- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03206411
Assessment of Severity and Outcome of Addicted Cases.
June 29, 2017 updated by: Sarah Abdelsamee Mohammed Ali, Assiut University
Assessment of Severity and Outcome of Addicted Cases Admitted to Neurology and Psychiatry Hospital in Assiut University.
- Addiction to drugs and alcohol is increasingly becoming a worldwide trend that is prevalent in both rich and poor countries . Substance abuse shows a significant warming to the health, social and economic build of families, communities and nations. Extent of worldwide psychoactive substance use is estimated at 2 billion alcohol users and 185 million drug users .
- Substance abuse (including alcohol and drugs) is an important risk factor for poor health globally due to their intoxicating effects or their toxic effects on organs and tissues that lead to the development of diseases, injuries and other health conditions
- Drug abuse is associated with the increased risk of cardiovascular diseases. A study on the need for hospitalization in approximately 4800 drug users found that 223 of these were admitted to hospital due to cardiovascular diseases .
- The majority of abused substances or their metabolites are excreted through the kidneys and renal complications of drug abuse are very common .The involvement of the kidney due to drug abuse is either attributed to their elimination through the kidney, or a direct nephrotoxic effect. The damage may be acute and reversible, or chronic and can leads to end stage renal failure .
- Addiction is responsible for different types of liver diseases including fatty liver, hepatitis and liver failure. . Intravenous drug addiction by sharing of contaminated needle is very important risk factor for the development of liver diseases, particularly hepatitis B and hepatitis C. Globally, 90% of new hepatitis C infections are attributed to drug injection . In the long run, substance abuse has negative effects on sexual functions and leads to the onset of sexual disorders. .
- Long term use of alcohol was reported to inhibit of hypothalamic-pituitary-adrenal axis and reduces the release of gonadotropins from the pituitary . Morphine administration suppresses LH release and reduces the levels of testosterone, which affects testicular function.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- Assiut University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who are addicted for at least one year.
Description
Inclusion Criteria:
- Patients who are addicted for at least one year.
Exclusion Criteria:
- Patients who are addicted for less than one year.
- Patients with history of previous renal impairment
- Patients with history of hepatitis B, C or HIV infection
- Patients with history of autoimmune disease.
- Patients with history of heart disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sex Hormones Profile
Time Frame: 1 day
|
Measure the changes in the Sex Hormones (LH , FSH and Testosterone) due to drug addiction in different people.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liver Function tests.
Time Frame: 1 day
|
Measure the changes in the liver enzymes (AST,ALT and ALP) due to drug addiction in different people.
|
1 day
|
|
Renal Functions tests.
Time Frame: 1 day
|
Measure the changes in the renal function due to drug addiction in different people.
|
1 day
|
|
ECG
Time Frame: 1 day
|
Record the changes in the Electrocradiogram due to addiction
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2016
Primary Completion (ANTICIPATED)
November 30, 2017
Study Completion (ANTICIPATED)
November 30, 2018
Study Registration Dates
First Submitted
June 28, 2017
First Submitted That Met QC Criteria
June 29, 2017
First Posted (ACTUAL)
July 2, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 29, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Addiction
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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