NCT03206411

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

June 28, 2017

Last Update Submit

June 29, 2017

Conditions

Addiction, Substance

Outcome Measures

Primary Outcomes (1)

  • Sex Hormones Profile

    Measure the changes in the Sex Hormones (LH , FSH and Testosterone) due to drug addiction in different people.

    1 day

Secondary Outcomes (3)

  • Liver Function tests.

    1 day

  • Renal Functions tests.

    1 day

  • ECG

    1 day

Interventions

Renal and liver function tests , ECG , Sex Hormones ProfileDIAGNOSTIC_TEST

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are addicted for at least one year.

You may qualify if:

  • Patients who are addicted for at least one year.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Liver Function TestsElectrocardiography

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisHeart Function TestsDiagnostic Techniques, CardiovascularElectrodiagnosis

Central Study Contacts

Sarah A. Mohammed

CONTACT

0201062031286Sara_abdelsamee@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 2, 2017

Study Start

December 1, 2016

Primary Completion

November 30, 2017

Study Completion

November 30, 2018

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)