Healing With Venlafaxine After Injury (HELP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Rhode Island Hospital
Sponsor:
Collaborators:
Mayday Fund
University of North Carolina
University of Cincinnati
Information provided by (Responsible Party):
Francesca Beaudoin, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01716377
First received: October 25, 2012
Last updated: August 4, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention Phase
Neck Pain
Drug: Venlafaxine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Healing With Venlafaxine After Injury: A Randomized Clinical Trial of Venlafaxine Following Motor Vehicle Collision

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Average neck pain [ Time Frame: 0-31 Days ] [ Designated as safety issue: Yes ]
    The primary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) after study drug initiation through Day 31.


Secondary Outcome Measures:
  • Chronic neck pain [ Time Frame: Study day 38 through 6 months ] [ Designated as safety issue: Yes ]
    The secondary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) between study day 38 through 6 months.


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 Name: Effexor

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716377

Contacts
Contact: Samuel A McLean, MD, MPH 919-843-5931 smclean@aims.unc.edu
Contact: Andrea Y Liu, BS 919-966-7177 ayliu@aims.unc.edu

Locations
United States, Michigan
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Chad Sutliffe, MEd, MHA    616-486-2044    chad.sutliffe@spectrumhealth.org   
Principal Investigator: Jeffrey Jones, MD         
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Kian Merchant-Borna, MPH    585-275-2909    Kian_Merchant-Borna@URMC.Rochester.edu   
Principal Investigator: Kirsten Rindal, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Jillian Picard    513-558-8983    picardjk@ucmail.uc.edu   
Principal Investigator: Gregory Fermann, MD         
Sponsors and Collaborators
Rhode Island Hospital
Mayday Fund
University of North Carolina
University of Cincinnati
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
  More Information

No publications provided

Responsible Party: Francesca Beaudoin, Assistant Professor of Emergency Medicine, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01716377     History of Changes
Other Study ID Numbers: 104106
Study First Received: October 25, 2012
Last Updated: August 4, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
Neck Pain
Musculoskeletal pain
Venlafaxine

Additional relevant MeSH terms:
Neck Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on August 31, 2015