Comparison study of effectiveness of Matrix model,repetitive Transcranial Magnetic Stimulation and cognitive rehabilitation on decreasing of craving and assessment of dopamine receptors expression in peripheral blood lymphocytes of stimulant substance user.
Effectiveness of effective therapies for reducing craving in stimulant-dependent consumers
Design
The clinical trial group was divided into 3 intervention groups, each of which consisted of 10 subjects, simple randomized, two groups, pre-test and post-test
Settings and conduct
24, 45 minute sessions for every body in Matrix group and 15 sessions(each session: 40 minute) for everybody in cognitive rehabilitation group will be done in MMT center. 10 session of Repetitive Transcranial Magnetic Stimulation for every body in Iranian national center for addiction study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Written consent to participate in this study; The patients must use stimulant alone.
Exclusion Criteria: Alcoholic and other substance use patients; Psychotic, bipolar, antisocial, personality disorders and borderline patients; Multidrug abusers; Methadone users
Intervention groups
1. Matrix treatment (Intervention group)
2. Treatment with magnetic stimulation (Intervention group)
3. Treatment with Cognitive Rehab (Intervention group)
Main outcome variables
Change the status of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171004036553N2
Registration date:2018-04-13, 1397/01/24
Registration timing:registered_while_recruiting
Last update:2018-04-13, 1397/01/24
Update count:0
Registration date
2018-04-13, 1397/01/24
Registrant information
Name
Sahar Esmaili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 0651
Email address
saharesmaeili87@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison study of effectiveness of Matrix model,repetitive Transcranial Magnetic Stimulation and cognitive rehabilitation on decreasing of craving and assessment of dopamine receptors expression in peripheral blood lymphocytes of stimulant substance user.
Public title
Comparison study of effectiveness treatments on decreasing of craving of stimulant substance user.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sex: Male
Diagnosis of Substance use of the subjects
Having Satisfication of doing project
Exclusion criteria:
Using Methadon and the other drugs
Patients treated with alternative therapies other than methadone.
Patients with severe psychiatric disorders such as psychosis, bipolar depression.
Age
From 20 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using Dot Probe and Working memorey training software for clinical interventions
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Central Branch of Zanjan University of Medical Sciences, Beginning of the Islamic Republic Blvd., Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2017-08-08, 1396/05/17
Ethics committee reference number
ZUMS.REC.1396.96
Health conditions studied
1
Description of health condition studied
Stimulant Addiction
ICD-10 code
F15
ICD-10 code description
Other stimulant related disorders
Primary outcomes
1
Description
Crayving
Timepoint
Before the intervention after the end of the therapeutic interventions and 3 months later
Method of measurement
Questionnaires and cognitive tests
2
Description
Gene expression of dopamine receptors
Timepoint
Before the intervention after the end of the treatment interventions
Method of measurement
The real time pcr method
Secondary outcomes
1
Description
Anxiety Score
Timepoint
Before and after the intervention
Method of measurement
Anxiety Questionnaire
2
Description
Depression Score
Timepoint
Before and after the intervention
Method of measurement
Depression Questionnaire
3
Description
General Welbeing Score
Timepoint
Before and after the intervention
Method of measurement
General Welbeing Questionnaire
4
Description
Score of Crayving Assessment
Timepoint
Before and after the intervention
Method of measurement
Craving Assessment Questionnaire
5
Description
Screening Score and Addiction Severity Score
Timepoint
Before and after the intervention
Method of measurement
Screening and Measuring the Severity of Addiction
6
Description
Work Memory Score and Attention Detection
Timepoint
Before and after the intervention
Method of measurement
Work Memory and Detection Attention
Intervention groups
1
Description
"Intervention group 1: Outpatient psychotherapy method". In this intervention, the outpatient treatment method is used using a booklet therapy and cognitive behavioral assignments. The total number of sessions is 24 sessions per week and three times a week.
Category
Treatment - Other
2
Description
The "intervention group 2: cognitive rehabilitation" in this intervention uses cognitive programs to strengthen the two cognitive components of memory and attention.
Category
Rehabilitation
3
Description
"Intervention Group 3: By Brain Magnetic Stimulation" In this method, magnetic pulses are applied to the brain by magnetic resonance imaging (RTMS), causing activity of the neurons in the brain.