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
  Purpose

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).


Condition Intervention Phase
Post-Traumatic Stress Disorder
Drug: Tramadol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Flexible-Dose Pilot Clinical Trial of Once-Daily Extended-Release Tramadol for the Treatment of PTSD

Resource links provided by NLM:


Further study details as provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tramadol ER 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
Placebo Comparator: Sugar pill 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).

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517711

Contacts
Contact: Alex Rybalsky, PhD 513-861-3100 ext 4878 Alexander.Rybalsky@va.gov

Locations
United States, Ohio
Cincinnati VA Medical Center Recruiting
Cincinnati, Ohio, United States, 45220
Principal Investigator: Thomas Geracioti, MD         
Sponsors and Collaborators
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Thomas Geracioti, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier: NCT01517711     History of Changes
Other Study ID Numbers: INTRuST-Tramadol
Study First Received: January 23, 2012
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:
pharmacotherapy
combat disorders

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Disease
Stress Disorders, Post-Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014