Healing With Venlafaxine After Injury (HELP)

Sponsor

Rhode Island Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01716377

Collaborator

Mayday Fund (Other), University of North Carolina (Other), University of Cincinnati (Other), Baystate Medical Center (Other)

Enrollment

Locations

Arms

Duration (Months)

6.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Neck Pain	Drug: Venlafaxine	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

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

Other Names:

Effexor

Outcome Measures

Primary Outcome Measures

Average neck pain [0-31 Days]
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 [Study day 38 through 6 months]
The secondary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) between study day 38 through 6 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Spectrum Health	Grand Rapids	Michigan	United States	49503
2	University of Rochester Medical Center	Rochester	New York	United States	14642
3	University of Cincinnati	Cincinnati	Ohio	United States	45267

Sponsors and Collaborators

Rhode Island Hospital
Mayday Fund
University of North Carolina
University of Cincinnati
Baystate Medical Center

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