Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167856
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : March 27, 2014
Information provided by:
VA Office of Research and Development

September 9, 2005
September 14, 2005
March 27, 2014
June 2005
August 2007   (Final data collection date for primary outcome measure)
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) ]
Average of self-report pain ratings during the week before any treatment is introduced, during the last week of drug treatment, and during the last week of placebo
Complete list of historical versions of study NCT00167856 on Archive Site
Not Provided
Detailed pain reports of pain intensity, aggravating and relieving factors associated with pain, psychosocial factors, quality of life measures, quantitative sensory testing, patient’s global impression of change score
Not Provided
Not Provided
Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Neuropathic Pain
  • Pain
  • Spinal Cord Injuries
Drug: Venalafaxine hydrochloride
Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)
Other Name: Effexor XR
  • Experimental: 1
    Venlafaxine HCL (extended release)
    Intervention: Drug: Venalafaxine hydrochloride
  • Active Comparator: 2
    Benztropine Mesylate
    Intervention: Drug: Venalafaxine hydrochloride

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2008
August 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Widerstrom-Noga, Eva - Principal Investigator, Department of Veterans Affairs
VA Office of Research and Development
Not Provided
Principal Investigator: Eva G. Widerstrom-Noga, DDS PhD VA Medical Center, Miami
VA Office of Research and Development
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP