Comparing the effect of Trazodone and Quetiapine on recovery of sleep disturbances on patients who received methadone maintenance therapy
Design
Clinical trial study,phase 3,randomized,parallel groups,each group 35 patients was designed in the period of 2017-2018
Settings and conduct
Patients in Zakerian addiction treatment center (Babol University of Medical Sciences) due to substance use disorder undergo Methadone maintenance therapy and according to the Pittsburgh questionnaire they have sleep disturbance.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing Methadone maintanance treatment who received a total score of over 5 according to the PSQI questionnare, the substance used by the patient should not interfere with Quetiapine and Trazodone drugs.No-entrance criteria: Unwillingness to participate in the study; Having a previous illness that prohibits prescribing drugs.
Comparing the effect of Trazodone and Quetiapine on recovery of sleep disturbances on patients who received methadone maintenance therapy
Public title
Comparison of the effect of Quetiapine and Trazodone on sleep improvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing Methadone maintenance treatment, who received a total score of over 5 according to the PSQI questionnaire
The substance used by the individual does not interfere with Trazadone and Quetiapine drugs
Exclusion criteria:
Unwillingness to participate in the study
Having a previous illness that prohibits prescribing drugs
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method was performed using a random number table. First, numbers from 1 to 70 were randomly generated using SPSS software (statistical packages for social sciences) and top-down one among the numbers associated with Trazodone and Quetiapine.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Babol University of Medical sciences
Street address
Babol University of medical sciences, Ganjafrooz street
City
Babol
Province
Mazandaran
Postal code
45745-47176
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
MUBABOL.HRI.REC.1396.241
Health conditions studied
1
Description of health condition studied
Sleep disturbances
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnia]
Primary outcomes
1
Description
Sleep quality
Timepoint
End of one month after treatment begins
Method of measurement
Pittsburgh sleep quality index
Secondary outcomes
1
Description
General health
Timepoint
End of one month after treatment begins
Method of measurement
General health questionnaire
Intervention groups
1
Description
"Intervention group 1": In male patients with methadone treatment that has been associated with sleep disturbances during treatment with this drug, terazodone tablet from Tehran Chemie and Razak Pharmaceutical company at a dose of 25-100 mg, It is prescribed daily (evening) for one month.
Category
Treatment - Drugs
2
Description
"Intervention group 2": In male patients with methadone treatment that has been associated with sleep disturbances during treatment with this drug, Quetiapine tablet from Tehran Chemie and Bakhtar Bioshimi Pharmaceutical company at a dose of 25-200 mg, It is prescribed daily (evening) for one month.