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

Primary Purpose

Post-Traumatic Stress Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Tramadol

Placebo

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring pharmacotherapy, combat disorders

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cincinnati VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tramadol ER

Placebo capsule

Arm Description

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

Lactose encapsulated to match appearance of experimental drug

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

Visual Analog Scales (VAS)

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.

Quick Inventory of Depressive Symptoms (QIDS)

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.

Full Information

NCT ID

NCT01517711

First Posted

January 23, 2012

Last Updated

August 9, 2022

Sponsor

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Collaborators

U.S. Army Medical Research and Development Command

1. Study Identification

Unique Protocol Identification Number

NCT01517711

Brief Title

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

Official Title

A Double-Blind, Placebo-Controlled, Flexible-Dose Pilot Clinical Trial of Once-Daily Extended-Release Tramadol for the Treatment of PTSD

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Collaborators

U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Stress Disorder

Keywords

pharmacotherapy, combat disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tramadol ER

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo capsule

Arm Type

Placebo Comparator

Arm Description

Lactose encapsulated to match appearance of experimental drug

Intervention Type

Drug

Intervention Name(s)

Tramadol

Other Intervention Name(s)

Ultram® ER

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Outcome Measure Information:

Title

Clinician-Administered PTSD Scale (CAPS)

Description

Time Frame

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

Title

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

Description

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).

Time Frame

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

Secondary Outcome Measure Information:

Title

Visual Analog Scales (VAS)

Description

Time Frame

Change from week 0 to 6

Title

Quick Inventory of Depressive Symptoms (QIDS)

Description

Time Frame

Weeks 0, 1, 2, 4 and 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Geracioti, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati VA Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45220

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25166484

Citation

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

Results Reference

derived

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

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