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

NCT01517711 | Completed Phase 4 Results DMC

• 1 other identifier: INTRuST-Tramadol
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

pharmacotherapy; combat disorders

Outcome Measures

Primary Outcomes (2)

• Clinician-Administered PTSD Scale (CAPS)

  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.

  Weeks 0 (baseline),1, 2, 4, 6

• Clinical Global Impression -- Improvement (CGI-I) -- Subject

  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).

  Week 6, assessing clinician's judgment of change from week 0 to week 6

Secondary Outcomes (2)

• Visual Analog Scales (VAS)

  Change from week 0 to 6

• Quick Inventory of Depressive Symptoms (QIDS)

  Weeks 0, 1, 2, 4 and 6

Study Arms (2)

Tramadol ER

EXPERIMENTAL

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

Drug: Tramadol

Placebo capsule

PLACEBO COMPARATOR

Lactose encapsulated to match appearance of experimental drug

Drug: Placebo

Interventions

Tramadol DRUG

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).

Also known as: Ultram® ER

Tramadol ER

Placebo DRUG

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 capsule

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Cincinnati VA Medical Center

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• Geracioti TD. Tramadol treatment of combat-related posttraumatic stress disorder. Ann Clin Psychiatry. 2014 Aug;26(3):217-21.

  PMID: 25166484 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Results Point of Contact

• Title: Dr. Thomas Geracioti, Principle Investigator
• Organization: University of Cincinnati College of Medicine

thomas.geracioti@uc.edu

513-748-9825

Study Officials

• Thomas Geracioti, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 25, 2012
• Study Start: September 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: August 31, 2022
• Results First Posted: August 31, 2022

Record last verified: 2022-08

Locations

US (1)