Objective: The aim of study is to evaluate the efficacy of quetiapine in treating methamphetamine dependency.
Design
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.
Settings and conduct
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. Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion Criteria are METH dependence; as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV; 18-50 years old and Exclusion Criteria are documented hypersensitivity to quetiapine; severe hepatic impairment; hypertension; seizure disorders and Suicide attempts within the past 12 months
Intervention groups
The first group will receive quetiapine 25 mg daily for 8 weeks. The second group will receive placebo for 8 weeks.
Main outcome variables
Methamphetamine withdrawal symptoms is evaluated with Amphetamine withdrawal questionnaire (AWQ) and Craving is evaluated with VAS and desire of drug questionnaire (DDQ) every fifteen days. Methamphetamine urine test also is done every fifteen days.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171106037290N1
Registration date:2017-11-25, 1396/09/04
Registration timing:registered_while_recruiting
Last update:2017-11-25, 1396/09/04
Update count:1
Registration date
2017-11-25, 1396/09/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 8856
Email address
javdan-na@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-17, 1396/07/25
Expected recruitment end date
2017-11-16, 1396/08/25
Actual recruitment start date
2017-11-22, 1396/09/01
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
empty
Scientific title
The Survey effect of quetiapine on methamphetamine abuse in patients Methadone Maintenance Treatment
Public title
Efficacy of quetiapine in methamphetamine dependency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria:18-65 years old; On Methadone maintenance treatment; METH dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV; Seeking treatment for METH use; At least weekly self-reported METH use during a preceding three month period.
Exclusion criteria:
Exclusion Criteria: Suicide attempts within the past 12 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician؛ Current opioid, alcohol or sedative physical dependence or cocaine dependence؛ Major cardiovascular disorder؛ present or recent use (within 2 weeks) of over-the-counter or prescription drug that would be expected to have major interaction with quetiapine؛ Metabolic diseases such as diabetes and neurological diseases such as epilepsy
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind (both patients and researchers) in your study are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2017-10-12, 1396/07/20
Ethics committee reference number
IR.KAUMS.REC.1396.54
Health conditions studied
1
Description of health condition studied
Methamphetamine dependence
ICD-10 code
F15
ICD-10 code description
Mental and behavioural disorders due to use of other stimulants, including caffeine
Primary outcomes
1
Description
Negative urine test for methamphetamine
Timepoint
Once every fifteen days
Method of measurement
methamphetamine urine test
Secondary outcomes
1
Description
Measure of desire for methamphetamine
Timepoint
Once every fifteen days
Method of measurement
by desire for drug questionnaire
2
Description
Evaluation of methamphetamine withdrawal symptoms
Timepoint
Once every fifteen days
Method of measurement
Methamphetamine Withdrawal Questionnaire
3
Description
Evaluation of cognitive function
Timepoint
Once every fifteen days
Method of measurement
Cognitive Function Questionnaire
Intervention groups
1
Description
Intervention group: Quetiapine 40 mg daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gholabchi Clinic
Full name of responsible person
Najmesadat Javdan
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
javdan-na@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 2999
Email
hamidi_gh@kaums.ac.ir
Grant name
Vice chancellor for research, Kashan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Najmesadat Javdan
Position
PHD Assistant in addiction studies
Latest degree
Master
Other areas of specialty/work
Addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
javdan-na@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Position
PhD in Pharmacology-Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Phone
+98 31 5557 9001
Email
banafsh-h@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Najmesadat Javdan
Position
PHD Assistant in addiction studies
Latest degree
Master
Other areas of specialty/work
Addiction
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
javdan-na@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available