The efficacy of venlafaxine in the treatment of depression, withdrawal symptoms, craving for methamphetamine compared with placebo (clinical trial with a control group)
Evaluation of the efficacy of venlafaxine in the treatment of depression, withdrawal symptoms, craving for methamphetamine compared to placebo (clinical trial with a control group)
Design
Clinical trial with control group
Settings and conduct
Farabi Hospital in Kermanshah
Participants/Inclusion and 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
Intervention groups
Intervention group: Intervention group: The group will receive venlafaxine treatment in two months.Daily drug intake will be one capsule that will receive a capsule of 20 mg in the first month and a 30 mg capsule in the second month.The capsules without the knowledge of the patient and the examiner will be given to patients with any drug-related code in a questionnaire elderly patient.The control group will receive placebo treatment in two months.Placebo capsules (lactose powder, gelatin solution, 5% and MCC) in terms of shape, size, color and smell are similar to capsules venlafaxine .
Main outcome variables
Depression, withdrawal signs, craving
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160717028967N8
Registration date:2018-06-30, 1397/04/09
Registration timing:prospective
Last update:2018-06-30, 1397/04/09
Update count:0
Registration date
2018-06-30, 1397/04/09
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
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of venlafaxine in the treatment of depression, withdrawal symptoms, craving for methamphetamine compared with placebo (clinical trial with a control group)
Public title
Compareing effects of venlafaxine and Placebo on depression, withdrawal symptoms, craving
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
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The medication and placebo are delivered to the patient without sticking the label. The doctor is also unaware of the type of drug used in each group. The color and smell of main drug and placebo are the same.
Placebo
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
Province
Kermanshah
Postal code
6719851115
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
kums.rec.1396.595
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
Depression
Timepoint
before intervention- 4 weeks later- 8 weeks later
Method of measurement
Depression Inventory
2
Description
Withdrawal symptoms
Timepoint
before intervention- 4 weeks later- 8 weeks later
Method of measurement
Inventory withdrawal symptoms
3
Description
Craving
Timepoint
before intervention- 4 weeks later- 8 weeks later
Method of measurement
Craving Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group will receive duloxetine treatment in two months
Category
Treatment - Drugs
2
Description
Control group: The control group will receive placebo treatment in two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Faezeh Tatari
Street address
Farabi Hospital, Isar square
City
Kermanshah
Province
Kermanshah
Postal code
6744590785
Phone
+98 83 3826 4513
Email
s_salemi85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3826 5413
Email
khamzehee@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Faezeh Tatari
Position
Psychiatrist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital, Isar square
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3826 4513
Email
tatari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Faezeh Tatari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital, Isar square
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 833826513
Email
s_salemi85@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Faezeh Tatari
Position
Psychiatrics
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital, Isar square
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3826 4513
Email
tatari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
I have no plans at this time
When the data will become available and for how long
I have no plans at this time
To whom data/document is available
I have no plans at this time
Under which criteria data/document could be used
I have no plans at this time
From where data/document is obtainable
I have no plans at this time
What processes are involved for a request to access data/document