Healing With Venlafaxine After Injury (HELP)

NCT01716377 | Completed Phase 2 DMC

• 1 other identifier: 104106
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Neck Pain

Keywords

Neck Pain; Musculoskeletal pain; Venlafaxine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Chronic neck pain

  Study day 38 through 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week

Drug: Venlafaxine

Venlafaxine

ACTIVE COMPARATOR

37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week

Drug: Venlafaxine

Interventions

Venlafaxine DRUG

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.

Also known as: Effexor

Placebo; Venlafaxine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Mayday Fund: collaborator
• University of North Carolina: collaborator
• University of Cincinnati: collaborator
• Baystate Medical Center: collaborator

Study Sites (3)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Neck Pain; Musculoskeletal Pain

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Samuel A McLean, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Jeffrey Jones, MD

  Corewell Health West

  PRINCIPAL INVESTIGATOR

• Kirsten Rindal, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Gregory Fermann, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)