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Open-Label Placebo for Spinal Cord Injury Opioid Management

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.
Awards & highlights

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.

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.

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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Morphine Equivalent Dose Conversion (MEDC)
Secondary outcome measures
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
6%
Peak expiratory flow rate decreased
100%
80%
60%
40%
20%
0%
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.

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor
135 Previous Clinical Trials
10,934 Total Patients Enrolled
3 Trials studying Burns
67 Patients Enrolled for Burns
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,517 Total Patients Enrolled

Media Library

Conditioning Open-Label Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05351333 — N/A
Burns Research Study Groups: Treatment as usual, Conditioning Open-Label Placebo
Burns Clinical Trial 2023: Conditioning Open-Label Placebo Highlights & Side Effects. Trial Name: NCT05351333 — N/A
Conditioning Open-Label Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05351333 — N/A
~23 spots leftby Jul 2025
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