Status:
WITHDRAWN
Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone
Lead Sponsor:
The Cleveland Clinic
Conditions:
Substance Use Disorders
Substance Abuse
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This is an open-label, single center study of The Bridge in patients with sustained remission of opiate dependence on established, low-dose MAT with buprenorphine. A fixed number of patients will be a...
Detailed Description
This is an open-label, single center study of The Bridge in patients with sustained remission of opiate dependence on established, low-dose MAT with buprenorphine. A fixed number of patients will be a...
Eligibility Criteria
Inclusion
- Diagnosis of opiate use disorder, any severity
- Age range 18-99 years old
- Not pregnant or breastfeeding
- Able to understand and provide informed consent.
- Able to understand and speak the English language.
- At least one year of abstinence from drugs of abuse including, but not limited to, all opiates, cannabis, benzodiazepines, barbiturates, alcohol and cocaine.
- Use of nicotine is excluded from this criterion.
- Use of any prescribed, controlled substance, taken according to the prescribing instructions, for no more than seven consecutive days, at least three months prior to the subject's study enrollment, is excluded from this criterion.
- Taking dose of buprenorphine less than or equal to no more than 4 mg daily for at least three months prior to starting the study.
- In the case of Zubsolv rapid-dissolve tablets, equivalent daily dose maximum would be 2.9mg.
- In the case of Bunavail buccal film, equivalent daily dose maximum would be 2.1mg.
- At least one year of self-reported, established 12-step based recovery work, including
- Home group membership and regular attendance of two 12- step meetings per week
- Regular work with 12-step sponsor who can attest that the subject has worked through step nine of the twelve steps of Alcoholics Anonymous or a similar 12-step based mutual help organization.
Exclusion
- Exhibits active psychosis or suicide ideation or is otherwise psychiatrically unstable.
- Positive Utox2 Immunoassay, Quantitative Pain Panel Liquid Chromatography/Mass Spectroscopy, or Ethylglucuronide test for any nonprescribed substance or medication.
- Meets criteria for any other active substance use disorder except nicotine
- Allergic to naltrexone or has any condition of such nature and/or severity that would clinically contraindicate the prescribing of naltrexone.
- Any condition that contraindicates the use of NSS-2 including hemophilia, cardiac pacemakers and psoriasis vulgaris.
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03762798
Start Date
November 19 2018
End Date
December 1 2020
Last Update
September 23 2021
Active Locations (1)
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1
Cleveland Clinic Lutheran Hospital
Cleveland, Ohio, United States, 44113