Relistor Injectable Product for Chronic Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
Clinical Research Unit at the University of Alabama at Birmingham, Birmingham, AL
+1 More
Relistor Injectable Product - Drug
Eligibility
18+
All Sexes
Eligible conditions
Chronic Pain

Study Summary

Chronic Widespread Pain in HIV: Novel Mechanisms and Therapeutics

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Eligible Conditions

  • Chronic Pain
  • Chronic Pain, Widespread

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Relistor Injectable Product will improve 1 primary outcome and 2 secondary outcomes in patients with Chronic Pain. Measurement will happen over the course of At baseline (study visit 1).

At baseline (study visit 1)
Measuring endogenous opioid peptides in plasma and peripheral leukocytes
Day 7
McGill Pain Questionnaire-Short Form
Quantitative sensory testing (QST)

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

No Control Group
HIV negative without chronic widespread pain

This trial requires 200 total participants across 4 different treatment groups

This trial involves 4 different treatments. Relistor Injectable Product is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

HIV negative without chronic widespread pain
Drug
50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.
HIV negative with chronic widespread pain
Drug
50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.
HIV positive with chronic widespread pain
Drug
50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.
HIV positive without chronic widespread pain
Drug
50 Participants will be randomly administered saline or RELISTOR (Individuals weighing 38-<62 kg will receive an 8 mg dose; those weighing 62-114 kg will receive a 12 mg dose; Participants weighing more than 114 kg will receive 0.15 mg/kg) in counterbalance between visit 1 and visit 2.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: study visit 2 will occur at least 5-7 days after the first visit
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly study visit 2 will occur at least 5-7 days after the first visit for reporting.

Who is running the study

Principal Investigator
S. A.
Prof. Saurabh Aggarwal, Assistant Professor in the Department of Anesthesiology
University of Alabama at Birmingham

Closest Location

Clinical Research Unit at the University of Alabama at Birmingham - Birmingham, AL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Confirmed HIV diagnosis and currently a patient in the UAB 1917 HIV Clinic
Age 19 - 65; the lower end of this age range was chosen to capture young adults with HIV infection, and participants over 65 years are increasingly likely to meet one or more

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 is chronic pain?

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Chronic pain is a serious issue due to its impact on patient's quality of life and may cause physical instability and mental instability. The most common chronic disease is pain.

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How many people get chronic pain a year in the United States?

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Chronic pain occurs in the U.S. in most people at some time during their adult life and affects more than half of all adults at some point in time.

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What are common treatments for chronic pain?

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A wide variety of pharmacological and nonpharmacological treatments are used to manage chronic pain. Many of these medications are in their infancy or are not approved by the U.S. Food and Drug Administration for chronic pain management. These discrepancies between current treatment guidelines and clinical practice call for greater research regarding the most effective treatments for chronic pain.

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What causes chronic pain?

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In the vast majority of patients in whom the clinical picture of pain is consistent with the diagnosis of chronic pain a benign, non-dysregulated process like trauma or inflammation is the most likely cause for pain. In patients with multiple symptoms compatible with degenerative joint disease or lumbar stenosis this explanation is less convincing. The high association of all chronic pain complaints in patients with degenerative spinal abnormalities may be due to the mechanical compression of the pain trigger point by the degenerative changes in the spine. However the presence of low back pain does not preclude all serious causes for chronic neck and/or head pain. Chronic neck pain may be associated with any number of pathological conditions, e.g.

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What are the signs of chronic pain?

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Signs of [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) can include unexplained pain, decreased functioning, and a sense of hopelessness. Individuals experiencing chronic pain have an increased risk of poor health outcomes. Many people who have chronic pain have not discussed their pain. Those who have experienced chronic pain often perceive that no one can understand their pain. They report that their pain is a constant and unexplained problem. Many people who have chronic pain believe their pain to be beyond the control of anything medical professionals can offer.

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Can chronic pain be cured?

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Many people with disabling pain and a long history of unsuccessful attempts to control it continue to struggle. Recent findings suggests that people with severe, unremitting chronic pain are more likely to achieve pain relief when a combination of a multidisciplinary care program that combines multimodal strategies, as well as supportive therapies as self-management strategies, are utilized.

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What is the latest research for chronic pain?

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We want to get more information about why many [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) patients cannot get enough sleep and why they do not get enough exercise. We want to know what doctors are doing about chronic pain, whether there is a place for alternative medicine in our clinic and in our society. We want to know more about the current status of new treatments in chronic pain and to see the impact they might have on our patients, especially if they do not help them or worsen their pain The information on physical activity might help some chronic pain patients in their treatment of their disease.

Unverified Answer

Is relistor injectable product safe for people?

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Relistor injectables were associated with more adverse events compared with Relistor IM solutions. Relistor injectables were also found to be associated with less pain at injection compared with Relistor IM solutions, suggesting that it is the drug that causes adverse effects.

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What are the common side effects of relistor injectable product?

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Relistor injectables are safe and effective for the reduction of intramuscular pain, and all major side effects associated with other opioids are also observed. The most frequent adverse effect observed with the injection of Relistor injectable was local redness in the injection site which can lessen user satisfaction with the injection. Although the risk of developing addiction during the long term use of Relistor is low, the long-term use of Relistor may result in dependence associated with opioid-related side effects.

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Does relistor injectable product improve quality of life for those with chronic pain?

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Results indicate that use of RIKP to relieve [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) was not associated with significantly higher quality of life outcomes than placebo at 4 months (posttreatment). Improvements in pain, functioning, and physical vitality were observed at 12 months posttreatment, indicating that improvements were maintained 12 months after treatment completion.

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What is relistor injectable product?

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Relistor is a new injectable product and it has several attractive features, including ease of use, fast onset of action, low cost, and no detectable pain or systemic effects or addiction. In our opinion, relistor deserves a wider use in clinical practice for improving the patient’s treatment benefits.

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What is the primary cause of chronic pain?

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The majority of pain syndromes are believed to be caused by primary somatic causes. The most common of these primary somatic causes are musculoskeletal in etiology, followed by endocrine (both somatotropic and adrenomedullary) and the cardiovascular system (atherosclerotic disease, arterial insufficiency, arrhythmias, hyperthyroidism, hypertension, cardiac valve prolapse, pulmonary hypertension, valvular heart disease, pericardial effusion, and myocardial infarction).

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See if you qualify for this trial
Get access to this novel treatment for Chronic Pain by sharing your contact details with the study coordinator.