Health and Wellness Products for Pain

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Corticosteroids, Antipsychotics, MAOIs

Disqualifiers: Pregnancy, Liver disease, Heart disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

3826 Participants Needed

Trial Summary

What is the purpose of this trial?

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with the study products. These include anticoagulants, medications that warn against grapefruit consumption, high-dose corticosteroids, certain antibiotics, antifungals, antivirals, antipsychotics, and MAOIs. If you are taking any of these, you may need to stop or adjust them to participate.

What data supports the effectiveness of this treatment for pain?

Research shows that placebo treatments can lead to measurable changes in brain function and reduce the feeling of pain, suggesting that even treatments without active ingredients can have a real impact on pain perception. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research articles do not provide specific safety data for the treatment under its various names, but they highlight the importance of proper reporting of placebo and sham controls to understand the benefits and harms of active interventions. ^{1 4 6 7 8}

How is the placebo control treatment for pain unique?

This treatment is unique because it uses an open-label placebo, meaning participants know they are receiving a placebo, yet it can still improve well-being and reduce pain. This approach challenges the traditional belief that deception is necessary for placebos to be effective. ^{1 5 9 10 11}

Research Team

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science, Inc

Eligibility Criteria

Adults over 21 in the US who want to reduce pain with health and wellness products can join. They must be willing to take an unknown product (active or placebo) until study's end, not be pregnant/breastfeeding, have no severe heart/liver/kidney disease, not on conflicting meds like anticoagulants/high-dose steroids/MAOIs, and not heavy drinkers.

Inclusion Criteria

I am interested in a health product to manage or improve my pain.

Resides in the United States

I am willing to take a study drug without knowing if it's active or a placebo.

Exclusion Criteria

I have used chemotherapy or immunotherapy in the last 3 months.

I have severe heart disease, including heart failure or irregular heartbeats.

You drink three or more alcoholic drinks every day.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for 6 weeks, with self-reported data collected electronically

6 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants complete a final survey to assess health outcomes after the treatment period

1 week

Treatment Details

Interventions

• Placebo Control Form 1
• Relief Active Study Product 1.1 Usage
• Relief Active Study Product 1.2 Usage

Trial Overview The trial is testing different health and wellness products against placebos to see if they help with various types of pain. Participants are randomly assigned a real product or a fake one without knowing which they received until the study concludes.

Participant Groups

Group I: Active Product 3.3 Experimental Treatment 1 Intervention

Relief Product Form 3 - active product 3

Group II: Active Product 3.2 Experimental Treatment 1 Intervention

Relief Product Form 3 - active product 2

Group III: Active Product 3.1 Experimental Treatment 1 Intervention

Relief Product Form 3 - active product 1

Group IV: Active Product 2.1 Experimental Treatment 1 Intervention

Relief Product Form 2 - active product 1

Group V: Active Product 1.2 Experimental Treatment 1 Intervention

Relief Product Form 1 - active product 2

Group VI: Active Product 1.1 Experimental Treatment 1 Intervention

Relief Product Form 1 - active product 1

Group VII: Placebo Control 2 Placebo Group 1 Intervention

Relief Product Form 2 - control

Group VIII: Placebo Control 1 Placebo Group 1 Intervention

Relief Product Form 1 - control

Group IX: Placebo Control 3 Placebo Group 1 Intervention

Relief Product Form 3 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Findings from Research

A systematic review of 234 randomized placebo trials involving 10,525 patients found that placebo interventions generally do not have clinically important effects across various health conditions, with a pooled effect size indicating minimal benefit.

However, placebo interventions showed some influence on patient-reported outcomes, particularly for pain and nausea, although the effects varied widely and were often difficult to separate from reporting biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo interventions for all clinical conditions. Hróbjartsson, A., Gøtzsche, PC.[2022]

In a study of 788 patients with rheumatoid arthritis, significant improvements were observed in both subjective (pain severity) and objective (C-reactive protein and erythrocyte sedimentation rate) outcomes in the placebo group, indicating that placebo responses can affect both types of measures.

These findings suggest that the strong placebo effects seen in clinical trials could lead to underpowered studies, emphasizing the need for careful trial design to account for unexpected favorable responses in both subjective and objective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Placebo Response in Objective and Subjective Outcome Measures in Rheumatoid Arthritis Clinical Trials. Vollert, J., Cook, NR., Kaptchuk, TJ., et al.[2021]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

A review of 10 randomized controlled trials on acupuncture for pain relief found that only 6 studies reported adverse events, and most did not adequately detail how these events were collected or assessed.

The findings indicate that acupuncture trials have not fully adhered to the updated CONSORT guidelines for reporting adverse events, highlighting the need for improved documentation to ensure patient safety and better understanding of potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in acupuncture clinical trials focusing on pain. Capili, B., Anastasi, JK., Geiger, JN.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Placebo analgesia in physical and psychological interventions: Systematic review and meta-analysis of three-armed trials. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Placebo interventions for all clinical conditions. [2022]

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

Assessment of Placebo Response in Objective and Subjective Outcome Measures in Rheumatoid Arthritis Clinical Trials. [2021]

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

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]

5. Croatia pubmed.ncbi.nlm.nih.gov

[Placebo in the pain treatment]. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Inadequate description of placebo and sham controls in a systematic review of recent trials. [2020]

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

Adverse event reporting in acupuncture clinical trials focusing on pain. [2022]

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

Systematic review of enriched enrolment, randomised withdrawal trial designs in chronic pain: a new framework for design and reporting. [2022]

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

Open-Label Placebo Interventions With Drinking Water and Their Influence on Perceived Physical and Mental Well-Being. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Sham controls in device trials for chronic pain - tricky in practice-a review article. [2023]

11. Italy pubmed.ncbi.nlm.nih.gov

Credibility of placebo transcutaneous nerve stimulation and acupuncture. [2017]