Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This was a single-site, double-blind, placebo-controlled, randomized, 6-week, parallel-group,
      flexible-dose outpatient trial of tramadol ER 100-300 mg once every morning for PTSD.
      Double-blinded clinical outcome measures were obtained during screening, and at weeks 0
      (pre-randomization), 1, 2, 4, and 6; outcome was also assessed at week 7, the follow-up and
      study discharge visit, which occurred one week after the discontinuation of study medicine.
      Tramadol ER (or placebo) was started at 100 mg daily and increased weekly over the next two
      weeks, as tolerated, to a maximum of 300 mg daily. Dose change was also permitted at week 4.
      Matching drug and placebo were prepared by a research pharmacy using over-encapsulation in
      locking DB capsules supplied by Capsugel. Lactose was used as a filler to attain uniformity
      in weight. Randomization used a 1:1 allocation ratio and was via a block design, with
      stratification by military service. Other than the research pharmacists, all study personnel,
      all staff, and all subjects were blind.
    

Intervention name(s): Tramadol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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).
Other intervention name(s): Ultram® ER
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pharmacotherapy; combat disorders