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Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans

Jul 12, 2013 No Comments by

The study design is a randomized, double-blind, two-arm trial of pregnenolone and placebo to
determine the possible analgesic effects in OEF/OIF Veterans with chronic low back pain.
The total study duration is 6 weeks (followed by two-follow up phone calls). All patients
will monitor pain symptoms for one week with pain diaries, followed by a 1-week placebo-only
lead-in period, 90 subjects will be randomly assigned to one of two groups. Of these
subjects, 45 subjects will receive pregnenolone, and 45 subjects will receive placebo for 4
weeks. Patient interview assessments and laboratory studies will be performed at each
interview time point. Pregnenolone, allopregnanolone and other neurosteroid metabolites
will be determined by gas chromatography / mass spectrometry (GC/MS), proceeded by high
performance liquid chromatography (HPLC).

Clinical Trial Conditions: Chronic Low Back Pain (Musculoskeletal)

Treatments in this Clinical Trial : Pregnenolone, Placebo

Eligible Clinical Trial Participant Age : Between 18 years to 65 years

Can Healthy Volunteers Participate: No

Clinical Trial Lead Sponsor: Durham VA Medical Center

Detailed Clinical Trial Description: The study design is a randomized, double-blind, two-arm trial of pregnenolone and placebo to
determine the possible analgesic effects in OEF/OIF Veterans with chronic low back pain.
The total study duration is 6 weeks (followed by two-follow up phone calls). All patients
will monitor pain symptoms for one week with pain diaries, followed by a 1-week placebo-only
lead-in period, 90 subjects will be randomly assigned to one of two groups. Of these
subjects, 45 subjects will receive pregnenolone, and 45 subjects will receive placebo for 4
weeks. Patient interview assessments and laboratory studies will be performed at each
interview time point. Pregnenolone, allopregnanolone and other neurosteroid metabolites
will be determined by gas chromatography / mass spectrometry (GC/MS), proceeded by high
performance liquid chromatography (HPLC).

The clinical trial information was obtained from http://clinicaltrials.gov/ct2/show/NCT01898013

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By: ifood.tv