Intravenous Drug UsageNCT01831284
Correlates and Consequences of Increased Immune Activation in Injection Drug Users
An observational study of Intravenous Drug Usage, run by Rockefeller University at 1 site in United States.
Trial summary
The goal of this study is to learn how injection drug use may affect the immune system. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Intravenous Drug Usage
- What is being tested?
- Sigmoidoscopy with biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
The goal of this study is to learn how injection drug use may affect the immune system.
Read the 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.
- Conditions
- Intravenous Drug Usage
- Being tested
- Sigmoidoscopy with biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigmoidoscopy with biopsyProcedure or surgery
Sigmoidoscopy with biopsy
| Study group | Role | What they receive |
|---|---|---|
| heroin injecting drug users | Sigmoidoscopy with biopsy, in medically stable active injecting drug users Receives: Procedure: Sigmoidoscopy with biopsy | |
| healthy controls | Sigmoidoscopy with biopsy, in non-injecting controls- Receives: Procedure: Sigmoidoscopy with biopsy | |
| Former heroin injection drug users | Sigmoidoscopy with biopsy, in former injectors of heroin with or without other agents Receives: Procedure: Sigmoidoscopy with biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the behavioral and immunological correlates of increased immune activation in active and former injection drug users (IDUs) in blood and tissue.
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.
Measured: 3 months
Secondary outcomes (1)
Determine the mechanisms of increased immune activation associated with active IDU using a systems biology approach.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intravenous Drug UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Markowitz, MD, Principal investigator, Aaron Diamond AIDS Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831284
- Sponsor's protocol ID
- MMA-0774
- Status last verified
- Nov 2014
- First submitted
- 28 Feb 2013
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Markowitz M, Deren S, Cleland C, La Mar M, Silva E, Batista P, St Bernard L, Gettie N, Rodriguez K, Evering TH, Lee H, Mehandru S. Chronic Hepatitis C Virus Infection and the Proinflammatory Effects of Injection Drug Use. J Infect Dis. 2016 Nov 1;214(9):1376-1382. doi: 10.1093/infdis/jiw373. Epub 2016 Aug 11.
PubMed 27521361
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlates and Consequences of Increased Immune Activation in Injection Drug Users
- ClinicalTrials.gov ID
- NCT01831284
- Acronym / sponsor ID
- MMA-0774
- Conditions
- Intravenous Drug Usage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn how injection drug use may affect the immune system.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| heroin injecting drug users | – | Procedure: Sigmoidoscopy with biopsySigmoidoscopy with biopsy, in medically stable active injecting drug users |
| healthy controls | – | Procedure: Sigmoidoscopy with biopsySigmoidoscopy with biopsy, in non-injecting controls- |
| Former heroin injection drug users | – | Procedure: Sigmoidoscopy with biopsySigmoidoscopy with biopsy, in former injectors of heroin with or without other agents |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sigmoidoscopy with biopsySigmoidoscopy with biopsy | Procedure or surgery | Former heroin injection drug users, healthy controls, heroin injecting drug users |
Primary outcome
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.
1 secondary outcome
Determine the mechanisms of increased immune activation associated with active IDU using a systems biology approach.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Derived from this study: PubMed 27521361Markowitz M, Deren S, Cleland C, La Mar M, Silva E, Batista P, St Bernard L, Gettie N, Rodriguez K, Evering TH, Lee H, Mehandru S. Chronic Hepatitis C Virus Infection and the Proinflammatory Effects of Injection Drug Use. J Infect Dis. 2016 Nov 1;214(9):1376-1382. doi: 10.1093/infdis/jiw373. Epub 2016 Aug 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Markowitz, MD principal investigator
Aaron Diamond AIDS Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intravenous Drug Usage, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01831284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014.