years
Diagnosis of opioid dependence
Stable methadone or buprenorphine dosage for at least 3 weeks
Ownership of a smartphone and a valid email address
Good command of Persian
Appropriate geographical access to the study site in Tehran
Exclusion Criteria
Concurrent benzodiazepine, (meth-)amphetamine, or cocaine dependence
Current pharmacologically-treated severe psychiatric diseases
Inclusion Criteria:
To provide written informed consent;
Minimal age of 18 years;
Diagnosis of opioid dependence;
Stable methadone or buprenorphine dosage for at least 3 weeks;
Ownership of a smartphone and a valid email address;
Good command of Persian;
Appropriate geographical access to the study site in Tehran.
Exclusion Criteria:
Concurrent benzodiazepine, (meth-)amphetamine, or cocaine dependence;
Current pharmacologically-treated severe psychiatric diseases.
Inclusion Criteria: To provide written informed consent; Minimal age of 18 years; Diagnosis of opioid dependence; Stable methadone or buprenorphine dosage for at least 3 weeks; Ownership of a smartphone and a valid email address; Good command of Persian; Appropriate geographical access to the study site in Tehran. Exclusion Criteria: Concurrent benzodiazepine, (meth-)amphetamine, or cocaine dependence; Current pharmacologically-treated severe psychiatric diseases.
شرایط ورود:
پر کردن رضایت نامه کتبی
حداقل سن 18 سال
تشخیص وابستگی به مواد افیونی
تثبیت روی درمان با متادون یا بوپرنورفین ثابت برای حداقل 3 هفته
داشتن یک تلفن همراه هوشمند و یک آدرس ایمیل معتبر
تسلط خوب به زبان فارسی
دسترسی مناسب جغرافیایی به سایت مطالعه در تهران
شرایط عدم ورود
وابستگی همزمان به بنزودیازپین، (مت-) آمفتامین یا کوکائین
بیماری های روانپزشکی شدید تحت درمان دارویی
شرایط ورود:
پر کردن رضایت نامه کتبی؛
حداقل سن 18 سال؛
تشخیص وابستگی به مواد افیونی؛
تثبیت روی درمان با متادون یا بوپرنورفین ثابت برای حداقل 3 هفته؛
داشتن یک تلفن همراه هوشمند و یک آدرس ایمیل معتبر؛
تسلط خوب به زبان فارسی؛
دسترسی مناسب جغرافیایی به سایت مطالعه در تهران.
شرایط عدم ورود:
وابستگی همزمان به بنزودیازپین، (مت-) آمفتامین یا کوکائین؛
بیماری های روانپزشکی شدید تحت درمان دارویی.
شرایط ورود: پر کردن رضایت نامه کتبی؛ حداقل سن 18 سال؛ تشخیص وابستگی به مواد افیونی؛ تثبیت روی درمان با متادون یا بوپرنورفین ثابت برای حداقل 3 هفته؛ داشتن یک تلفن همراه هوشمند و یک آدرس ایمیل معتبر؛ تسلط خوب به زبان فارسی؛ دسترسی مناسب جغرافیایی به سایت مطالعه در تهران. شرایط عدم ورود: وابستگی همزمان به بنزودیازپین، (مت-) آمفتامین یا کوکائین؛ بیماری های روانپزشکی شدید تحت درمان دارویی.
