Reducing drug cravings and improving brain function by phototherapy and brain rehabilitation
Design
This clinical trial has a control group with intersecting groups that is not corseted and individuals will be randomly divided into these 4 groups. This study will be performed in phase 3 on 84 patients and randomized software using random allocation software.
Settings and conduct
This study is a research in the field of addiction and will be conducted in opioid drug treatment centers. After obtaining the consent of the company in the research, the desired pre-tests will be performed, then the people will be randomly divided into 4 groups and phototherapy and cognitive rehabilitation interventions and the combined effect of these two therapeutic approaches will be performed. Then post-test evaluations will be performed and finally 2 months later they will be evaluated again to follow the treatment status.
Participants/Inclusion and exclusion criteria
In this study, people with acute psychiatric disorders or neurological disorders such as cerebral aneurysms, brain tumors, epilepsy, are not suitable for such therapeutic interventions and also from the entry of people with high blood pressure or pacemakers or substances The stimulus used is prevented.
Admission Requirements: Referrals to addiction treatment clinics that use opioid drugs. Also, the age requirement for participating in the research is 18 to 60 years.
Intervention groups
This research has 4 main groups.
One group will undergo cognitive rehabilitation treatment.
One group will receive phototherapy. This group also has a placebo subset.
The third group will receive both cognitive rehabilitation and phototherapy approaches.
The fourth group is the control group on which no treatment will be performed.
The combination effect of cognitive rehabilitation and phototherapy on craving and cognitive functions of the clients of drug addiction clinics
Public title
The effect of cognitive rehabilitation and phototherapy on craving and cognitive functions in opioid addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the consent to participate in research
Do not take psychiatric drugs
Having the power of individual recognition and cognition
Being 18 to 60 years old
No deprivation or poisoning of drugs or narcotics
Exclusion criteria:
Use of stimulants and hallucinogens
Female gender
Acute neurological disorders
Epilepsy, brain tumor, pacemaker, hypertension, visual and auditory impairment
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Karaj
Street address
Nu2/2, Ehsan Av, Satar khan bridge, Satar khan St.
City
tehran
Province
Tehran
Postal code
1454613431
Approval date
2020-10-11, 1399/07/20
Ethics committee reference number
ir.iau.k.rec.1399.054
Health conditions studied
1
Description of health condition studied
addiction
ICD-10 code
F11
ICD-10 code description
Opioid related disorders
Primary outcomes
1
Description
drug craving
Timepoint
This variable is measured before the phototherapy and brain rehabilitation intervention and after the interventions and 2 months later to follow the treatment status
Method of measurement
Instant and induced cravings and visual analog index tests
2
Description
brain functions
Timepoint
This variable is measured before the phototherapy and brain rehabilitation intervention and after the interventions and 2 months later to follow the treatment status
Method of measurement
Response inhibition is assessed with GO-NO-GO assessment software, risk-taking is assessed with Balloon Analogue Risk Task (BART) software, and emotion regulation is assessed by Panas positive and negative emotion testing.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group first undergoes 8 to 12 sessions of phototherapy and then undergoes 10 to 15 sessions of brain rehabilitation. Therapeutic sessions are twice a week. In phototherapy intervention, a low-power RJ laser device made by the German company RJ is used to stimulate the frontal and peripheral lobes. Stop signal and Captain log software are used in brain rehabilitation intervention.
Category
Rehabilitation
2
Description
Intervention group 2: The second group is first treated with 10 to 15 sessions of brain rehabilitation treatment and then with 8 to 12 sessions of phototherapy. Therapeutic sessions are held twice a week. In phototherapy intervention, a low power RJ laser device made by the German company RJ is used to optically stimulate the frontal and peripheral lobes. Stop signal and Captain log software are used in brain rehabilitation intervention.
Category
Rehabilitation
3
Description
The control group will not receive any treatment.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Nik Teb Abuse Treatment Center
Full name of responsible person
Sayena Hadadgar
Street address
N2/2 , Ehsan Av, Satar khn St.
City
tehran
Province
Tehran
Postal code
1454613431
Phone
+98 21 8824 6126
Email
hadad.phd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamed Sabet
Street address
N 2/2,Ehsan Av, Satar khan St.
City
karaj
Province
Alborz
Postal code
3149968111
Phone
+98 26 3425 9576
Email
h-sabet@kiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Karaj
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
Islamic Azad University
Full name of responsible person
Sayena Hadadgar
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
N 2/2, Ehsan Av. Satar khan St.
City
Tehran
Province
Tehran
Postal code
1454613431
Phone
+98 21 8824 6126
Email
hadad.phd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sayena Hadadgar
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
N 2/2, Ehsan Av, Satar khan St.
City
Tehran
Province
Tehran
Postal code
1454613431
Phone
+98 21 8824 6126
Email
hadad.phd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sayena Hadadgar
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
N 2/2, Ehsan Av, Satar khan St.
City
Tehran
Province
Tehran
Postal code
1454613431
Phone
+98 21 8824 6126
Email
hadad.phd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD