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

Lower Back Pain Clinical Trial

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

Clinical Trial Summary

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 Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01898013
Study type Interventional
Source Durham VA Medical Center
Contact
Status Completed
Phase Phase 2
Start date September 13, 2013
Completion date April 3, 2017
View Details
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