General information
2021-04-21, 1400/02/01
2023-10-23, 1402/08/01
20212023-0410-2123 00:00:00
2022-04-21, 1401/02/01
2024-10-22, 1403/08/01
20222024-0410-2122 00:00:00
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Change planning for implementation
Change planning for implementation
empty
تغییر برنامه ریزی برای اجرا
تغییر برنامه ریزی برای اجرا
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ghazal Mousavian
Full name of responsible person - Persian: غزال موسویان
Position - English: Epidemiologist
Position - Persian: اپیدمیولوژیست
Latest degree: master
Area of specialty/work: 2
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 486, South Kargar Avenue, Qazvin Square
Street address - Persian: خیابان کارگر جنوبی پایین تر از میدان قزوین پلاک 486
City - English: Tehran
City - Persian: Tehran
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1635713366
Phone: +98 21 5542 3751
Mobile: +98 916 904 2110
Fax:
Email: gh.msv72@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Eisa Naghizadeh
Full name of responsible person - Persian: عیسی نقی زاده
Position - English: Clinical psychologist (addiction therapist)
Position - Persian: روانشناس بالینی (درمانگر اعتیاد)
Latest degree: master
Area of specialty/work: 48
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 486, South Kargar Avenue, Qazvin Square
Street address - Persian: خیابان کارگر جنوبی پایین تر از میدان قزوین پلاک 486
City - English: Tehran
City - Persian: Tehran
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1635713366
Phone: +98 21 5542 3751
Mobile: +98 935 181 0984
Fax:
Email: naghizadeh2020@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ghazal MousavianEisa Naghizadeh Full name of responsible person - Persian: غزال موسویانعیسی نقی زاده Position - English: EpidemiologistClinical psychologist (addiction therapist) Position - Persian: اپیدمیولوژیستروانشناس بالینی (درمانگر اعتیاد) Latest degree: master Area of specialty/work: 248 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No 486, South Kargar Avenue, Qazvin Square Street address - Persian: خیابان کارگر جنوبی پایین تر از میدان قزوین پلاک 486 City - English: Tehran City - Persian: Tehran Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1635713366 Phone: +98 21 5542 3751 Mobile: +98 916 904 2110935 181 0984 Fax: Email: gh.msv72naghizadeh2020@gmail.comyahoo.com Web page address:
Protocol summary
Study aim
To examine the effectiveness of a newly-developed, culturally-adapted gender-sensitive integrated Community Reinforcement Approach- and Cognitive Behavioral Therapy-based guided smartphone intervention in Opioid maintenance therapy patients in Iran.
Design
After a detailed gender-sensitive iterative pilot and validation process, the final PROMPT version (Study arm 1) will be compared with OMT as usual (Study arm 2) in a randomized controlled trial (RCT) within 400 opioid-dependent patients at eight treatment centers.
Settings and conduct
Patients in the 8 addiction treatment center in Tehran who are under the treatment, were randomly assigned to the intervention group (OMT+smartphone intervention) and control group (OMT) based on the designed protocol.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
To provide written informed consent;
Minimal age of 18 years;
Diagnosis of opioid dependence;
Stable methadone or buprenorphine dosage for at least 3 weeks;
Ownership of a smartphone and a valid email address;
Good command of Persian;
Appropriate geographical access to the study site in Tehran.
Exclusion Criteria:
Concurrent benzodiazepine, (meth-)amphetamine, or cocaine dependence;
Current pharmacologically-treated severe psychiatric diseases.
Intervention groups
The intervention group will receive an integrated Community Reinforcement Approach, motivational interviewing, and CBT-based guided smartphone intervention (PROMPT) added to OMT as usual.
The control group will receive OMT as usual, as in the intervention group, but without the smartphone intervention.
Main outcome variables
Weekly negative urine tests for morphine
General information
Reason for update
Change planning for implementation
Acronym
IRCT registration information
IRCT registration number:IRCT20170702034844N8
Registration date:2021-02-21, 1399/12/03
Registration timing:prospective
Last update:2023-06-17, 1402/03/27
Update count:2
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
Alireza Noroozi
Name of organization / entity
Iranian National Center for Addiction Studies (INCAS)
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 1144
Email address
noroozi_a@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Guided smartphone-based treatment for patients in opioid maintenance treatment in Iran - transdiagnostic treatment for substance use and common mental disorders
Public title
Guided smartphone-based treatment for patients in opioid maintenance treatmen
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent
Minimal age of 18 years
Stabilization on methadone or buprenorphine dosage for at least 3 weeks
Ownership of a smartphone and a valid email address
Good command of Persian
Appropriate geographical access to the study site in Tehran
Exclusion criteria:
Concurrent benzodiazepine, (meth-)amphetamine, or cocaine dependence
Current pharmacologically-treated severe psychiatric disease, like schizophrenia or bipolar type I disorder, or significant current suicidal or homicidal thoughts
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
400
Randomization (investigator's opinion)
Randomized
Randomization description
Random codes are created by the person responsible for data randomization using a computer program. Patients are randomly allocated to either the treatment or control group in a 1:1 ratio based on random sequence blocks with a block size of 4.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research School of Medicine - Tehran University of Medical Sciences
Street address
Building No. 1, Faculty of Medicine, First Floor, Office of the Vice Chancellor for Research, Ghods St., Enghelab St
City
Tehran
Province
Tehran
Postal code
1635713366
Approval date
2020-11-03, 1399/08/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.714
Health conditions studied
1
Description of health condition studied
Moderate to severe opioids use disorder
ICD-10 code
F11.2
ICD-10 code description
Opioid dependence
Primary outcomes
1
Description
Weekly negative urine tests for morphine
Timepoint
Between each measurement point (months 1-3, months 6 and 12 )
Method of measurement
Urine rapid test
Secondary outcomes
1
Description
Days of opium use during last 30 days
Timepoint
At the baseline and 3-, 6- and 12-month follow-up.
Method of measurement
Self report
2
Description
Days of heroin use during last month
Timepoint
At the baseline and 3-, 6- and 12-month follow-up.
Method of measurement
Self report
3
Description
Days of tramadol use during last month
Timepoint
At the baseline and 3-, 6- and 12-month follow-up.
Method of measurement
Self report
4
Description
Severity of opioid dependence
Timepoint
At the baseline and 3-, 6- and 12-month follow-up.
Method of measurement
Severity of Drug Dependence Scale
5
Description
Score of drug abuse screening
Timepoint
At the baseline and 3-, 6- and 12-month follow-up.
Method of measurement
DAST-10 Test
6
Description
Changes in communicable disease risk-taking behaviors
Timepoint
At the baseline and 3-, 6- and 12-month follow-up.
At the baseline and 3-, 6- and 12-month follow-up.
Method of measurement
PSS-10 Questionnaire
8
Description
Other common mental disorder symptoms
Timepoint
At the baseline and 3-, 6- and 12-month follow-up.
Method of measurement
PHQ-9,GAD-7, PTSD, CSQ-8 Questionnaires.
Intervention groups
1
Description
Intervention group: The intervention group will receive an integrated community reinforcement approach, motivational interviewing, and cognitive, behavioral treatment-based guided smartphone intervention (called PROMPT for Promoting Recovery in Opioid Maintenance and PsychosocialTreatments) added to opioid maintenance treatment (OMT).
Category
Behavior
2
Description
Control group: Control group will receive opioid maintenance treatment with methadone or buprenorphine based on national protocols.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian National Center for Addiction Studies' Clinic
Full name of responsible person
Alireza Noroozi
Street address
No 486, South Kargar Street, Qazvin Square
City
Tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5542 1144
Email
a_r_noroozi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Swiss Research Institute of Public Health and Addiction (ISGF)
Full name of responsible person
Michael Schaub
Street address
Konradstrasse 32 8005 Zurich, Swiss Research Institute of Public Health and Addiction ISGF, a WHO Collaborating Centre, associated with the University of Zurich
City
Zurich
Postal code
8031
Phone
+41 44 448 11 65
Fax
+41 44 448 11 70
Email
michael.schaub@isgf.uzh.ch
Web page address
https://www.isgf.uzh.ch/de.html
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Swiss National Science Foundation
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
CH
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iranian National Center for Addiction Studies (INCAS)
Full name of responsible person
Alireza Noroozi
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 486, South Kargar Street, Qazvin Square
City
Tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5542 1144
Email
a_r_noroozi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Afarin Rahimi-Movaghar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 486, South Kargar Street, Qazvin Square
City
Tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5542 3751
Email
rahimia@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Eisa Naghizadeh
Position
Clinical psychologist (addiction therapist)
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 486, South Kargar Avenue, Qazvin Square
City
Tehran
Province
Tehran
Postal code
1635713366
Phone
+98 21 5542 3751
Fax
Email
naghizadeh2020@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
It is planned to share IPD, study protocol and report of the clinical study.
When the data will become available and for how long
IPD will be shared after completion of the data gathering phase. Study protocol will be available within 3 months after successful registration of the trial. Report of the clinical study will be finalized at the end of study
To whom data/document is available
Clinical researchers
Under which criteria data/document could be used
IPD will be available for researchers who are conducting review studies. The study protocol and report will be published as English articles.
From where data/document is obtainable
Email to the individual who is responsible for scientific inquiries of this project
What processes are involved for a request to access data/document
It will be responded after processing within the project team.