Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01517711
First received: January 23, 2012
Last updated: October 24, 2013
Last verified: October 2013

January 23, 2012
October 24, 2013
September 2011
May 2014   (final data collection date for primary outcome measure)
Efficacy as measured by a reduction in PTSD symptoms. [ Time Frame: Baseline and weeks 1, 2, 4, and 6 ] [ Designated as safety issue: No ]
Efficacy will be determined by change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale (CAPS) and Clinicians Global Impressions scale.
Same as current
Complete list of historical versions of study NCT01517711 on ClinicalTrials.gov Archive Site
  • Efficacy as measured by a reduction in anxiety, "nervousness", irritability, mood, sleep, and pain. [ Time Frame: Baseline and weeks 1, 2, 4, and 6. ] [ Designated as safety issue: No ]
    Efficacy will be determined by change in anxiety, "nervousness", irritability, mood, sleep, and pain as measured by self-rated 100-mm visual analog scales.
  • Efficacy as measured by a reduction in depressive symptoms. [ Time Frame: Baseline and weeks 1, 2, 4, and 6. ] [ Designated as safety issue: No ]
    Efficacy will be determined by change in depressive symptoms as measured by the Quick Inventory of Depressive Symptoms - Self Report.
Same as current
Not Provided
Not Provided
 
Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
A Double-Blind, Placebo-Controlled, Flexible-Dose Pilot Clinical Trial of Once-Daily Extended-Release Tramadol for the Treatment of PTSD

This is a six-week pilot study testing the efficacy of tramadol extended-release (ER) for posttraumatic stress disorder (PTSD). Men and women aged 21-55 years with combat-related PTSD (n = more than 20) or PTSD resulting from a civilian trauma (n = fewer than 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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
  • Drug: Tramadol
    Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
    Other Name: Ultram® ER
  • Drug: Placebo
    Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
  • Experimental: Tramadol ER
    Intervention: Drug: Tramadol
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2014
May 2014   (final data collection date for primary outcome measure)

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 (Structured Clinical Interview for the DSM (SCID))
  3. Literacy and ability to give informed consent
  4. In women of child-conceiving potential, a negative pregnancy test and use of an approved birth control method
  5. Glasgow Coma Scale (GCS) 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)
  6. Clinically judged to be at low risk for adverse sequelae from taking tramadol
  7. Concomitant medications must be approved by the PI

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
  8. Newly started in psychotherapy (< 3months)
  9. History of hypersensitivity, allergy, or other significant adverse effects from tramadol
Both
21 Years to 55 Years
No
Contact: Alex Rybalsky, PhD 513-861-3100 ext 4878 Alexander.Rybalsky@va.gov
United States
 
NCT01517711
INTRuST-Tramadol
Yes
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Principal Investigator: Thomas Geracioti, MD University of Cincinnati
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
October 2013

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