Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00167856
First received: September 9, 2005
Last updated: March 26, 2014
Last verified: February 2009
  Purpose

The purpose of this study is to evaluate the pain-relieving effects of venlafaxine hydrochloride (Effexor) in chronic neuropathic (burning, shock-like, electric) pain after spinal cord injury (SCI). Although a number of medications have been used to treat SCI pain, no drug has been consistently helpful, and, therefore, many people with SCI continue to have difficult chronic pain. Venlafaxine is a new anti-depressant drug that has not been tested for use in SCI neuropathic pain, but has been helpful for other types of neuropathic pain.


Condition Intervention
Neuropathic Pain
Pain
Spinal Cord Injuries
Drug: Venalafaxine hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Pain Intensity as measured by subject pain diaries [ Time Frame: Baseline (2 Weeks); Phase 1 (1 week at max dose); Washout (2 weeks); Phase 2 (1 week at max dose) ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2005
Study Completion Date: August 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Venlafaxine HCL (extended release)
Drug: Venalafaxine hydrochloride
Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)
Other Name: Effexor XR
Active Comparator: 2
Benztropine Mesylate
Drug: Venalafaxine hydrochloride
Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)
Other Name: Effexor XR

Detailed Description:

Persistent pain is one of the most common reasons for impaired quality of life following spinal cord injury (SCI). Although numerous interventions are often used to manage neuropathic pain following SCI, most people receive inadequate relief and continue to suffer many years after the original injury. The long-term goal of our pain research is to improve the management of chronic neuropathic pain following SCI.

This study examines the effect of Venlafaxine hydrochloride (VH) in the treatment of chronic neuropathic pain associated with SCI. VH is a second-generation, structurally novel antidepressant medication with a mild side-effect profile compared to these older tricyclic antidepressants (e.g. imipramine and amitriptyline). Previous clinical trials suggest that approximately 60-70% of people with heterogeneous neuropathic pain report at least moderate reductions in pain with older antidepressants. However, reported side-effects have been numerous, and few trials have been conducted on neuropathic pain due to SCI.

The current study is a two-period, 24-week crossover, randomized, placebo-controlled trial. A sample of 60 persons with chronic neuropathic pain and SCI will be randomly assigned to either of two treatment groups (n=30 for each group), in a double-blind fashion. One group will receive VH first and then placebo, whereas the second group will start with the placebo followed by the VH. There will be weekly contacts between the research staff and the study participants to assess pain relief and medication side effects (presence and severity). Several measures of pain intensity, psychosocial well-being, quality of life, and sensory function will be taken throughout the study to examine the effects of VH on neuropathic pain.

We expect that VH will help to relieve neuropathic pain in persons with SCI, and that this decrease in pain intensity will correlate with a reduced psychosocial impact, improved mood, increased participation in daily activities, and increased life satisfaction.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • participant must be able to swallow pills
  • fluent in English
  • incomplete or complete spinal cord injury
  • presence of at least moderately severe neuropathic pain at or below the level of injury
  • spinal cord injury at least 2 year prior to entering the study
  • pain for at least 6 months prior to entering the study
  • spinal cord injury level above L1
  • participants on anticonvulsants are considered
  • approval of primary physician

Exclusion Criteria:

  • pregnant women, or those contemplating pregnancy
  • prior history of use of Venlafaxine hydrochloride (Effexor)
  • current use of MAOI medications
  • persons who have a recent (past year) history of alcohol or drug abuse
  • persons with a history of renal disease, heart disease or uncontrolled hypertension, liver disease or hepatic cirrhosis, active major medical or psychiatric illness
  • persons with a significant post-traumatic encephalopathy from head trauma sustained at SCI
  • persons with tardive dyskinesia or narrow angle glaucoma
  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: NCT00167856

Locations
United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
Sponsors and Collaborators
Investigators
Principal Investigator: Eva G. Widerstrom-Noga, DDS PhD VA Medical Center, Miami
  More Information

Publications:
Responsible Party: Widerstrom-Noga, Eva - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00167856     History of Changes
Other Study ID Numbers: B3070-R
Study First Received: September 9, 2005
Last Updated: March 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Burning pain
Clinical trial
Effexor
Pain
Spinal cord injury
Venalafaxine
Neuropathic Pain

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

ClinicalTrials.gov processed this record on July 24, 2014