Treatment for Inflammation

Phase-Based Estimates
1
Effectiveness
1
Safety
Duke University Medical Center, Durham, NC
Inflammation+5 More
Eligibility
18 - 65
All Sexes
Eligible conditions
Inflammation

Study Summary

Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury

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Eligible Conditions

  • Inflammation
  • Marijuana Use
  • Cognition
  • Human Immunodeficiency Virus (HIV) Infections
  • Cannabis
  • Neuroimaging

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 11 primary outcomes in patients with Inflammation. Measurement will happen over the course of baseline, 1-year follow-up, and 2-year follow-up.

baseline, 1-year follow-up, and 2-year follow-up
Change in axonal damage was measured by neurofilament light (NfL) protein
Change in axonal loss and injury as measured by axonal diffusivity (AD)
Change in demyelination or dysmyelination as measured by radial diffusivity (RD)
Change in extracellular tissue edema as measured by non-restricted fraction (NF)
Change in gray matter as measured by cortical area and thickness and cortical and subcortical volume
Change in inflammation-related cellularity as measured by restricted fraction (RF)
Change in neurocognitive function as measured by neuropsychological battery
Change in neuronal integrity as measured by N-acteyl aspartate (NAA)
Change in neuronal-glial interaction as measured by Glutamate + glutamine (GLX)
Change in overall white matter integrity as measured by fractional anisotropy (FA)
Change in white matter integrity as measured by white matter tract streamline count

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Groups

Control

This trial requires 220 total participants across 1 different treatment groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1-year follow-up, and 2-year follow-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 1-year follow-up, and 2-year follow-up for reporting.

Closest Location

Duke University Medical Center - Durham, NC

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No current marijuana use (MJ- groups only)
current engagement in HIV care (HIV+ participants only)
verified HIV status
Current marijuana use (MJ+ groups only)
receipt of cART as first-line of treatment (HIV+ participants only)
stable cART regimen (HIV+ participants only)
undetectable HIV RNA viral load for >1 year (HIV+ participants only)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes inflammation?

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There is a clear association between inflammation and depression: a low threshold for inflammation may be an indicator of depression. However, there is currently no explanation for the mechanism of this effect.

Unverified Answer

What are the signs of inflammation?

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This article summarizes the signs of inflammation to health professionals as they enter the clinic. The signs of inflammation are not uniform and the underlying pathology must be suspected.

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Can inflammation be cured?

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Acute inflammation is not a rare state in the course of evolution but it is controllable. Treatment with low doses of steroid agents can be an alternative to high doses of anti-inflammatories which have to be reserved for severe cases which are untreatable with local and systemic agents.

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What are common treatments for inflammation?

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Treatments for inflammatory diseases often have multiple uses. Common treatments include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, antihistamines, and NSAID-related gastrointestinal bleeding. Other options include corticosteroid injections, compression garments, and physical therapy.\n

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How many people get inflammation a year in the United States?

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Although the prevalence of inflammatory diseases tripled between 1970 and 1997, a significant proportion of persons in the general population had evidence of inflammatory disease in one year. The rate of inflammatory disease increased from 3.5% for women and 7% of men aged 55 to 59 years in 1970 to 8.2% and 9.9% in 1997, respectively.

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What is inflammation?

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Inflammation is a process that is initiated in the body and leads to the production of a variety of chemicals and molecules. In general, inflammation is a response to certain bacterial or viral infections, injuries, and various other external factors. The brain has also been implicated in various inflammatory diseases; however, the role of inflammation in schizophrenia remains unclear. More research is required to clarify the relationship between inflammation in the brain and this disorder.

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Does treatment improve quality of life for those with inflammation?

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Data from a recent study shows that corticosteroid treatment has an impact on pain, mood, and quality of life, both acutely and for many months (up to 1 year) following withdrawal. These data support the belief that there is a beneficial effect of glucocorticoid treatment on patient quality of life, in addition to the improvement seen in clinical symptomatology with reduction in inflammation.

Unverified Answer

What is treatment?

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The treatment of RA patients with corticosteroids should be based on the clinical history and the intensity of the disease. However, patients with other autoimmune diseases have different criteria for treatment initiation and use of immunosuppressive therapy.

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Is treatment typically used in combination with any other treatments?

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The majority of respondents in both groups reported to use treatment in combination with another treatment. However, there were few treatments that were used only in combination with treatment, and there was more use of medication in combination with another treatment than in monotherapy.

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Who should consider clinical trials for inflammation?

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Clinical trials should be considered for patients on routine care who suffer prolonged inflammation, with a history of inflammatory bowel or heart disease. Also, trials may be considered for patients with no or minimal ongoing ongoing long-term inflammatory disease if the patient is willing to participate; a negative trial result is reassuring in patients with ongoing or potential long-term, ongoing inflammation.

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Have there been other clinical trials involving treatment?

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Clinical Trials for osteoarthritis are quite numerous, but there are very few for treatment for osteoarthritis. This review describes clinical trials that involve a treatment option for osteoarthritis. For more information on clinical trials involving a treatment option for osteoarthritis, see Overview of Osteoarthritis Clinical Trials.

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Does inflammation run in families?

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We observed an association between familial inflammatory bowel disease and elevated markers of inflammation. This underscores the need to further delineate the genetic etiology driving hereditary susceptibility to chronic inflammation and to unravel the underlying mechanisms of genetic susceptibility to inflammatory bowel disease with a goal of developing new therapeutic interventions.

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