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

September 9, 2005
March 26, 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) ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00167856
B3070-R
No
Widerstrom-Noga, Eva - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Eva G. Widerstrom-Noga, DDS PhD VA Medical Center, Miami
Department of Veterans Affairs
February 2009

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