75
Participants
Start Date
November 15, 2020
Primary Completion Date
April 20, 2025
Study Completion Date
January 1, 2026
Bridge Device
An FDA-cleared neuromodulator medical device, marketed for the treatment of opioid withdrawal
Lofexidine
FDA-approved medication for the treatment of opioid withdrawal. Participants will receive capsules 4 times daily for 7 days. The active dose is 0.72 mg four times daily for Days 1-5, for a total daily dose of 2.88 mg. Doses on Days 6 and 7 will be 1.44 (2 active, 2 placebo capsules) and 0.72 mg (1 active, 3 placebo capsules), respectively.
Placebo
Inactive study drug, encapsulated to look like the active study drug. Participants will receive capsules 4 times daily for 7 days.
Sham Bridge Device
Inactive Bridge Device which is applied and looks identical to the active Bridge Device
RECRUITING
Behavioral Pharmacology Research Unit, Baltimore
National Institutes of Health (NIH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
Johns Hopkins University
OTHER