Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Tramadol; Placebo
Intervention description: 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).; 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).
Intervention MeSH terms: Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: pharmacotherapy; combat disorders

Summary:

      This was 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
      or PTSD resulting from a civilian trauma were recruited. Blinded tramadol ER was begun 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), were permitted thereafter. The primary hypothesis was that tramadol ER 100 to 300 mg
      every morning for 6 weeks would reduce the symptoms of PTSD relative to placebo. The primary
      outcome measures were 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.
    

Eligibility 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