Objective: Comparative effect of zolpidem and lorazepam on the severity of insomnia in methadone maintenance patients
The study is randomized and double -blind (Failure to inform patients and researchers of the drug inside the envelopes).
Inclusion criteria: All addict patients treated with methadone and with severe insomnia
Exclusion criteria: Medical and psychiatric illness that causes sleep disorders are serious. Use other hypnotic drugs before or during the study. Change the dose of methadone
Study population: addicts treated with methadone with moderate to severe insomnia
Sample size: 60
Patients were randomly assigned to two treatment groups with lorazepam 2 mg and zolpidem 10 mg for the 2 - week period
The demographic data (ethnicity, gender, age, type of addiction, duration of addiction, narcotic type and duration of treatment) with Czech extracted list.
To assess the sleep quality of the insomnia severity index (ISI) used. ISI has a 5-point scale. Scores are between 0 and 28.0-7 insomnia is not clinically significant. 8 to 14 below clinical threshold. 15-21 The average clinical insomnia. 22-28 Severe insomnia.If the patient with severe to moderate, moderate to mild improvement and effective treatment can be defined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081021309N2
Registration date:2015-10-08, 1394/07/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-08, 1394/07/16
Registrant information
Name
Mohammad Zaman Kamkar
Name of organization / entity
Golestan Research Center of Psychiatry
Country
Iran (Islamic Republic of)
Phone
+98 17 3232 8051
Email address
dr.kamkar@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of zolpidem and lorazepam on the severity of insomnia in methadone maintenance patients
Public title
the effect of zolpidem and lorazepam on the severity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All addict patients treated with methadone and with severe insomnia
Exclusion criteria: Medical and psychiatric illness that causes sleep disorders are serious. Use other hypnotic drugs before or during the study. Change the dose of methadone
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences
City
Gorgan
Postal code
4934174515
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
IR.GOUMS.REC.1394.62
Health conditions studied
1
Description of health condition studied
severe insomnia
ICD-10 code
F40, F41,
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
Insomnia
Timepoint
at the begining of study
Method of measurement
ISI Insomnia Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Interventiom Group: 30 Paitions
Name of consumer: Zolpidem
Dosage: 10 mg
Time consumption: 2 weeks
Category
Treatment - Drugs
2
Description
Control Group: 30 Paitions
Name of consumer: Lorazepam
Dosage: 2 mg
Time consumption: 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan MMT( Methadone Maintenance Treatment)
Full name of responsible person
Dr Mohammad Zaman kamkar
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Golestan University of Medical Sciences
Full name of responsible person
Dr Masoud khoshnia
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Golestan 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
Golestan Research Center of Psychiatry
Full name of responsible person
Dr Mohammad Zaman Kamkar
Position
Director of Research Center of Psychiatry
Other areas of specialty/work
Street address
No:88, 10 Azar Streat, 5 Azar Streat, Research Center Department, Research Center of Psychiatry
City
Gorgan
Postal code
Phone
+98 17 3232 5581
Fax
+98 17 3232 5581
Email
Dr.kamkar@goums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan Research Center Psychiatry
Full name of responsible person
Dr Mohammad Zaman Kamkar
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
No:88, Research Center Department, 10 Azar Streat, 5 Azar Streat,
City
Gorgan
Postal code
Phone
+98 17 3232 5581
Fax
+98 17 3232 5581
Email
Dr.kamkar@goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan Research Center of Psychiatairy
Full name of responsible person
Dr Mohammad Zaman Kamkar
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
No:88, Research Center Department, 10 Azar Streat, 5 Azar
City
Gorgan
Postal code
Phone
+98 17 3232 5581
Fax
+98 17 3232 5581
Email
Dr.kamkar@goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)