Overview

This trial is active, not recruiting.

Condition post-traumatic stress disorder
Treatments tramadol, placebo
Phase phase 4
Sponsor INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborator U.S. Army Medical Research and Materiel Command
Start date September 2011
End date September 2014
Trial size 40 participants
Trial identifier NCT01517711, INTRuST-Tramadol

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
tramadol Ultram® ER
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).
(Placebo Comparator)
placebo
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).

Primary Outcomes

Measure
Efficacy as measured by a reduction in PTSD symptoms.
time frame: Baseline and weeks 1, 2, 4, and 6

Secondary Outcomes

Measure
Efficacy as measured by a reduction in anxiety, "nervousness", irritability, mood, sleep, and pain.
time frame: Baseline and weeks 1, 2, 4, and 6.
Efficacy as measured by a reduction in depressive symptoms.
time frame: Baseline and weeks 1, 2, 4, and 6.

Eligibility Criteria

Male or female participants from 21 years up to 55 years old.

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

Additional Information

Official title A Double-Blind, Placebo-Controlled, Flexible-Dose Pilot Clinical Trial of Once-Daily Extended-Release Tramadol for the Treatment of PTSD
Principal investigator Thomas Geracioti, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium.