- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01517711
Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
August 9, 2022 updated by: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
A Double-Blind, Placebo-Controlled, Flexible-Dose Pilot Clinical Trial of Once-Daily Extended-Release Tramadol for the Treatment of PTSD
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45220
- Cincinnati VA Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tramadol ER
Tramadol in an extended release formulation with an initial dosage of 100 mg daily, increased weekly over the next two weeks, as tolerated, to a maximum of 300 mg daily
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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 Names:
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Placebo Comparator: Placebo capsule
Lactose encapsulated to match appearance of experimental drug
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician-Administered PTSD Scale (CAPS)
Time Frame: Weeks 0 (baseline),1, 2, 4, 6
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The Clinician-Administered PTSD Scale (CAPS) is an interview-based measure of severity of PTSD symptoms.
A total score is calculated with a range of 0-136, with higher numbers indicating more severe symptoms.
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Weeks 0 (baseline),1, 2, 4, 6
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Clinical Global Impression -- Improvement (CGI-I) -- Subject
Time Frame: Week 6, assessing clinician's judgment of change from week 0 to week 6
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The Clinicial Global Impression - Improvement (CGI-I) is a single item rated by a clinician.
The range is 1 (very much improved)) to 7 (very much worse).
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Week 6, assessing clinician's judgment of change from week 0 to week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scales (VAS)
Time Frame: Change from week 0 to 6
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Self-rated 100-mm visual analog scales [0 to 100 scale; higher score indicates more of the rated state] to rate poor sleep, happiness, irritability, nervousness and pain.
Change is calculated by subtracting week 6 from week 0.
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Change from week 0 to 6
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Quick Inventory of Depressive Symptoms (QIDS)
Time Frame: Weeks 0, 1, 2, 4 and 6
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Quick Inventory of Depressive Symptoms - Self Report (QIDS) is a self-report scale of severity of depression.
A total score is calculated with a range of 0 to 27, with higher numbers indicating greater severity.
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Weeks 0, 1, 2, 4 and 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Thomas Geracioti, MD, University of Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
January 23, 2012
First Submitted That Met QC Criteria
January 24, 2012
First Posted (Estimate)
January 25, 2012
Study Record Updates
Last Update Posted (Actual)
August 31, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INTRuST-Tramadol
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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