Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Opioid-use Disorder Clinical Trial

Official title: Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Status Terminated

Clinical Trial Summary

The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX. There will be three different methods of XR-NTX induction using increasing doses of oral naltrexone and buprenophine.

Clinical Trial Description

Procedure 1: 5-day induction with increasing doses of oral naltrexone. Participants will receive XR-NTX on day five together with buprenorphine, and will continue receiving buprenorphine for 4 weeks until they receive 2nd XR-NTX dose.

Procedure 2: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. No buprenorphine will be given beyond day 10.

Procedure 3: 10-day induction with buprenorphine administered daily and increasing daily doses of oral naltrexone beginning on day 2 . On day 10 participants will receive XR-NTX dose, and another one 4 weeks later. Buprenorphine will continue for 4 weeks until the 2nd XR-NTX dose.

All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication. ;

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

• NCT number: NCT03113409
• Study type: Interventional
• Source: New York State Psychiatric Institute
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 1, 2017
• Completion date: December 1, 2020