The effects of spirulina (Arthrospira platensis) supplementation compared to placebo on craving, mental health, sexual and cognitive function in opioid patients under methadone maintenance treatment
Determining the supplemental effect of spirulina on craving, mental health, sexual and cognitive function in opioid patients under methadone maintenance treatment.
Design
A randomized clinical trial with the control group, with parallel groups, double-blind, phase 3 on 50 patients, randomization by Permuted block randomization method
Settings and conduct
Place of study: addiction treatment centers affiliated with Kashan University of Medical Sciences; Study population: Opioid patients under methadone treatment; blinding: double-blind block; Blinding method: Capsules and placebos are placed in separate vials with code 1 and 2.
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent and willingness to participate in research; positive methadone urine test; Using methadone for at least one year; being married; age range 30-50 years. Exclusion criterion: Suffering from chronic physical diseases including phenyl ketonuria, autoimmune diseases, AIDS, hepatitis, liver and kidney disorders, cardiovascular disorders, etc. at the time of entering the treatment
The effects of spirulina (Arthrospira platensis) supplementation compared to placebo on craving, mental health, sexual and cognitive function in opioid patients under methadone maintenance treatment
Public title
Complementary effect of spirulina in the treatment of opioid patients under methadone maintenance treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent and informed willingness to participate in research
Positive methadone urine test
Using methadone for at least one year
Married men in the age range of 30-50 years
Exclusion criteria:
Suffering from chronic physical diseases including phenyl ketonuria, autoimmune diseases, AIDS, hepatitis, liver and kidney disorders, cardiovascular disorders, etc. at the time of entering the treatment
Age
From 30 years old to 50 years old
Gender
Male
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
First, the spirulina group will be coded with the letter A and the placebo group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists, randomization list will be prepared by selecting a sample size of 50 (two groups of 25) and permuted block randomization method (block size=4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups, A or B. For example, suppose that in the first block, the permutation order is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B, and the same will continue until the last sample (25th person).
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind, and after selecting the samples, none of the sampled people will know about randomization and the allocation process to groups. Patients enter the study based on the randomization list. This study will try to use the placebo similar to the capsules in terms of color, size, and the number of pills for 12 weeks of intervention. The composition of the placebo in the present study is paraffin. In addition, to keeping blind the presenters and patients, pills and placebos are placed in separate vials named with codes 1 and 2.
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
Kashan University of Medical Sciences, Qutb Rawandi Blvd
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2023-10-29, 1402/08/07
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.186
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
Mental health
Timepoint
At the beginning of the study and the twelfth week of the study
Method of measurement
Depression‚ Anxiety‚ Stress Scale (DASS21)
2
Description
Sexual function
Timepoint
At the beginning of the study and the twelfth week of the study
Method of measurement
International Index of Erectile Function (IIEF)
Secondary outcomes
1
Description
Craving
Timepoint
At the beginning of the study and the twelfth week of the study
Method of measurement
Desire for Drug Questionnaire (DDQ craving)
2
Description
Cognitive function
Timepoint
At the beginning of the study and the twelfth week of the study
Method of measurement
Cattell–Horn–Carroll (CHC) approach
Intervention groups
1
Description
Intervention group: The patient group will be given spirulina supplement and they will consume it for 3 months, the daily dosage is two 500 mg capsules.
Category
Treatment - Drugs
2
Description
Control group: A placebo with the same appearance as spirulina capsules is prescribed for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Substance Abuse Center, Mehrparvar Clinic
Full name of responsible person
Amir Ghaderi
Street address
Mehrparvar clinic; Mehrgan Alley; 200 meters above the fire station; Mehr Housing
City
Kashan
Province
Isfehan
Postal code
8718317657
Phone
+98 31 5534 9472
Email
gaderiam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamali Hamidi
Street address
Kashan University of Medical Sciences; Qutb Rawandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
hamiidi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fatemeh Mehrzad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Kargarnejad Hospital, Ghotbe Ravandi Boulevard
City
kashan
Province
Isfehan
Postal code
87159 88111
Phone
+98 31 3457 4191
Email
mehrzad.fateme60@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Amir Ghaderi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Addiction studies
Street address
Faculty of Medicine; Kashan University of Medical Sciences; Qutb Rawandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
gaderiam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Freshteh Haerifar
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Faculty of Medicine; Kashan University of Medical Sciences; Qutb Rawandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3457 4191
Email
Fh.haerifar@gmail.com
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