An Innovative Intervention for OUD Treatment

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

November 15, 2020

Primary Completion Date

April 20, 2025

Study Completion Date

January 1, 2026

Conditions
Opioid-Related DisordersOpioid DependenceOpioid AddictionOpioid Withdrawal
Interventions
DEVICE

Bridge Device

An FDA-cleared neuromodulator medical device, marketed for the treatment of opioid withdrawal

DRUG

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.

DRUG

Placebo

Inactive study drug, encapsulated to look like the active study drug. Participants will receive capsules 4 times daily for 7 days.

DEVICE

Sham Bridge Device

Inactive Bridge Device which is applied and looks identical to the active Bridge Device

Trial Locations (1)

21224

RECRUITING

Behavioral Pharmacology Research Unit, Baltimore

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Johns Hopkins University

OTHER