Protocol summary
-
Study aim
-
The aim of this study is to determine the effects of N-acetylcysteine supplementation on psychological symptoms, oxidative stress, and inflammatory biomarkers in patients under methadone maintenance treatment
-
Design
-
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial.
-
Settings and conduct
-
Population and sample size: among patients under methadone maintenance treatment referred to Sultan Mir Ahmad Clinic affiliated to Kashan University of Medical Sciences, 70 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. Time of intervention: 12 weeks.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Patients on methadone maintenance treatment and aged 18 to 50 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
-
Intervention groups
-
Intervention: Patients will be assigned to receive either N-acetylcysteine (n=30) or placebo (n=30).
-
Main outcome variables
-
Depression; anxiety; sleep quality (primary outcome) and fasting plasma glucose; Insulin; triglycerides; total cholesterol; HDL; Hs-CRP; total antioxidant; glutathione; and malondialdehyde (secondary outcome).
General information
-
Reason for update
-
The updating process was done before publishing the paper to correct the registration information.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20170420033551N10
Registration date:
2020-09-19, 1399/06/29
Registration timing:
prospective
Last update:
2022-03-13, 1400/12/22
Update count:
1
-
Registration date
-
2020-09-19, 1399/06/29
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-09-20, 1399/06/30
-
Expected recruitment end date
-
2020-10-21, 1399/07/30
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effect of N-acetylcysteine supplementation on psychological symptoms, oxidative stress, and inflammatory biomarkers in patients under methadone maintenance treatment
-
Public title
-
Effect of N-acetylcysteine supplementation in treatment of methadone maintenance treatment patients
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients under methadone maintenance treatment
Age of 18 to 50 years old
Evaluated by the drug abuse section of the Structured Clinical Interview for DSM‐IV
Exclusion criteria:
Unwillingness to cooperate
Consumption of antioxidant, and anti-inflammatory supplements during the last 3 months
High blood pressure
Hypothyroidism or hyperthyroidism
Pregnant women
-
Age
-
From 18 years old to 50 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements. Supplements and placebos are only the code is written on the packages. Patients and researcher do not know the type of intervention and after analyzing the data, packet codes are decoded.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-05-19, 1399/02/30
-
Ethics committee reference number
-
IR.KAUMS.MEDNT.REC.1399.017
Health conditions studied
1
-
Description of health condition studied
-
Addiction
-
ICD-10 code
-
F19
-
ICD-10 code description
-
Other psychoactive substance related disorders
Primary outcomes
1
-
Description
-
Depression
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Beck Depression Inventory (BDI)
2
-
Description
-
Anxiety
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Beck Anxiety Inventory (BAI)
3
-
Description
-
Sleep quality
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
1
-
Description
-
Fasting plasma glucose
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
2
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Elisa kit
3
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
4
-
Description
-
Total cholesterol
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
5
-
Description
-
HDL
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
6
-
Description
-
Hs-CRP
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Elisa kit
7
-
Description
-
Total antioxidant
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
8
-
Description
-
Glutathione
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
9
-
Description
-
Malondialdehyde
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
10
-
Description
-
Malondialdehyde
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
Intervention groups
1
-
Description
-
Intervention group: tablet of N-acetylcysteine, 600 mg (Ave sina, Tehran, Iran), four oral tablet for 12 weeks.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: placebo tablet (Ave sina, Tehran, Iran), four oral tablet for 12 weeks.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Kashan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available