Clinical trial of the effect of curcuminoids supplementation compared with the placebo on mental health parameters and metabolic profiles in methadone maintenance treatment patients
The aim of this study is to determine the effects of curcuminoids supplementation on mental health parameters and metabolic profiles in methadone maintenance treatment patients
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 Gholabchi Clinic affiliated to Kashan University of Medical Sciences, 90 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. 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 60 years will be included in this study. Exclusion criteria: Unwillingness to cooperate.
Intervention groups
Intervention group: capsule contains 80 mg curcuminoids (Zahravi, Tabriz, Iran), daily, for 12 weeks orally. Control group: curcuminoids placebos capsule (Barij essence, Kashan, Iran), daily, for 12 weeks orally.
Main outcome variables
Depression; anxiety; sleep quality (primary outcome) and fasting plasma glucose; Insulin; triglycerides; total cholesterol; HDL; Hs-CRP; total antioxidant; glutathione; malondialdehyde (secondary outcome).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170420033551N8
Registration date:2019-08-18, 1398/05/27
Registration timing:retrospective
Last update:2019-08-18, 1398/05/27
Update count:0
Registration date
2019-08-18, 1398/05/27
Registrant information
Name
Amir Ghaderi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 771 7435
Email address
ghaderi-am@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-05, 1398/04/14
Expected recruitment end date
2019-08-05, 1398/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of curcuminoids supplementation compared with the placebo on mental health parameters and metabolic profiles in methadone maintenance treatment patients
Public title
Effect of curcuminoids supplementation in treatment of methadone maintenance treatment patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under methadone maintenance treatment
Individuals aged 18 to 70 years
Exclusion criteria:
Unwillingness to cooperate
Suicide attempts within the past 12 months or either suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician
Current opioid, alcohol or sedative physical dependence or cocaine dependence
Major cardiovascular disorder
Present or recent use (within 2 weeks) of over-the-counter or prescription drug that would be expected to have major interaction with curcuminoid
Metabolic diseases
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
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 in the same packaging at the Barij Essence pharmaceutical company. 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8814187159
Approval date
2019-06-30, 1398/04/09
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.036
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