Healing With Venlafaxine After Injury (HELP) (HELP)

Healing With Venlafaxine After Injury: A Randomized Clinical Trial of Venlafaxine Following Motor Vehicle Collision

Purpose: The purpose of this study is to demonstrate the potential efficacy of venlafaxine administration in reducing acute and chronic musculoskeletal pain in individuals presenting to the ED for evaluation after motor vehicle collision.

Participants: Participants will consist of 60 patients between the ages of 18-50 who present to the ED within 12 hours post-motor vehicle collision. Patients who report a neck pain score > 6 will be screened for further eligibility.

Procedures (methods): Using a placebo-controlled, randomized, double-blind trial design, 60 high risk patients will be randomized to venlafaxine vs. placebo in the ED. The ability of venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed during serial short-term telephone follow-ups as well as more in-depth follow-ups at 6 weeks, 4 months, and 6 months post-MVC.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Drug: Venlafaxine

Detailed Description

Results from both animal and human studies suggest that treatment with the serotonin-norepinephrine reuptake inhibitor (SNRIs) venlafaxine may reduce post-MVC pain. In addition, venlafaxine has been shown to be beneficial in reducing posttraumatic stress disorder (PTSD) symptoms, and in some patients PTSD symptoms may contribute to reinforcing pain persistence after trauma.

This phase IIB pilot trial will screen patients presenting to the ED after MVC for the presence of severe axial pain (>4 on a 0-10 numeric rating scale). Sixty of these "high risk" patients will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to decrease acute and persistent musculoskeletal axial pain will be assessed.

Results will be used to design a large-scale RCT assessing the efficacy of venlafaxine intervention in decreasing acute and persistent musculoskeletal pain in high-risk patients presenting to the ED after minor MVC.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between the ages of 18 and 59
• Presents to ED within 24 hours of MVC
• ED axial pain score greater than or equal to 4 (0-10 NRS)
• Clinically sober
• Willing to provide a blood sample
• Has a telephone
• Has regular access to Internet and an email address
• Able to speak and read English
• Permanent US citizen or has a green card
• Blood pressure reading(s) in ED that, when considered in the context of patient past and current history, in the investigator's judgment does not exceed acceptable level

Exclusion Criteria:

• Axial pain score greater than 0 in the past month (0-10 NRS)
• Clinically unstable
• Fracture (other than fracture of the phalanges)
• Substantial soft tissue injury
• Hepatic failure (acute or chronic)
• Renal failure (acute or chronic)
• Coronary artery disease, including previous MI, Angina, PCTA, etc.
• History of glaucoma
• Previous congestive heart failure
• History of seizure disorder
• History of mania or psychotic disorder
• History of suicidal ideation
• Prisoner
• History and behavior indicates, in the investigator's judgment, that the participant would likely be noncompliant with the study
• Any other condition that, in the investigator's judgment, would indicate that the patient in unsuitable for the study (e.g. might interfere with the study, confound interpretation, or endanger patient)
• Currently taking a monoamine oxidase inhibitor
• Currently taking medication with substantial interaction with venlafaxine, or which could confound interpretation of study results
• Breastfeeding
• If female, either not postmenopausal (having menses within past year), or, if childbearing potential, positive pregnancy test prior to randomization and not using a medically acceptable form of contraception
• Exceeds acceptable chronic daily opioid use prior to MVC
• Previously on venlafaxine
• Previous allergic reaction to venlafaxine
• Antidepressant use within 2 weeks of study start (4 week if Prozac)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week	Drug: Venlafaxine; Sixty patients who present following a minor motor vehicle collision will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed.; Other Names: Effexor
Active Comparator: Venlafaxine; 37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week	Drug: Venlafaxine; Sixty patients who present following a minor motor vehicle collision will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed.; Other Names: Effexor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average neck pain	The primary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) after study drug initiation through Day 31.	0-31 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic neck pain	The secondary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) between study day 38 through 6 months.	Study day 38 through 6 months

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: University of Cincinnati; Baystate Medical Center; University of North Carolina; Mayday Fund
• Investigators: Principal Investigator: Samuel A McLean, MD, MPH, University of North Carolina, Chapel Hill; Principal Investigator: Jeffrey Jones, MD, Spectrum Health Hospitals; Principal Investigator: Kirsten Rindal, MD, University of Rochester; Principal Investigator: Gregory Fermann, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Neck Pain; Venlafaxine; Musculoskeletal pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: 104106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No