Protocol summary
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Study aim
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Objective: The aim of study is to evaluate the efficacy of quetiapine in treating methamphetamine dependency.
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Design
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In this research, 60 eligible patients with methamphetamine dependency diagnosis according to DSM-IV criteria are enrolled and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
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Settings and conduct
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60 eligible patients with methamphetamine dependency diagnosis referred to Gholabchi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Aged 18–65 years History of MA and opioid co-abuse in the past year, currently undergoing methadone maintenance treatment, seeking treatment for MA abuse and evaluated by the drug abuse section of the Structured Clinical Interview for DSM-IV and Exclusion Criteria: Suicide attempts within the past 6 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician, current alcohol or sedative physical dependence or cocaine dependence, major cardiovascular disturbance and metabolic diseases (e.g., neurological diseases and diabetes).
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Intervention groups
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The first group will receive quetiapine 100 mg daily for 8 weeks. The second group will receive placebo for 8 weeks.
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Main outcome variables
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Anxiety, depression, sleep quality, craving, withdrawal and negative urine test for methamphetamine (primary outcomes) and cognitive functions (secondary outcome).
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171106037290N1
Registration date:
2017-11-25, 1396/09/04
Registration timing:
retrospective
Last update:
2019-09-24, 1398/07/02
Update count:
1
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Registration date
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2017-11-25, 1396/09/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-10-17, 1396/07/25
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Expected recruitment end date
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2017-11-16, 1396/08/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Survey effect of quetiapine on methamphetamine abuse in patients Methadone Maintenance Treatment
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Public title
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Efficacy of quetiapine in methamphetamine dependency
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Aged 18–65 years
History of MA and opioid co-abuse in the past year
Currently undergoing methadone maintenance treatment
Seeking treatment for MA abuse
Evaluated by the drug abuse section of the Structured Clinical Interview for DSM-IV
Exclusion criteria:
Suicide attempts within the past 6 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician
Current alcohol or sedative physical dependence or cocaine dependence
Major cardiovascular disturbance
Metabolic diseases (e.g., neurological diseases and diabetes).
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random assignment will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-12, 1396/07/20
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Ethics committee reference number
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IR.KAUMS.REC.1396.54
Health conditions studied
1
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Description of health condition studied
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Methamphetamine dependence
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ICD-10 code
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F15
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ICD-10 code description
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Mental and behavioural disorders due to use of other stimulants, including caffeine
Primary outcomes
1
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Description
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Negative urine test for methamphetamine
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Timepoint
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Once every fifteen days
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Method of measurement
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methamphetamine urine test
2
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Description
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Depression
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Beck Depression Inventory (BDI)
3
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Description
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Anxiety
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Beck Anxiety Inventory (BAI)
4
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Description
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Sleep quality
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Pittsburgh Sleep Quality Index (PSQI)
5
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Description
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Craving
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Desire for Drug Questionnaire (DDQ craving)
6
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Description
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Withdrawal
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Amphetamine Withdrawal Questionnaire (AWQ)
Secondary outcomes
1
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Description
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Risky Decision Making
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Iowa Gambling Task (IGT)
2
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Description
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Memory
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Wechsler Logic Memory
3
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Description
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Verba Fluency
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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FAS task
4
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Description
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Speed Processing
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Digit Symbol and Trial Making Test (TMT)
Intervention groups
1
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Description
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Intervention group: Quetiapine 100 mg daily for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo for 8 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Vice chancellor for research, Kashan University of Medical Sciences
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available