NCT01898013

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Durham VA Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lower Back Pain

Interventions

Type	Name	Description
DRUG	Pregnenolone
DRUG	Placebo

Timeline

• Start date: 2013-09-13
• Primary completion: 2017-04-03
• Completion: 2017-04-03
• First posted: 2013-07-12
• Last updated: 2018-10-03
• Results posted: 2018-10-03

Locations

1 site across 1 country: United States