Ignite Creation Date:
2024-05-06 @ 12:11 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01517711
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2012-01-23
Brief Title:
Tramadol Extended-Release ER for Posttraumatic Stress Disorder PTSD
Sponsor:
INTRuST Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Organization:
INTRuST Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Flexible-Dose Pilot Clinical Trial of Once-Daily Extended-Release Tramadol for the Treatment of PTSD
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None