Conditioning Open-Label Placebo for Spinal Cord Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spaulding Rehabilitation Hospital, Charlestown, MA
Spinal Cord Injuries+3 More
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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. Conditioning Open-Label Placebo is a treatment used to help improve symptoms for people suffering from Spinal Cord Injuries.

Eligible Conditions

  • Spinal Cord Injuries
  • Polytrauma
  • Burns

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Spinal Cord Injuries

Study Objectives

1 Primary · 22 Secondary · Reporting Duration: 6 days, 3 weeks, 6 weeks.

1 day
Qualitative Exit Interview
6 days
Functional near-infrared spectroscopy (fNIRS)
Metabolite assessment of 3-Methyl Xanthine
Metabolite assessment of Indole-3-Acetic acid
Metabolite assessment of Indole-3-Lactic acid
Metabolite assessment of Indole-3-Propionic acid
Metabolite assessment of Kynurenine
Metabolite assessment of Serotonin
Metabolite assessment of Total indoxyl sulfate
Metabolite assessment of Tryptophan
Metabolite assessment of Tyrosine
Metabolite assessment of Uric acid
Morphine Equivalent Dose Conversion (MEDC)
Numerical Opioid Side Effects (NOSE)
Pain Pressure Threshold (PPT)
Quantitative electroencephalography (qEEG)
TEX-Q
TSQM-9
Week 6
Generalized Anxiety Disorder questionnaire 7 (GAD-7)
Modified Brief Pain Inventory (BPI)
PROMIS Pain Behavior
PROMIS Pain Interference
Patient Health Questionnaire 9 (PHQ-9)

Trial Safety

Safety Progress

1 of 3

Other trials for Spinal Cord Injuries

Side Effects for

Tio R2.5
16%Asthma
6%Peak expiratory flow rate decreased
0%Breast cancer in situ
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01316380) in the Tio R2.5 ARM group. Side effects include: Asthma with 16%, Peak expiratory flow rate decreased with 6%, Breast cancer in situ with 0%.

Trial Design

2 Treatment Groups

Treatment as usual
1 of 2
Conditioning Open-Label Placebo
1 of 2
Active Control
Experimental Treatment

66 Total Participants · 2 Treatment Groups

Primary Treatment: Conditioning Open-Label Placebo · Has Placebo Group · N/A

Conditioning Open-Label Placebo
Other
Experimental Group · 1 Intervention: placebo · Intervention Types: Other
Treatment as usualNoIntervention Group · 1 Intervention: Treatment as usual · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 days, 3 weeks, 6 weeks.
Closest Location: Spaulding Rehabilitation Hospital · Charlestown, MA
Photo of massachusetts 1Photo of massachusetts 2Photo of massachusetts 3
2004First Recorded Clinical Trial
15 TrialsResearching Spinal Cord Injuries
54 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,207 Previous Clinical Trials
5,610,742 Total Patients Enrolled
1 Trials studying Spinal Cord Injuries
42 Patients Enrolled for Spinal Cord Injuries
Spaulding Rehabilitation HospitalLead Sponsor
120 Previous Clinical Trials
10,275 Total Patients Enrolled
21 Trials studying Spinal Cord Injuries
831 Patients Enrolled for Spinal Cord Injuries

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a spinal cord injury, polytrauma, or burn injury and you have pain of no more than five years of evolution.
You are admitted to the Spaulding Comprehensive Rehabilitation Unit at Spaulding Rehabilitation Hospital.
You have or have had neuropathic pain and nociceptive pain that is moderate or severe.
You have used narcotic pain medication for at least 3 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References