Aim of this study will be assessment the effectiveness of pregabalin on sleep quality in patients under methadone maintenance treatment. This study will be a randomize double blind clinical trial. Inclusion criteria will include history of heroin dependency and patients under methadone maintenance treatment .Exclusion criteria will include age under 18 year and older than 75; starting methadone maintenance treatment less than 6 month; patients with major depressive disorder or psychosis based on psychiatrist visit and absence of any problem in sleep( PSQ sleep quality questionnaire score less than 5).population of this study will include patients under methadone maintenance treatment in methadone maintenance treatment clinics in Bojnurd, North eastern of IRAN. Sample size will be 140 participants. we will use computed generation random allocation for randomization .participants randomly will divide two groups and take either 75 mg day pregabalin before sleep or placebo for 8 week. Participants will accept 3 stage of assessment in 8 weeks (in the beginning, 4 week and 8 week after beginning) and then two groups will compare in term of change in sleep quality scores. We will use standard drug side effects checklist for assessment of possible side effects. This checklist will complete by therapists (physician) weekly for 8 week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021121045N1
Registration date:2015-11-12, 1394/08/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-11-12, 1394/08/21
Registrant information
Name
Seyed kaveh Hojjat
Name of organization / entity
North khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3223 0783
Email address
kaveh.hojjat@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
North khorasan University of Medical Sciences,Addiction and Behavioral Sciences Research Center
Expected recruitment start date
2016-01-10, 1394/10/20
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Pregabalin on Sleep Quality in Patients Receiving Methadone Maintenance Treatment: A Randomized double blind Clinical Trial
Public title
Effectiveness of Pregabalin on Sleep Quality in Patients Receiving Methadone Maintenance Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: History of heroin dependency; patients under methadone maintenance treatment
Exclusion criteria: Age under 18 year and older than 75; starting methadone maintenance treatment less than 6 month; PSQ sleep quality questionnaire score less than 5; patients with severe sleep disorder who need special treatment or major depressive disorder or psychosis based on psychiatrist visit; Participants with methadone maintenance dose lower than 60 mg/day or higher than 120 mg/day; Participant with using sedative- hypnotic drugs or heroin or methamphetamine during 8 week intervention
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
North khorasan University of Medical Sciences,Ethics committee
Street address
7 Plaque,Mohaghar Street,South Shariati Street,Bojnurd ,Deputy of Research,Ethics committee office
City
Bojnurd
Postal code
Approval date
2015-06-07, 1394/03/17
Ethics committee reference number
ir.nkums.rec.1394.3
Health conditions studied
1
Description of health condition studied
SUBSTANCE DEPENDENCY
ICD-10 code
F10
ICD-10 code description
A cluster of behavioural, cognitive, and physiological phenomena that develop after repeated substance use and that typically include a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences
Primary outcomes
1
Description
sleep quality
Timepoint
before intervention,week 4,week 8
Method of measurement
Pittsburgh sleep quality questionaire
Secondary outcomes
1
Description
drug side effects
Timepoint
week 1-8,weekly
Method of measurement
standard side effects checklist
Intervention groups
1
Description
intervention group will receive one capsule (75 milligram) before sleep for 8 week.
Category
Treatment - Drugs
2
Description
control group will receive one capsule same shape and color with pregabalin before sleep for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
SABA methadone maintenance treatment center
Full name of responsible person
Dr seyed kaveh hojjat
Street address
17 Plaque,Mehregan Building ,Ordibehesht Street,South Shariati Street,Bojnurd ,Deputy of Research
City
Bojnurd
2
Recruitment center
Name of recruitment center
bojnurd governmental methadone maintenance treatment center
Full name of responsible person
dr hamid firozeh
Street address
9 PLAQUE,West Taleghani Street
City
Bojnurd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
North khorasan University of Medical Sciences,Deputy of Research
Full name of responsible person
Dr Alireza Golshan
Street address
7 Plaque,Mohaghar Street,South Shariati Street,Bojnurd ,Deputy of Research
City
Bojnurd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
North khorasan University of Medical Sciences,Deputy of Research
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
North khorasan university of MedicalSciences,Addiction and Behavioral Sciences Research Center
Full name of responsible person
Dr seyed kaveh Hojjat
Position
Assistant professor of psychiatry,North khorasan University of Medical Sciences,Head of Addiction an
Other areas of specialty/work
Street address
7 Plaque,Mohaghar Street,South Shariati Street,Bojnurd, IRAN,Deputy of Research,Addiction and Behavioral Sciences Research Center
City
Bojnurd
Postal code
Phone
+98 582211009
Fax
Email
k.Hojjat@Nkums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North khorasan University of Medical Sciences, Addiction and behavioral sciences research center
Full name of responsible person
Dr Seyed kaveh Hojjat
Position
Assistant professor of psychiatry,Head of Addiction and behavioral sciences research center
Other areas of specialty/work
Street address
7 Plaque,Mohaghar Street,South Shariati Street,Bojnurd ,Deputy of Research
City
Bojnurd
Postal code
Phone
+98 582211009
Fax
Email
K.Hojjat@nkums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr seyed kaveh Hojjat
Position
Other areas of specialty/work
Street address
7 Plaque,Mohaghar Street,South Shariati Street,Bojnurd ,Deputy of Research
City
Bojnurd
Postal code
Phone
00
Fax
Email
K.Hojjat@nkums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)