We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Correlates and Consequences of Increased Immune Activation in Injection Drug Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01831284
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : November 6, 2014
Information provided by (Responsible Party):
Rockefeller University

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

Condition or disease Intervention/treatment
Intravenous Drug Usage Procedure: Sigmoidoscopy with biopsy

Detailed 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.

Study Type : Observational
Actual Enrollment : 201 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlates and Consequences of Increased Immune Activation in Injection Drug Users
Study Start Date : December 2012
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Drug Abuse
U.S. FDA Resources

Group/Cohort Intervention/treatment
heroin injecting drug users
Sigmoidoscopy with biopsy, in medically stable active injecting drug users
Procedure: Sigmoidoscopy with biopsy
Sigmoidoscopy with biopsy
healthy controls
Sigmoidoscopy with biopsy, in non-injecting controls-
Procedure: Sigmoidoscopy with biopsy
Sigmoidoscopy with biopsy
Former heroin injection drug users
Sigmoidoscopy with biopsy, in former injectors of heroin with or without other agents
Procedure: Sigmoidoscopy with biopsy
Sigmoidoscopy with biopsy

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
Sigmoidoscopy with biopsy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Group 1: HIV-uninfected, active IDU defined as a minimum of 3 injections of heroin per week (N=48)

Group 2: Non-injecting controls defined as no lifetime use of injection drugs and no illicit non-injection opiate or cocaine for at least 3 years (N=48)

Group 3: Former injectors of heroin with/without other agents will be recruited and followed after approximately 1 month (N=48) and 3 months (N=48) from the time of last injection.

All groups will be matched for age, sex, and race/ethnicity. Groups 1 and 3 will be matched for Hepatitis C status and HCV RNA levels. Group 1 subjects will be studied twice; at baseline, at 1-2 months to assess stability of findings. Group 2 will be studied once; Group 3 will be studied at 1 and 3 months after ceasing injections.


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

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): NCT01831284

United States, New York
The Rockfeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Principal Investigator: Martin Markowitz, MD ADARC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01831284     History of Changes
Other Study ID Numbers: MMA-0774
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents