Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuropathic Pain; Pain; Spinal Cord Injuries
Intervention: Venalafaxine hydrochloride (Drug)
Phase: N/A
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s): Eva G. Widerstrom-Noga, DDS PhD, Principal Investigator, Affiliation: VA Medical Center, Miami
Summary
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.
Clinical Details
Official title: Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Pain Intensity as measured by subject pain diaries
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
VA Medical Center, Miami, Miami, Florida 33125, United States
Additional Information
Starting date: June 2005
Last updated: March 26, 2014
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