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Assessment of Severity and Outcome of Addicted Cases.

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ClinicalTrials.gov Identifier: NCT03206411
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Sarah Abdelsamee Mohammed Ali, Assiut University

Brief Summary:
  • 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.

Condition or disease Intervention/treatment
Addiction, Substance Diagnostic Test: Renal and liver function tests , ECG , Sex Hormones Profile

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Assessment of Severity and Outcome of Addicted Cases Admitted to Neurology and Psychiatry Hospital in Assiut University.
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Renal and liver function tests , ECG , Sex Hormones Profile
    Renal Function tests as creatinine , Uric Acid , Blood urea. Liver Function tests as AST , ALT, ALP ECG (Electrocardiogram recording) SEX hormones as LH , FSH , and Testosterone


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Renal Functions tests. [ Time Frame: 1 day ]
    Measure the changes in the renal function due to drug addiction in different people.

  3. ECG [ Time Frame: 1 day ]
    Record the changes in the Electrocradiogram due to addiction



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are addicted for at least one year.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206411


Contacts
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Contact: Sarah A. Mohammed 0201062031286 Sara_abdelsamee@yahoo.com

Locations
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Egypt
Assiut University Recruiting
Assiut, Egypt
Sponsors and Collaborators
Assiut University

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Responsible Party: Sarah Abdelsamee Mohammed Ali, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03206411     History of Changes
Other Study ID Numbers: Addiction
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs