Phase 4
N=40
Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
Post-Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01517711 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Clinician-Administered PTSD Scale (CAPS) — 79.1; 81.9; 90.0; 91.0 units on a scale — p=0.286
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tramadol (Drug); Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician-Administered PTSD Scale (CAPS) |
79.1; 81.9; 90.0; 91.0; 62.5; 69.8 | 0.286 |
| PRIMARY Clinical Global Impression -- Improvement (CGI-I) -- Subject |
2.3; 2.6; 2.0; 1.6 | <0.10 |
| SECONDARY Visual Analog Scales (VAS) |
26.8; 6.7; 51.0; 32.8; -18.5; -11.0 | =0.03 sig |
| SECONDARY Quick Inventory of Depressive Symptoms (QIDS) |
11.2; 13.7; 15.5; 12.6; 8.7; 11.8 | — |
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
- Men and women, military veterans and non-veterans, aged 21-55 years
- Active PTSD as determined by diagnostic evaluation and standardized interview (Structured Clinical Interview for the DSM (SCID))
- Literacy and ability to give informed consent
- In women of child-conceiving potential, a negative pregnancy test and use of an approved birth control method
- 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)
- Clinically judged to be at low risk for adverse sequelae from taking tramadol
- Concomitant medications must be approved by the PI
Exclusion Criteria
- Pregnant or nursing women
- Homeless persons
- Suicidal or homicidal ideation with plans or intent
- History of opioid dependence or abuse
- 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
- Serious or unstable illness, endocrinopathy, or metabolic instability, including renal insufficiency, liver disease, hydrocephalus, history of stroke, history of seizures, history of brain tumor
- Use of non-study medications except those approved by the PI
- Newly started in psychotherapy (< 3months)
- History of hypersensitivity, allergy, or other significant adverse effects from tramadol
Data sourced from ClinicalTrials.gov (NCT01517711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.