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

Completed · Phase 4 · Has a placebo group

Conditions studied: Post-Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT01517711

Run by

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

People needed

40

Starts

2011-09-01

Expected to finish

2015-08-01

Last updated by the study team

2022-08-31

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati VA Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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