Protocol summary

Summary
Summary With the goal of evaluation of the effect of Riluzole in the treatment of methamphetamine dependency, 40 patients are investigated in the present study. All patients only have Methamphetamine consumption in their recent addiction history. 20 patients are treated with placebo and non-medication (psychological) interventions and the other 20 individuals, in addition to non-medication (psychological) interventions, consume Riluzole. The duration of therapy is 3 months and the dosage of Riluzole is twice per day. In both groups, in spite of drug intervention and visit by physicians, patients refer to the center twice a week and take part in personal behavioral psychocognitive meetings with the modified matrix method. Matrix therapy is a non-medication (psychological) therapy method that based on the planned sessions issues like individual psychotherapy and family counseling is covered. In this study, patients take part in matrix meetings twice a week. The study is a clinical trial and a human sampling method that will be conducted at university addiction’s therapy center in the city of Yazd. In this study, patients with methamphetamine dependency will be randomly divided in two groups of oral Raluzole or placebo according to diagnostic DSM-IV-TR criteria. This is a double blind study in which except information committee personnel (analysts) all other groups including patients, therapists, and also researchers do not know anything about the quality of patients’ layout in different groups. Consequences are based on adherence to therapeutic regimen including: Percentage of physician visit and counseling that patient participate to all planned sessions, ratio of negative urinary sample results for Methamphetamine, Morphine, Cannabis and benzodiazepines that take place twice a week, addiction severity measured by addiction severity index (ASI), level of Methamphetamine withdrawal, and depression measured by Hamilton depression 17-items questionnaire (Hamilton Depression rating Scale). Inclusion criteria: Dependence to Methamphetamine according to DSM-IV criteria, consent and commitment for treatment cooperation, age above 18 and under 65. Exclusion criteria: Past history of sensitivity to Riluzole , past history of structural or functional liver disease or abnormal liver function tests (Ast, Alt) , 5-fold increase in liver enzymes test (Ast,Alt) or jaundice. Inclusion and exclusion criteria are evaluated based on the following methods: 1. Examination by the physician of the center. 2. Interview by the clinical psychiatrist of the center. 3. Performing required clinical laboratory tests and electrocardiography.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016012826168N1
Registration date: 2016-05-01, 1395/02/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-01, 1395/02/12
Registrant information
Name
Mohammadhadi Farahzadi
Name of organization / entity
Neuroscience Department School of Advanced Technologies in Medicine, Tehran University of Medical Sc
Country
Iran (Islamic Republic of)
Phone
+98 35 3524 8063
Email address
mh-farahzadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical Science
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of Riluzole compared with placebo in the treatment of Methamphetamine dependence: A randomized, double-blind, placebo-controlled trial
Public title
Evaluation of efficacy of Riluzole in the treatment of Methamphetamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Dependence to Methamphetamine according to DSM-IV criteria, consent and commitment for treatment cooperation, age above 18 and under 65. Exclusion criteria: Past history of sensitivity to Riluzole؛ past history of structural or functional liver disease or abnormal liver function tests (Ast, Alt). 5fold increase in liver enzymes test (Ast,Alt) or jaundice؛ abnormal renal function tests at the beginning of the study؛ interstitial lung disease or hypersensitive pneumonitis؛ neutropenia؛ pregnancy or lactation؛ developing psychiatric disorders or previous neurologic disorders like psychosis؛ bipolar disorders؛ major depression, tic disorders؛ Tourette's syndrome or any psychiatric disorders that need medical therapy or makes dependency to addiction therapy complicated; developing significant clinical cardiovascular disorders؛ physical exam or electrocardiography؛ family history of disability or premature cardiovascular mortality in first degree relatives؛ past history of severe untreated physical disabilities؛ abnormal vital signs.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences; Tehran; Iran
City
Tehran
Postal code
1417575694
Approval date
2016-01-10, 1394/10/20
Ethics committee reference number
IR.Tums.REC.1394.94-2-87-28567-181124

Health conditions studied

1

Description of health condition studied
Psychoactive substance use
ICD-10 code
F10, F11,
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use

Primary outcomes

1

Description
Adherence to treatment
Timepoint
Once a week
Method of measurement
Refer the patient to receive the drug(questionnaire)

2

Description
The proportion of negative urine test results
Timepoint
Once a week
Method of measurement
urine test

3

Description
Depression
Timepoint
Beginning and end of treatment
Method of measurement
Hamilton Depression Rating Scale

4

Description
Craving for methamphetamine
Timepoint
Monthly
Method of measurement
questionnaire

5

Description
Addiction Severity
Timepoint
Monthly
Method of measurement
ASI: Addiction Severity Index

6

Description
Methamphetamine dependence
Timepoint
Monthly
Method of measurement
ASI: Addiction Severity Index Questionnaire

Secondary outcomes

1

Description
Clinical examination of the pulse, and blood pressure
Timepoint
On admission and then weekly
Method of measurement
Clinical examination

2

Description
Riluzole side effects
Timepoint
Weekly
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: 20 patients are treated with Riluzole. The duration of therapy is 3 months and the dosage of Riluzole is twice per day.
Category
Treatment - Drugs

2

Description
Control group: 20 patients are treated with placebo. The duration of therapy is 3 months and the dosage of placebo is twice per day.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Iman Addiction Treatment Center
Full name of responsible person
Mohammadhadi Farahzadi
Street address
Addiction Treatment Center; Edalat Square; Azadshahr; Yazd; Iran
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Street address
Tehran University of Medical Sciences; Tehran; Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Advanced Technologies in Medicine, Tehran University of Medical Sciences Tehran
Full name of responsible person
Mohammadhadi Farahzadi
Position
Addiction studies PhD Assistant
Other areas of specialty/work
Street address
Addiction Treatment Center; Edalat square; Azadshahr; Yazd; Iran
City
Yazd
Postal code
Phone
+98 35 3722 8264
Fax
+98 35 3722 8264
Email
Mh-farahzadi@razi.tums.ac.ir; Dr.farahzadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Advanced Technologies in Medicine, Tehran University of Medical Sciences Tehran
Full name of responsible person
Mohammadhadi Farahzadi
Position
Addiction studies PhD Assistant
Other areas of specialty/work
Street address
Addiction Treatment Center; Edalat square; Azadshahr; Yazd; Iran
City
Yazd
Postal code
Phone
+98 35 3722 8264
Fax
+98 35 3722 8264
Email
Mh-farahzadi@razi.tums.ac.ir; Dr.farahzadi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Advanced Technologies in Medicine, Tehran University of Medical Sciences Tehran
Full name of responsible person
Mohammadhadi Farahzadi
Position
Addiction studies PhD Assistant
Other areas of specialty/work
Street address
Negin Shargh Apartment complex; Shargh Alley; Jomhoori Boulevard; Yazd; Iran
City
ٰYazd
Postal code
8917958143
Phone
+98 35248063
Fax
+98 37228264
Email
Mh-farahzadi@razi.tums.ac.ir؛ Dr.farahzadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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