Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
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ClinicalTrials.gov Identifier: NCT01517711 |
Recruitment Status : Unknown
Verified January 2015 by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium.
Recruitment status was: Active, not recruiting
First Posted : January 25, 2012
Last Update Posted : January 14, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post-Traumatic Stress Disorder | Drug: Tramadol Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Placebo-Controlled, Flexible-Dose Pilot Clinical Trial of Once-Daily Extended-Release Tramadol for the Treatment of PTSD |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | September 2014 |
Estimated Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Tramadol ER |
Drug: Tramadol
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).
Other Name: Ultram® ER |
Placebo Comparator: Sugar pill |
Drug: 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). |
- Efficacy as measured by a reduction in PTSD symptoms. [ Time Frame: Baseline and weeks 1, 2, 4, and 6 ]Efficacy will be determined by change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale (CAPS) and Clinicians Global Impressions scale.
- 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 will be determined by change in anxiety, "nervousness", irritability, mood, sleep, and pain as measured by self-rated 100-mm visual analog scales.
- Efficacy as measured by a reduction in depressive symptoms. [ Time Frame: Baseline and weeks 1, 2, 4, and 6. ]Efficacy will be determined by change in depressive symptoms as measured by the Quick Inventory of Depressive Symptoms - Self Report.

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517711
United States, Ohio | |
Cincinnati VA Medical Center | |
Cincinnati, Ohio, United States, 45220 |
Principal Investigator: | Thomas Geracioti, MD | University of Cincinnati |
Responsible Party: | INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium |
ClinicalTrials.gov Identifier: | NCT01517711 |
Other Study ID Numbers: |
INTRuST-Tramadol |
First Posted: | January 25, 2012 Key Record Dates |
Last Update Posted: | January 14, 2015 |
Last Verified: | January 2015 |
pharmacotherapy combat disorders |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders Tramadol Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |