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Screening, Brief Intervention and Referral to Treatment (SBIRT) for Patients with Screen Positive for Alcohol and Drug Dependence among Referrals of Emergency Department

Protocol summary

Study aim
Efficacy of Screening, Brief Intervention and Referral to Treatment (SBIRT) for Patients Screened Positive for Alcohol and Drug Dependence among Referrals of Emergency Department
Design
This is a randomized clinical, controlled, parallel groups, randomized, phase 2 trial. In this study, 100 participants will randomly assigned to study groups using a random sequence generation of quadrilateral block.
Settings and conduct
Emergency department, Loghman Hakim Hospital Research assistants refer to the emergency department in the morning shift and with the help of the head nurse, will select individuals who meet eligibility criteria and enroll them to the study after providing written informed concent.
Participants/Inclusion and exclusion criteria
Inclusion criteria: (1) age 18 to 65 years old, (2) admission to emergency department ward with alcohol and drug intoxication, (3) screen positive for alcohol and drug (opioids, methamphetamine) dependence, (4) medical stabilization, (5) ability to read and write, (6) provide written informed consent. Exclusion criteria: (1) Risk of suicide, homicide or violence, (2) psychosis, (3) inability to understand study protocol and complete assessments.
Intervention groups
Control group: Treatment as usual + brochure on importance and availability of alcohol and drug (opioids, methamphetamine) treatment in Psychiatric Clinic, Iranian National Center for Addiction Studies (INCAS) Intervention group: Treatment as usual+ brief motivational intervention aiming at referral to Psychiatric Clinic, Iranian National Center for Addiction Studies (INCAS) + telephone follow-up within 1 week of discharge
Main outcome variables
Percent of study participants referred to Psychiatric Clinic, Iranian National Center for Addiction Studies, within 1 month of discharge

General information

Reason for update
Acronym
ED-SBIRT
IRCT registration information
IRCT registration number: IRCT20170702034844N4
Registration date: 2019-06-16, 1398/03/26
Registration timing: prospective

Last update: 2019-06-16, 1398/03/26
Update count: 0
Registration date
2019-06-16, 1398/03/26
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
2019-06-22, 1398/04/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Screening, Brief Intervention and Referral to Treatment (SBIRT) for Patients with Screen Positive for Alcohol and Drug Dependence among Referrals of Emergency Department
Public title
Screening, Brief Intervention and Referral to Treatment (SBIRT) for Patients with Screen Positive for Alchohol and Drug Dependence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Admission to the Emergency Department of Poisoning Hospital Detection of alcohol or drug intoxication (opioids, methamphetamine) age 18-65 Stabilization from a medical point of view Informed Consent to Enter Study Literacy reading and writing Positive screening for alcohol dependence using AUDIT, Drug dependence using ASSIST and diagnosis of alcohol and drug dependence based on ICD-10 criteria
Exclusion criteria:
The risk of suicide, abuse or violence Occurrence of psychosis Failure to understand the study protocol and answer the questionnaires Participation in another intervention research project
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Using a random sequence generation, a quadrilateral block is used with a random number table. Allocation: By a third-party supervisor who is a physician at the National Center for Addictive Studies, and coordinating the placement of each referral in each treatment group.
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 of Tehran University of Medical Sciences (TUMS), Vice-Chancellor for Research
Street address
6th Floor, Central Building of Tehran University of Medical Sciences (TUMS), Ghods St., Keshavarz Blv. Tehran, Iran, Islamic Republic Of
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-05-21, 1398/02/31
Ethics committee reference number
IR.TUMS.VCR.REC.1398.160

Health conditions studied

1

Description of health condition studied
Alchohol dependence
ICD-10 code
F10.2
ICD-10 code description
Mental and behavioural disorders due to use of alcohol: dependence syndrome

2

Description of health condition studied
Opioids dependence
ICD-10 code
F11.2
ICD-10 code description
Mental and behavioural disorders due to use of opioids: dependence syndrome

3

Description of health condition studied
Stimulants (methamphetamine) dependence
ICD-10 code
F15.2
ICD-10 code description
Mental and behavioural disorders due to use of stimulants: dependence syndrome

Primary outcomes

1

Description
Percent of successful referral to specialized substance treatment center within 1 month of discharge
Timepoint
One week and 1 month after discharge
Method of measurement
Registration of clients referred to Psychiatric Clinic, Iranian National Center for Addiction Studies through this project

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in this group who screened positive for alcohol and drug dependence (opioids and methamphetamine) using AUDIT and ASSIST questionnaires and have a diagnosis of alcohol and drug dependence based on ICD-10, will receive treatment as usual and one 20-30 minutes brief motivational intervention by trained clinical psychologist aiming at referral to Psychiatric Clinic, Iranian National Center for Addiction Studies for further assessment and treatment. Participants will also receive one telephone follow-up within one week of discharge in order to remind them for referral.
Category
Behavior

2

Description
Control group: Treatment as usual for medical and psychiatric stabilization in emergency department ward plus a brochure on importance and availability of alcohol and drug (opioids and methamphetamine) treatment in Psychiatric Clinic, Iranian National Center for Addiction Studies (INCAS)
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency ward, Loghman Hakim Hospital
Full name of responsible person
Dr. Alireza Noroozi
Street address
No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital
City
TEHRAN
Province
Tehran
Postal code
664 - 14145
Phone
+98 21 5542 1144
Email
a_r_noroozi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for Research, Tehran University of Medical Sciences
Full name of responsible person
Ms. Karimi
Street address
6th Floor, Deputy for Research, Central Building of Tehran University of Medical Sciences (TUMS), Ghods St., Keshavarz Blv.
City
TEHRAN
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3616
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Alireza Noroozi
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital
City
tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5541 5225
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
Dr. Alireza Noroozi
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital
City
Tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5541 5225
Email
a_r_noroozi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Alireza Noroozi
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No 486, South Kargar St., Qazvin Sq., Next to Farabi Hospital
City
tehran
Province
Tehran
Postal code
1336616357
Phone
+98 21 5541 5225
Email
a_r_noroozi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
No - There is not 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
Participants data file: The participants data without identifying information will be available after completion of the study. Clinical study report: The clinical study report will be available after completion of the study.
When the data will become available and for how long
September 2019
To whom data/document is available
Researchers of psychiatric disorders clinical studies
Under which criteria data/document could be used
Using study data for systematic reviews and meta-analysis studies ispermitted.
From where data/document is obtainable
Dr. Alireza Noroozi Psychiatric Clinic, Iranian National Center for Addiction Studies (INCAS) Address: No 486, South Kargar St, Tehran, Iran Email: a_r_noroozi@yahoo.com
What processes are involved for a request to access data/document
The data request need to clearly define data needs. The study contact person will provide available data within 1 week after receiving the req
Comments
None
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