The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment. Importantly, medical devices reviewed by the FDA are cleared (based on safety) rather than approved (based on efficacy), which means the BD did not need to demonstrate efficacy before it became commercially available. As a result, the device was not required to have a sham-controlled trial for FDA clearance and there is no active research, to the investigators' knowledge, that specifically addresses the degree to which opioid withdrawal can be treated through neuromodulation. To rigorously evaluate the efficacy of the BD for treating OUD, the investigators will enroll persons with active OUD, not currently receiving medications for OUD. Participants will be recruited and admitted to the Clinical Research Unit (CRU) for a 2-3 week period. During participants' residential stay, participants will be stabilized for 7-11 days on four times daily morphine (30 mg, SC) and undergo a precipitated withdrawal challenge using the opioid antagonist naloxone, approximately \>= 4 days of morphine maintenance. This is a standard practice for the investigators' study and allows the investigators to objectively assess dependence. The BD and study medication will begin following morphine stabilization. Participants will be randomly assigned to one of three conditions (1) active BD with placebo (BD/P), (2) sham BD with lofexidine (SBD/L), or (3) sham BD and placebo (SBD/P). Participants will use the BD for 5 days and will receive study drug for 7 days. Participants will be monitored for an additional 4 days after device removal to determine whether withdrawal resumes. Participants will undergo a second naloxone challenge after removal of the device/capsule completion to verify lack of opioid tolerance and will be encouraged to begin treatment with oral naltrexone followed by extended release naltrexone. Throughout the residential stay, all participants will be given referral to and assisted with engaging in outpatient treatment following study discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
An FDA-cleared neuromodulator medical device, marketed for the treatment of opioid withdrawal
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.
Inactive study drug, encapsulated to look like the active study drug. Participants will receive capsules 4 times daily for 7 days.
Inactive Bridge Device which is applied and looks identical to the active Bridge Device
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States
Proportion of participants retained
The proportion of participants who are retained (dichotomous: retained, not retained) during the 5 day intervention. Greater retention is indicative of a better treatment outcome.
Time frame: Up to 5 days
Withdrawal Severity as measured by Clinical Opiate Withdrawal Scale (COWS) peak score
Peak COWS Score (range: 0-48). Lower peak COWS scores are indicative of better withdrawal suppression.
Time frame: At the end of day 5
Withdrawal Severity as measured by area under the curve COWS score
Area under the curve COWS scores (range: 0-240). Smaller area under the curve COWS scores are indicative of better withdrawal suppression.
Time frame: At the end of day 5
Withdrawal Severity as measured by COWS peak daily score
Peak daily COWS score (range: 0-48). Lower peak daily COWS scores are indicative of better withdrawal suppression.
Time frame: Up to 5 days
Proportion of participants retained
The proportion of participants who are retained (dichotomous: retained, not retained) during the 9 day intervention. Greater retention is indicative of better intervention outcome.
Time frame: At the end of day 9
Withdrawal severity as measured by the Subjective Opiate Withdrawal Scale (SOWS) peak score
Peak SOWS Score (range: 0-64). Lower peak SOWS scores are indicative of better withdrawal suppression.
Time frame: At the end of day 5
Withdrawal severity as measured by area under the curve SOWS score
Area under the curve SOWS scores (range: 0-320). Smaller area under the curve SOWS scores are indicative of better withdrawal suppression.
Time frame: At the end of day 5
Withdrawal severity as measured by the SOWS peak daily score
Peak daily SOWS score (range: 0-64). Lower peak daily SOWS scores are indicative of better withdrawal suppression.
Time frame: Up to 5 days
Proportion of Participants who initiate naltrexone at the end of the study
The proportion of participants who initiate naltrexone (dichotomous: yes, no) at the end of day 9. A larger proportion of participants is indicative of better naltrexone initiation success.
Time frame: At the end of day 9
Number of concomitant medications used
Number of concomitant medications used per day. A smaller number of concomitant medications used per day is indicative of better treatment efficacy.
Time frame: Up to 5 days
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