Correlates and Consequences of Increase… | Clinical Trial

Key information

Conditions

Intravenous Drug Usage

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Rockfeller University

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sigmoidoscopy with biopsy

Procedure

Sigmoidoscopy with biopsy

Primary outcomes

Examine the behavioral and immunological correlates of increased immune activation in active and former injection drug users (IDUs) in blood and tissue.

Time frame: 3 months

Detailed assessments of blood and GI tissue including measurements of HCV viremia in 1) active HIV-1-uninfected IDUs (N=48) 2) a cohort of individuals entering or in drug treatment programs who have stopped injecting for approximately 1 and 3 months (N=48), the majority of whom we anticipate will be infected with HCV; and 3) non-injecting controls (N=48). In addition to obtaining blood and tissue, we will collect behavioral data including injection and other drug use and sexual behaviors.

Secondary outcomes

Determine the mechanisms of increased immune activation associated with active IDU using a systems biology approach.

Time frame: 3 months

This study will isolate specific cell populations from the peripheral blood as well as the GALT that mediate innate and adaptive immune responses. We will perform transcriptional profiling with the goal of identifying gene expression patterns of a-priori defined biological pathways and functional categories that associate with phenotypes of interest. Finally to complement and clarify the results of our in vivo studies, we will examine the in vitro effects of adding morphine and methadone and withdrawing opiates on T cell subsets of interest using a systems biology approach.

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Apr 15, 2013
Registry last updated: Nov 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed