NCT03113409

Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Buprenorphine	Buprenorphine will be administered daily
DRUG	Naltrexone	On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX
DRUG	Vivitrol	Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2017-04-13
• Last updated: 2022-03-02
• Results posted: 2022-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study