1- Comparison of methadone consumption in the intervention and control groups
2- Comparison of recurrence of opioid use in methadone patients in intervention and control groups
3- Comparison of severity of addiction in methadone patients in intervention group and control group
4- Comparison of desire for consumption in patients in methadone group in intervention and control groups
5- Comparison of the observed side effects of methadone in the intervention and control groups
Design
A randomized, triple-blind, placebo-controlled clinical trial
Settings and conduct
MMT clinics. Evaluation at 0,4,10 and 14 weeks with Addiction Severity Index (ASI), Donepedzil Complications, Craving Visual Analogue
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1. Opioid use disorder according to diagnostic criteria with a specifier on DSM-5 agonist therapy
2. Age range from 18 to 55 years
3. Lack of Intellectual Disability Based on a Researcher's Interview as well as Minimum Fifth Level Education
4. Methadone at any dose (at least 20 mg) that has been stable for at least two months
Exclusion Criteria
1. Severe sensitivity to Donepezil
2. Patients taking Antidepressants, Carbamazepine, Dexamethasone, phenobarbital, Phenytoin, Rifampin, Clonidine, Succinylcholine and Betanecol
3. History of Donepezil in the past three months
4- Heart disease based on history and history of hospitalization for cardiac causes
5.Pregnancy and lactation
6. Any major psychiatric disorder according to the researcher's interview except smoking
7.-Using any kind of psychotherapy
Intervention groups
Intervention group will receive 5 mg of Donepezil capsule from day 1 to 28th day of intervention and will receive 10 mg of Donepezil capsule from day 29 after evaluation of mentioned cases until completion of study.
Main outcome variables
Opioids Craving, Methadone intake
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191217045766N1
Registration date:2021-11-24, 1400/09/03
Registration timing:prospective
Last update:2021-11-24, 1400/09/03
Update count:0
Registration date
2021-11-24, 1400/09/03
Registrant information
Name
Modabber Arasteh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3328 8188
Email address
modabber.arasteh@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-16, 1400/09/25
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Donepezil on the Methadone Consumption in Methadone Maintenance
Public title
Evaluation of the Effect of Donepezil on the Methadone Consumption
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All opioid dependent patients on Methadone agonist therapy in the age range of 18 to 55 years
At least fifth grade elementary education
Exclusion criteria:
Intellectual Disability
Use if Anti Depressant, Carbamazepin, Dexamethasone, Phenobarbital, Phenytoin, Rifampin, Clonidine, Sox, Betanecol
Use of Donepezil during 3 months ago
CAD
Pregnancy and Lactation
major psychiatric disorder
Use of Psychotherapy
Sever sensitivity to Donepezil
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, physicians, and analysts are unaware of who is receiving what medication. Therefore, the study is performed in a triple blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic commitment of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran Blv
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.MUK.REC.1398.307
Health conditions studied
1
Description of health condition studied
amount of Methadon use
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
amount of Methadon use
Timepoint
at the beginning of the study,weeks of 4, 10 and 14
Method of measurement
patients report
2
Description
craving for Methadon
Timepoint
at the beginning of the study,weeks of 4, 10 and 14
Method of measurement
HALIKAS Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Dopezil Sobhan Pharmaceutical Company Start with 5 mg oral tablets once a day for 4 weeks and then 10 mg tablets once a day until the end of week 14
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods hospital
Full name of responsible person
Razie Safari
Street address
Shohadaie Niruie Entezami Blv, Pasdaran Blv
City
Sanandaj
Province
Kurdistan
Postal code
6617713141
Phone
+98 87 3366 0026
Email
raziesafari68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical sciences
Full name of responsible person
Afshin Maleki
Street address
Pasdaran Blv
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3322 9494
Email
info@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?