160
Participants
Start Date
January 15, 2024
Primary Completion Date
August 16, 2025
Study Completion Date
August 16, 2025
Low-Dose Naltrexone
"Study drug dosing schedule (LDN):~* Week 1: 1 mg/day (1 mg cap)~* Week 2: 2 mg/day (two 1 mg caps)~* Week 3: 3 mg/day (three 1mg caps)~* Weeks 4-6: 4.5 mg/day (three 1 mg caps, plus one 1.5 mg cap = 4.5 mg/day)~* Weeks 7-16: 4.5 mg/day (one 4.5 mg cap) OR based on self-titration dosage (one 1mg, 2mg, or 3mg cap)"
Placebo
"Study drug dosing schedule (Placebo; capsules made to match LDN doses):~* Week 1: 1 mg/day (1 mg cap)~* Week 2: 2 mg/day (two 1 mg caps)~* Week 3: 3 mg/day (three 1mg caps)~* Weeks 4-6: 4.5 mg/day (three 1 mg caps, plus one 1.5 mg cap = 4.5 mg/day)~* Weeks 7-16: 4.5 mg/day (one 4.5 mg cap) OR based on self-titration dosage (one 1mg, 2mg, or 3mg cap)"
RECRUITING
Women's Health Research Institute, Vancouver
University of British Columbia
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Provincial Health Services Authority
OTHER
Women's Health Research Institute of British Columbia
OTHER
Luis Nacul
OTHER