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Correlates and Consequences of Increased Immune Activation in Injection Drug Users

Rockefeller University logo

Rockefeller University

Status

Completed

Conditions

Intravenous Drug Usage

Treatments

Procedure: Sigmoidoscopy with biopsy

Study type

Observational

Funder types

Other

Identifiers

NCT01831284
MMA-0774

Details and patient eligibility

About

The goal of this study is to learn how injection drug use may affect the immune system.

Full description

The goal of this study is to learn how injection drug use may affect the immune system. One way to measure this is by looking at the blood and the gut, or gastrointestinal tract at the same time. It is thought that activating the immune system by injection drug use may increase destruction of immune cells in the gut. To test this theory, the investigators are enrolling HIV-negative injection drug users, HIV-negative people who do not use drugs and HIV-negative former injection drug users.

Enrollment

201 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Ability to give informed consent
  • Between the ages of 18 and 55
  • Absence of medical conditions that would preclude flexible sigmoidoscopy
  • Absence of active opportunistic infection requiring active therapy including antibiotics or anti-neoplastics (note this does not include prophylactic antibiotic therapy)

Exclusion criteria

  • History of bleeding disorder
  • Platelet count below 70,000
  • INR>1.5 or PTT>2X control
  • Active use of anticoagulants or aspirin therapy that cannot be interrupted
  • Comorbid diagnosis of inflammatory bowel disease
  • Pregnancy, incarceration, mentally disabled individuals
  • HIV-1 infection
  • Currently on Hepatitis C treatment

Trial design

201 participants in 3 patient groups

heroin injecting drug users
Description:
Sigmoidoscopy with biopsy, in medically stable active injecting drug users
Treatment:
Procedure: Sigmoidoscopy with biopsy
healthy controls
Description:
Sigmoidoscopy with biopsy, in non-injecting controls-
Treatment:
Procedure: Sigmoidoscopy with biopsy
Former heroin injection drug users
Description:
Sigmoidoscopy with biopsy, in former injectors of heroin with or without other agents
Treatment:
Procedure: Sigmoidoscopy with biopsy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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