Kindolor for Chronic Pain

Overseen By Administrative Assistant

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Lohocla Research Corporation

Must not be taking: Cannabis, MAOIs, CYP3A4 inhibitors

Disqualifiers: Drug sensitivity, Alcohol use, Hepatitis, others

Compensation: Varies

Number of Visits: 2

Duration: 2 days

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any over-the-counter or prescription medications, vitamins, and herbal supplements at least 2 weeks before the study starts.

What safety data exists for Kindolor or similar treatments for chronic pain?

The safety of treatments for chronic pain, including opioids, often involves managing side effects like constipation, sedation, and potential dependence. While opioids are generally safe when side effects are managed, they can cause adverse effects in various body systems. Tramadol, a weak opioid, has a better safety profile compared to traditional opioids. ^{1 2 3 4 5}

How does the drug Kindolor differ from other treatments for chronic pain?

Kindolor may be unique in its approach to chronic pain management by potentially involving mechanisms similar to those of ketamine, which affects various receptors and channels in the brain to provide pain relief. Unlike standard treatments, ketamine is often used when other pain relief options have failed, making it a 'third line' option for chronic pain. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this study is to test Kindolor in healthy adults. The main questions it aims to answer are: * What is the safe dose of Kindolor in healthy volunteers? * How is Kindolor metabolized by the human body? Participants will undergo medical tests before and after receiving Kindolor or a placebo to see if there is any difference between the groups.

Research Team

Mark Wallace, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for healthy adults who can participate in a study to determine the safe dosage of Kindolor, a drug intended for chronic pain management. Participants will be closely monitored through medical tests before and after receiving the medication.

Inclusion Criteria

I am a healthy adult between 18 and 55 years old.

My lab tests were normal at my last check-up.

Expected to complete the study protocol

Exclusion Criteria

History of significant sensitivity to any drug

My drug test was positive for certain substances.

My kidney function test shows abnormal results.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive Kindolor or placebo and remain in the clinic for safety assessments and blood collections

2 days

In-patient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

1 visit (in-person)

Treatment Details

Interventions

• Kindolor

Trial Overview The study is testing different doses of Kindolor Tosylate compared to a placebo. The focus is on finding out what dose is safe and how the body processes it. Volunteers are randomly assigned to receive either Kindolor or an inactive substance.

Participant Groups

Group I: Kindolor Cohort 4 Experimental Treatment 1 Intervention

Kindolor Tosylate 6 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq

Group II: Kindolor Cohort 3 Experimental Treatment 1 Intervention

Kindolor Tosylate 3 tablets dose 300mg NPO for 8hrs x1 AM PO ex aq

Group III: Kindolor Cohort 2 Experimental Treatment 1 Intervention

Kindolor Tosylate tablet 1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq

Group IV: Kindolor Cohort 1 Experimental Treatment 1 Intervention

Kindolor Tosylate 1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq

Group V: Placebo Comparator Placebo Group 1 Intervention

Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq

Who Is Running the Clinical Trial?

Lohocla Research Corporation

Lead Sponsor

Trials

2

Recruited

60+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Only 49% of randomized clinical trials (RCTs) for chronic pain in children identified a primary outcome measure, highlighting a significant gap in standardized reporting practices.

Less than 50% of the studies adhered to recommended guidelines for reporting adverse events, and discussions on recruitment and retention challenges were often inadequate, indicating a need for improved trial design and reporting in pediatric pain research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Reporting Characteristics of Clinical Trials of Select Chronic and Recurrent Pediatric Pain Conditions: An Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks Systematic Review. Connolly, MR., Chaudari, JY., Yang, X., et al.[2022]

Opioids can be effective and relatively safe options for managing pain, but they are often avoided due to concerns about potential side effects and adverse events.

The side effects of opioids can affect multiple body systems, but with proper management and quick intervention, these effects can be addressed, allowing opioids to be used safely and effectively for pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. Herndon, CM., Kalauokalani, DA., Cunningham, AJ., et al.[2019]

Ketamine shows moderate to weak evidence for efficacy in managing chronic pain, with level II evidence supporting its use for conditions like fibromyalgia and ischemic pain, while also being considered a 'third line' option when standard treatments fail.

For specific pain conditions such as phantom limb pain and postherpetic neuralgia, ketamine has demonstrated substantial pain relief, indicating its potential as an effective treatment in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine in chronic pain management: an evidence-based review. Hocking, G., Cousins, MJ.[2022]

A meta-analysis of 12 studies involving 88 patients indicates that Ketamine significantly reduces neuropathic pain compared to placebo, although the effects are typically short-lived after administration.

Ketamine has shown promise as an alternative to opioids for chronic pain management, with some studies reporting positive long-term outcomes, but further research with larger sample sizes is needed to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ketamine for treatment of chronic pain: meta-analysis]. Wiedemann, B.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Study of wrist-ankle acupuncture therapy for optimizing anaesthesia scheme of painless gastroscopy and improving painless gastroscopy related complications. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Design and Reporting Characteristics of Clinical Trials of Select Chronic and Recurrent Pediatric Pain Conditions: An Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks Systematic Review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Opioid Analgesia and Opioid-Induced Adverse Effects: A Review. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Pharmacological aspects of successful long-term analgesia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Ketamine in chronic pain management: an evidence-based review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

AAPT Diagnostic Criteria for Chronic Sickle Cell Disease Pain. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Preliminary construct validity of patient-reported outcomes to assess chronic pain in adults with sickle cell disease. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Precision, integrative medicine for pain management in sickle cell disease. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

[Ketamine for treatment of chronic pain: meta-analysis]. [2019]