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Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury

NCT03906721 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-05-17

No results posted yet for this study

Summary

The use of conditioning open-label placebo (COLP) will be studied as a dose extension method to lower opioid dosage in patients with spinal cord injury, polytrauma, and burn injury. The goal is to provide the same level of pain relief with a reduced opioid dose to diminish adverse effects as well as the risk of addiction associated with narcotic treatment.

Conditions

  • Spinal Cord Injuries
  • Polytrauma
  • Burn Injury

Interventions

DRUG

Placebo

Sugar pill used to condition patients.

DRUG

Oxycodone

An opioid used for analgesia.

OTHER

Essential Oil

An aromatic oil used for conditioning.

Sponsors & Collaborators

  • Spaulding Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Ross D Zafonte, DO · Spaulding Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2021-11-01
Completion
2021-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03906721 on ClinicalTrials.gov