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

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Collaborators: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Tramadol

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