A randomized clinical trial comparing the efficacy of cognitive behavioral therapy on drug use control and treatment among women drug users on Maintaining Methadone Therapy (MMT)
Objective: The purpose of this study is to determine the impact of a brief cognitive- behavioral therapy on drug control use and treatment among female drug users on Maintaining Methadone Therapy (MMT). The main inclusion and exclusion criteria: Addicted women with age range 18-55 years with a history of at least 3 times drug use during previous month, being on methadone maintenance therapy and without any implications of any severe personality and neurological disorders. Study participants and sample size: Forty women will be selected voluntarily among patients referring to Methadone Maintaining Treatment centers (MMT) and will be divided into two control (n=20) and experimental group (n=20). Design: Proposed intervention will be randomized control trial with random allocation into control and intervention groups. Interventions: A brief cognitive behavioral intervention (one month, one 2-hour session per week) will be used. The study will be conducted at three stages including baseline, intervention and follow up after 3 months. Primary outcome measure: Two groups will be compared regarding the effectiveness of intervention program on reducing relapse rate at three stages.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060621684N2
Registration date:2015-08-30, 1394/06/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-30, 1394/06/08
Registrant information
Name
Mahmood AminiLari
Name of organization / entity
Shiraz HIV/AIDS Research Center, Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3738 6272
Email address
aminlari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial comparing the efficacy of cognitive behavioral therapy on drug use control and treatment among women drug users on Maintaining Methadone Therapy (MMT)
Public title
The effect of cognitive- behavioural therapy on drug use control and treatment among addicted female
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Being addicted female; being on methadone maintaining therapy for at least 3 months; having a history of relapse during MMT program for at least 3 times over the past one month; completing inform consent; having not a history of severe drug toxicity.
Exclusion criteria: Having severe physical and neurological illness;Having severe mental and personality disorders.
Age
From 18 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
The Ethics Committee, Shiraz University of Medical Sciences
Street address
7th Floor, Central Building, Shiraz University of Medical Sciences, Zand Ave, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
IR.SUMS.REC.1394.45
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
F19
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use
Primary outcomes
1
Description
Retention in Methadone Maintenance Treatment without relapse
Timepoint
Before intervention, immediately after intervention, 3 months after intervention
Method of measurement
Opium treatment index; severity of dependence scale; timeline follow back; rapid urine test
Secondary outcomes
1
Description
The trend of reducing in drug use
Timepoint
Before intervention, immediately after intervention, 3 months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Experimental Group: Brief cognitive and behavioural therapy. This guide, reported by Baker et al 2003, details a brief cognitive behavioural intervention specifically designed for regular amphetamine users that may be utilized by practitioners working in a wide range of treatment settings.
Category
Behavior
2
Description
Control Group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Drop in Center, Methadone Maintenance Therapy Center
Full name of responsible person
Hamid Reza Bakhtiyari
Street address
Sang-e Siyah Sector, Gode Araban Street, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Poostfroosh
Street address
7th Floor, Central Building, Shiraz University of Medical Sciences, Zand Ave, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz HIV/ AIDS Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Mahmood AminiLari
Position
Executive Director
Other areas of specialty/work
Street address
2nd floor, Voluntary Counseling and Testing Center, Lavan Ave, Delavaran-e Basij Blvd, Khatoun Sq, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3738 6272
Fax
Email
maminil@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
National Drug and Alcohol Research Centre, Faculty of Public Health and Community Medicine, Universi
Full name of responsible person
Zahra Alam Mehrjerdi
Position
PHD student of addiction
Other areas of specialty/work
Street address
National Drug and Alcohol Research Centre, Faculty of Public Health and Community Medicine, University of New South Wales, Sydney, Australia
City
Sydney
Province
New South Wales
Postal code
Phone
006128936100
Fax
Email
a.mehrjerdi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz HIV/AIDS Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Mahmood AminiLari
Position
Executive Director/ MA
Other areas of specialty/work
Street address
2nd floor, Voluntary Counselling and Testing Center, Lavan Ave, Delavaran-e Basij Blvd, Khatoun Sq, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3738 6272
Fax
Email
maminil@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)