- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00687089
Examination of Cognitive Function in Patients Treated With Subutex
Examination of Cognitive Function, Weight, Sexual Function in Patients Receiving Treatment With Subutex at 3 Months Without Using Opiates
People who addicted to Heroin and other opiates suffer from a disease with approved genetic basis. It causes to a behavioral response as searching and using those drugs even though they know it causes severe damages as physiological, familiar and legal affairs.
The popular treatment's goal is to "clean" the people from any drug. In a medical and pharmacological point of view there is no sense in this approach for all people. This point of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment.
The hypothesis of this research is that people using Buprenorphine have difficulties in gaining weight, in sexual and cognitive function (according to subjects' reports)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
People who addicted to Heroin and other opiates suffer from a disease with approved genetic basis. It causes to a behavioral response as searching and using those drugs even though they know it causes severe damages as physiological, familiar and legal affairs.
The popular treatment's goal is to "clean" the people from any drug. In a medical and pharmacological point of view there is no sense in this approach for all people. This point of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment.
The hypothesis of this research is that people using Buprenorphine have difficulties in gaining weight, in sexual and cognitive function (according to subjects' reports) We examine people who stopped opiates and began Buprenorphine. Every participant in the study will have two visits: the first one before receiving Buprenorphine and the second one after 3 months of receiving Buprenorphine.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- People who suffer from addiction problems (opiates)
- People who willing to to start Buprenorphine treatment
- People who willing to cooperate with study tests and questionnaires
- People aged 18 to 70
Exclusion Criteria:
- People who suffer from any neurocognitive problems
- People who suffer from mental illnesses
- People who are having legal guardian
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Subutex group
People who used opiates and willing to start with subutex treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ASI quationarry, neurocognitive computerized tests, MMSE test, Sexual function questionnaire and satisfaction questionnaire
Time Frame: In 2 visits during the study
|
In 2 visits during the study
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Subutex-214CTIL
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