Role of Attentional Bias Modification to Drug Related-Stimuli with and without Reinforcement and Punishment in Decreasing Related-Components with Addiction in Abstinent Drug Abusers
Determine the effect of two methods of attentional bias modification and attentional bias modification with reinforcement and punishment in reducing attentional bias, pre-attentional bias, craving and danger of relapse
Design
Statistical population: Abstinent drug users
Sample size: 60 participants
Clinical experiment with control group, with parallel group, one-side blinded, randomised
Settings and conduct
Ahvaz city
One-side blinded by dot-probe placebo
Participants/Inclusion and exclusion criteria
At least drug intake once in week at six months, to detoxify or not use any alternative preservative treatment, such as methadone or bupronorphine, to pass at least two weeks after the beginning of the abstinence period without relapse and not getting disturbed psychotic spectrum or other clinical disorders that disrupts the process of research
Intervention groups
Control group: Dot-probe placebo
Attentional bias modification group: Dot-probe for attentional bias modification
Attentional bias modification whit reinforcement and punishment: Dot-probe for attentional bias modification whit reinforcement and punishment
Main outcome variables
Reduce in attentional bias, pre-attentional bias, craving and relapse in experimental groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180628040267N1
Registration date:2018-07-28, 1397/05/06
Registration timing:retrospective
Last update:2018-07-28, 1397/05/06
Update count:0
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
Ali Nowrouzi
Name of organization / entity
Shahid Chamran University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 6911
Email address
a.nowrouzi.s@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-01, 1396/06/10
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2017-09-01, 1396/06/10
Actual recruitment end date
2017-11-21, 1396/08/30
Trial completion date
empty
Scientific title
Role of Attentional Bias Modification to Drug Related-Stimuli with and without Reinforcement and Punishment in Decreasing Related-Components with Addiction in Abstinent Drug Abusers
Public title
Role of Attentional Bias Modification in Addiction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Intake drug at least once per week in last six months
Detoxifying or not using any alternative preservative treatment such as methadone or buprenorphine
To pass at least two weeks from the beginning of abstinent period without relapse
Absence of psychotic spectrum disorders or other clinical disorders that may to be detrimental to the process of research
Exclusion criteria:
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individual simple randomization by random numbers table
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant blinding
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Chamran university of Ahvaz
Street address
Shahid Chamran university of Ahvaz, University square, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
7134776671
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
260
Health conditions studied
1
Description of health condition studied
Addiction
ICD-10 code
Z63.72
ICD-10 code description
Alcoholism and drug addiction in family
Primary outcomes
1
Description
Attentional bias
Timepoint
Days: 1, 4, 34
Method of measurement
Dot-probe task
2
Description
Pre-attentional bias
Timepoint
Days: 1, 4, 34
Method of measurement
Dot-probe task
3
Description
Craving
Timepoint
Days: 1, 4, 34
Method of measurement
Brief substance craving scale by Somoza
4
Description
Relapse
Timepoint
Day: 34
Method of measurement
One question
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Attentional bias modification by dot-probe task in 2 consecutive days that each time containing 10 pairs of words and 10 pairs of images, that each stimulus was repeated 4 times, in total 80 trials
Category
Treatment - Other
2
Description
Intervention group 2: Attentional bias modification with reinforcement and punishment by dot-probe task in 2 consecutive days that each time containing 10 pairs of words and 10 pairs of images, that each stimulus was repeated 4 times, in total 80 trials that correct answers were reinforced and wrong answers were punished.
Category
Treatment - Other
3
Description
Control group: Dot-probe task placebo in 2 consecutive days that each time containing 10 pairs of words and 10 pairs of images, that each stimulus was repeated 4 times, in total 80 trials and the design of the task was similar to the assessment phase
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran university of Ahvaz
Full name of responsible person
Ali Nowrouzi
Street address
Shahid Chamran university of Ahvaz, University square, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
7134776671
Phone
+98 71 3233 6911
Email
a.nowrouzi.s@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Chamran university of Ahvaz
Full name of responsible person
Ali Nowrouzi
Street address
Shahid Chamran university of Ahvaz, University square, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
7134776671
Phone
+98 61 3333 0012
Email
a.nowrouzi.s@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?