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

• Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01517711
• Collaborator: U.S. Army Medical Research and Development Command (U.S. Fed)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorder	Drug: Tramadol; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Anticipated 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: Sep 1, 2011
• Actual Primary Completion Date: Sep 1, 2014
• Anticipated Study Completion Date: Jul 1, 2015

Arms and Interventions

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 Names: 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).

Outcome Measures

Primary Outcome Measures

1. Efficacy as measured by a reduction in PTSD symptoms. [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.

Secondary Outcome Measures

1. Efficacy as measured by a reduction in anxiety, "nervousness", irritability, mood, sleep, and pain. [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.

2. Efficacy as measured by a reduction in depressive symptoms. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati VA Medical Center	Cincinnati	Ohio	United States	45220

Sponsors and Collaborators

• INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• U.S. Army Medical Research and Development Command

Investigators

• Principal Investigator: Thomas Geracioti, MD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• ClinicalTrials.gov Identifier: NCT01517711
• Other Study ID Numbers: INTRuST-Tramadol
• First Posted: Jan 25, 2012
• Last Update Posted: Jan 14, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium: pharmacotherapy; combat disorders
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Tramadol

Study Results

No Results Posted as of Jan 14, 2015