Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans
Status:
Completed
Trial end date:
2017-04-03
Target enrollment:
Participant gender:
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).