Neuropathic PainNCT00167856
Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
A study testing Venalafaxine hydrochloride in people with Neuropathic Pain and Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathic Pain, Pain, Spinal Cord Injuries
- What is being tested?
- Venalafaxine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- spinal cord injury level above L1
- participants on anticonvulsants are considered
- approval of primary physician
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neuropathic Pain, Pain, Spinal Cord Injuries
- Being tested
- Venalafaxine hydrochloride
- Keywords
- Burning pain, Clinical trial, Effexor, Pain, Spinal cord injury, Venalafaxine, Neuropathic Pain
- Medical subject headings
- Neuralgia, Pain, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venalafaxine hydrochlorideDrug
Also called Effexor XR
Norepinephrine/Serotonin Reuptake Inhibitor (NSRI)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Venlafaxine HCL (extended release) Receives: Drug: Venalafaxine hydrochloride |
| 2 | Active comparator | Benztropine Mesylate Receives: Drug: Venalafaxine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity as measured by subject pain diaries
Measured: Baseline (2 Weeks); Phase 1 (1 week at max dose); Washout (2 weeks); Phase 2 (1 week at max dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Eva G. Widerstrom-Noga, DDS PhD, Principal investigator, VA Medical Center, Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167856
- Sponsor's protocol ID
- B3070-R
- Status last verified
- Feb 2009
- First submitted
- 9 Sep 2005
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sindrup SH, Jensen TS. Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain. 1999 Dec;83(3):389-400. doi: 10.1016/S0304-3959(99)00154-2.
PubMed 10568846Defrin R, Ohry A, Blumen N, Urca G. Characterization of chronic pain and somatosensory function in spinal cord injury subjects. Pain. 2001 Jan;89(2-3):253-63. doi: 10.1016/s0304-3959(00)00369-9.
PubMed 11166482Widerstrom-Noga EG, Felipe-Cuervo E, Yezierski RP. Chronic pain after spinal injury: interference with sleep and daily activities. Arch Phys Med Rehabil. 2001 Nov;82(11):1571-7. doi: 10.1053/apmr.2001.26068.
PubMed 11689978Tasmuth T, Hartel B, Kalso E. Venlafaxine in neuropathic pain following treatment of breast cancer. Eur J Pain. 2002;6(1):17-24. doi: 10.1053/eujp.2001.0266.
PubMed 11888224Westgren N, Levi R. Quality of life and traumatic spinal cord injury. Arch Phys Med Rehabil. 1998 Nov;79(11):1433-9. doi: 10.1016/s0003-9993(98)90240-4.
PubMed 9821906
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Venlafaxine on Chronic Neuropathic Pain Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00167856
- Acronym / sponsor ID
- B3070-R
- Conditions
- Neuropathic Pain, Pain, Spinal Cord Injuries
- Keywords
- Burning pain, Clinical trial, Effexor, Pain, Spinal cord injury, Venalafaxine, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Venalafaxine hydrochlorideVenlafaxine HCL (extended release) |
| 2 | Active comparator | Drug: Venalafaxine hydrochlorideBenztropine Mesylate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venalafaxine hydrochlorideAlso: Effexor XRNorepinephrine/Serotonin Reuptake Inhibitor (NSRI) | Drug | 1, 2 |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Results publication: PubMed 10568846Sindrup SH, Jensen TS. Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain. 1999 Dec;83(3):389-400. doi: 10.1016/S0304-3959(99)00154-2.
- Results publication: PubMed 11166482Defrin R, Ohry A, Blumen N, Urca G. Characterization of chronic pain and somatosensory function in spinal cord injury subjects. Pain. 2001 Jan;89(2-3):253-63. doi: 10.1016/s0304-3959(00)00369-9.
- Results publication: PubMed 11689978Widerstrom-Noga EG, Felipe-Cuervo E, Yezierski RP. Chronic pain after spinal injury: interference with sleep and daily activities. Arch Phys Med Rehabil. 2001 Nov;82(11):1571-7. doi: 10.1053/apmr.2001.26068.
- Results publication: PubMed 11888224Tasmuth T, Hartel B, Kalso E. Venlafaxine in neuropathic pain following treatment of breast cancer. Eur J Pain. 2002;6(1):17-24. doi: 10.1053/eujp.2001.0266.
- Results publication: PubMed 9821906Westgren N, Levi R. Quality of life and traumatic spinal cord injury. Arch Phys Med Rehabil. 1998 Nov;79(11):1433-9. doi: 10.1016/s0003-9993(98)90240-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva G. Widerstrom-Noga, DDS PhD principal investigator
VA Medical Center, Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venalafaxine hydrochloride in people with Neuropathic Pain and Pain, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00167856, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.