A Double-Blind, Placebo-Controlled, Flexible-Dose Pilot Clinical Trial of Once-Daily Extended-Release Tramadol for the Treatment of PTSD
| City: |
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Cincinnati |
| State: |
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Ohio |
| Zip Code: |
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45220 |
| Conditions: |
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Post-Traumatic Stress Disorder |
| Purpose: |
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This is a six-week pilot study testing the efficacy of tramadol extended-release (ER) for
posttraumatic stress disorder (PTSD). Men and women aged 21-65 years with combat-related
PTSD (n=20) or PTSD resulting from a civilian trauma (n=20) will be recruited. Blinded
tramadol ER will begin with a 100 mg daily dose for the first week, with an option to
increase to 200 mg/day for the 2nd week. Dose adjustments, using a range of 100-300 mg
tramadol ER per day (or 1 to 3 placebo tabs), are permitted thereafter. The primary
hypothesis is that tramadol ER 100 to 300 mg every morning for 6 weeks will reduce the
symptoms of PTSD relative to placebo. The primary outcome measures will be PTSD symptoms as
rated by the Clinician-Administered PTSD Scale (CAPS) and Clinicians Global Impressions
scale at baseline and weeks one, two, four, and six. Assignment to blinded medication arms
will be stratified to ensure equivalence of the two arms (men and women, military and
civilian trauma).
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. Men and women, military veterans and non-veterans, aged 21-55 years
2. Active PTSD as determined by diagnostic evaluation and standardized interview [SCID]
3. In the case of non-veterans with non-military trauma, index trauma must have occurred
no more than 12 months preceding screening for study
4. Literacy and ability to give informed consent
5. In women of child-conceiving potential, a negative pregnancy test and use of an
approved birth control method
6. Glasgow Coma Scale (GCS) coma score of 15, Extension of GCS with 7-point Amnesia
Scale score of 6 (amnesia for traumatic event of 30 min or fewer) or 7 (no amnesia
for impact of head) (Nell et al 2000)
7. Clinically judged to be at low risk for adverse sequelae from taking tramadol
Exclusion Criteria:
1. Pregnant or nursing women
2. Homeless persons
3. Suicidal or homicidal ideation with plans or intent
4. History of opioid dependence or abuse
5. Psychosis or history thereof, substance dependence or abuse (other than tobacco
dependence; lifetime opioid abuse is exclusionary) within the past 60 days, anorexia
nervosa, antisocial personality disorder, or other psychiatric disorder judged by the
investigator to be more clinically significant than PTSD
6. Serious or unstable illness, endocrinopathy, or metabolic instability, including
renal insufficiency, liver disease, hydrocephalus, history of stroke, history of
seizures, history of brain tumor
7. Use of non-study medications except those approved by the PI (among others, excluded
are opioids, benzodiazepines, soporifics, quinidine, muscle relaxers,
antidepressants, antipsychotics, regular anti-inflammatory or "pain" medications)
8. Current participation in psychotherapy
9. History of hypersensitivity, allergy, or other significant adverse effects from
tramadol
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| NCT ID: |
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NCT01517711 |
| Primary Contact: |
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Principal Investigator
Thomas Geracioti, MD
University of Cincinnati
Mark Fischer
Phone: 513-861-3100 ext. 4919
Email: Mark.Fischer@va.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cincinnati, Ohio 45220
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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