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

NCT01898013 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2018-10-03

Study results available
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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

DRUG

Pregnenolone

DRUG

Placebo

Sponsors & Collaborators

  • Durham VA Medical Center

    lead FED

Principal Investigators

  • Jennifer C. Naylor, PhD · Durham VA Medical Center

  • Christine E Marx, MD · Durham VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-13
Primary Completion
2017-04-03
Completion
2017-04-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01898013 on ClinicalTrials.gov