This study will be done with aim to determine the effect of neurofeedback therapy in reducing relapse and craving for methamphetamine dependent patients in Kermanshah city. This study is a single blinded clinical trial. The study population will consisted of all methamphetamine patients men that refer to Farabi Hospital in Kermanshah that 100 persons will selected in available method and randomly will be divided into two groups (50 patients exprimental group and 50 patients in control group).The exprimental and control group will completed the relapse and craving questionnaires. The experimental group will received 30 sessions of 50 minutes will be treated with neurofeedback and control group would be shamn eurofeedback . After 4 and 8 weeks participants will complete the questionnaires again. Inclusion criteria: Gender Male; Methamphetamine dependence diagnoses accordingly Diagnostic and Statistical Manual of Mental Disorders fifth edition; The dominant use of methamphetamine for at least 6 months, lack of serious psychiatric disorders. Exclusion criteria: Gender female; No use of other drugs and stimulants at the time of entering the study; The absence of comorbid psychiatric disorders symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021828967N5
Registration date:2017-03-01, 1395/12/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Safora Salemi
Name of organization / entity
Shahid Chamran University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 83 3821 1001
Email address
e.mahmoudi@cobeldarou.com
Recruitment status
Recruitment complete
Funding source
Ethics committee of Kermanshah University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neurofeedback therapy in reducing relapse and craving for methamphetamine dependent patients
Public title
The effect of neurofeedback therapy in reducing relapse and craving for methamphetamine dependent patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gender Male; Methamphetamine dependence diagnoses accordingly Diagnostic and Statistical Manual of Mental Disorders fifth edition; The dominant use of methamphetamine for at least 6 months, lack of serious psychiatric disorders. Exclusion criteria: Gender female; No use of other drugs and stimulants at the time of entering the study; The absence of comorbid psychiatric disorders symptoms.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti Blvd, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2017-01-11, 1395/10/22
Ethics committee reference number
kums.rec.1395.607
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
F15
ICD-10 code description
Mental and behavioral disorders due to use of other stimulants, including caffeine: dependence syndromes
Primary outcomes
1
Description
Relapse
Timepoint
before intervention- 4 weeks later- 8 weeks later
Method of measurement
Relapse Questionnaire
2
Description
Craving
Timepoint
before intervention- 4 weeks later- 8 weeks later
Method of measurement
Craving Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group will receive neurofeedback treatment in 30 sessions.
Category
Treatment - Other
2
Description
The control group will receive unrealistic neurofeedback therapy in 30 sessions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti Blvd, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Psychiatrist
Other areas of specialty/work
Street address
Farabi Hospital, Isar square
City
Kermanshah
Postal code
Phone
+98 83 3826 4513
Fax
Email
vfarnia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Psychiatrist
Other areas of specialty/work
Street address
Farabi Hospital, Isar square
City
Kermanshah
Postal code
Phone
+98 83 3826 4513
Fax
Email
vfarnia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical
Full name of responsible person
Safora Salemi
Position
Pychologist
Other areas of specialty/work
Street address
Faculty of Social Science, Opp to Ayatollah Taleghani Hospital, Shahid Beheshti Blvd,Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3821 1001
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)