common.study.topics.clinical

BRIDGE Device for Treatment of Opioid Withdrawal

common.study.values.description

BRIDGE Device for Treatment of Opioid Withdrawal

The purpose of this study is to prospectively evaluate the effectiveness of the NSS-2 BRIDGE device in reducing the signs and symptoms of acute opioid withdrawal when compared to placebo.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Device - Active BRIDGE device placement

The active BRIDGE device will be placed by a blinded medical provider. The severity of opioid withdrawal signs and symptoms will be assessed with the COWS, pain and cognitive functioning tests at several time points. Patients will be dosed with buprenorphine at the blinded provider's discretion. Supportive medications to help manage signs and symptoms of opioid withdrawal will NOT be allowed for one hour after the first dose of buprenorphine. Subjects will be asked to return to clinic for additi ...read more on ClinicalTrials.org

Device - Inactive BRIDGE device placement

The inactive or sham BRIDGE device will be placed by a blinded medical provider. The severity of opioid withdrawal signs and symptoms will be assessed with the COWS, pain and cognitive functioning tests at several time points. Patients will be dosed with buprenorphine at the blinded provider's discretion. Supportive medications to help manage signs and symptoms of opioid withdrawal will NOT be allowed for one hour after the first dose of buprenorphine. Subjects will be asked to return to clinic ...read more on ClinicalTrials.org

participant.views.study.view.additional

participant.views.study.view.scientific-title

BRIDGE Device for Symptoms of Opioid Withdrawal: A Randomized, Double-Blind, Placebo-Controlled Study

common.study.values.clinical-trial-id

NCT04162145

participant.views.study.view.id

b68O9e