Comparison of the effect of pioglitazone and placebo on therapeutic efficacy and quality of life in methamphetamine dependent patients.
Design
parallel
Settings and conduct
100 patients between the age range of 20 to 50 due to their addiction to methamphetamine, are hospitalized in Beheshti medical and educational centre of zanjan and/or recourse to clinic of Beheshti medical and educational centre of zanjan, after considering the factors and causes of entry and exit from the study, they are divided into 2 groups randomly. Then, one group will be under treatment with common medicine for their addiction (Control) and for treating 2nd group (Interference) we add Pioglitazone (30mg) for 3 month. After that, during specific intervals the life quality and the rate of response to method are compared in pre and post examination. It is good to mention that, placebo is given to control group with the exact form, size and color of Pioglitazone. Also, quality of life is going to be evaluated by Nottingham's questionnaire and rate of response to the method is going to be evaluated by process of the illness during the study.
Participants/Inclusion and exclusion criteria
inclusion criteria: Methamphetamine dependent patients admitted to zanjan beheshti hospital in the age group of 20 to 50 years.
exclusion criteria: 1- chronic medical conditions include diabetes , severe liver disorder & severe heart disorder. 2- pioglitazone contraindications if any.
Intervention groups
Received pioglitazone tablet (30 mg per day)
Main outcome variables
Quality of life, treatment efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190427043389N1
Registration date:2019-10-27, 1398/08/05
Registration timing:registered_while_recruiting
Last update:2019-10-27, 1398/08/05
Update count:0
Registration date
2019-10-27, 1398/08/05
Registrant information
Name
Hamed Ghavimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 3635
Email address
ghavimih@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2020-01-10, 1398/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of co-administration of pioglitazone to methamphetamine addict patients therapy regimen on the quality of life and the treatment efficacy.
Public title
The effect of pioglitazone on reducing methamphetamine dependence.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Methamphetamine-dependent patients admitted to beheshti hospital in zanjan included in the study.
Methamphetamine-dependent patients referred to the clinic of beheshti training center of zanjan in the study.
The age range of patients is between 20 to 50 years.
Exclusion criteria:
chronic medical conditions include diabetes , severe liver disorder & severe heart disorder.
pioglitazone contraindications if any.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
the clinical trial will be planned in such a way that the participant and the clinical caregiver do not know which of the two control or test groups belongs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences