Open-Label Placebo for Spinal Cord Injury Opioid Management

Charlestown, MA

N/A

Recruiting

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with above, at, or sub-lesional neuropathic pain and nociceptive pain (musculoskeletal or visceral) that is moderate or severe (average VAS scale score of 4 or greater at time of enrollment)

Men and women aged 18 or older with traumatic and non-traumatic SCI (ASIA A-D), polytrauma, or burn injury patients from the Comprehensive Rehabilitation Program at Spaulding Rehabilitation Hospital

Must not have

History of bipolar disorder or psychosis, as self-reported

Compromised medical status due to uncontrolled pathologies such as cancer, heart failure, kidney or liver insufficiency, or any other condition which jeopardizes the patient's participation in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 days, 3 weeks, 6 weeks.

Summary

This trial will study if using a conditioning open-label placebo can help reduce opioid dosage for patients with spinal cord injury, polytrauma, and burn injury, in order to reduce side effects and the risk of addiction.

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Who is the study for?

This trial is for adults with moderate to severe pain from spinal cord injury, burns, or multiple traumas who are in the Spaulding Comprehensive Rehabilitation Unit. They must be stable, using opioids for pain but not more than a specified dose, and cannot have drug dependence history or certain medical conditions like uncontrolled cancer.Check my eligibility

What is being tested?

The study tests if a placebo given openly (patients know they're receiving it) can help reduce opioid doses while managing pain effectively in patients with serious injuries. The aim is to lessen opioid side effects and addiction risk without compromising on pain relief.See study design

What are the potential side effects?

Since this trial involves a placebo intervention (a substance with no active medication), there may not be direct side effects from the treatment itself. However, reducing opioid use could lead to withdrawal symptoms or changes in how well pain is managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe pain from nerve damage or injury.

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I am 18 or older with a spinal cord injury or severe burn from Spaulding Rehabilitation.

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I use no more than 120 mg of morphine or its equivalent.

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I have multiple injuries or have had surgery for burns, amputations, or bone issues.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of bipolar disorder or psychosis.

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I have a serious health condition that could affect my safety in the study.

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I am taking a high dose of pain medication.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 days, 3 weeks, 6 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 days, 3 weeks, 6 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 days, 3 weeks, 6 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Morphine Equivalent Dose Conversion (MEDC)

Secondary study objectives

Functional near-infrared spectroscopy (fNIRS)

Generalized Anxiety Disorder questionnaire 7 (GAD-7)

Metabolite assessment of 3-Methyl Xanthine

+19 more

Side effects data

From 2012 Phase 3 trial • 465 Patients • NCT01316380

16%

Asthma

Peak expiratory flow rate decreased

100%

80%

60%

40%

20%

Study treatment Arm

Tio R2.5

Placebo

Tio R5

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Conditioning Open-Label PlaceboExperimental Treatment1 Intervention

Days 1 to 3 will include the acquisition phase where the opioid medication will be prescribed on a schedule of 3-4 times per day and paired with an open-label placebo. Day 4 and 6 will be the evoked phase, and patients will receive only the open-label placebo pill. On day 5 the opioid medication will be re-introduced as pharmacological reinforcement.

Group II: Treatment as usualActive Control1 Intervention

Patients in the standard of care group will receive their analgesic treatment through Spaulding Pharmacy as prescribed by their treating physicians. The treatment regime will include an opioid medication at the standard recommended dosage. Participants in this group will receive the treatment orally for 6 consecutive days.

0 / 7Eligibility criteria met