Trial Outcomes & Findings for Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol (NCT NCT03113409)

NCT ID: NCT03113409

Last Updated: 2022-03-02

Results Overview

Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: 4 weeks after 1st injection
• Results posted on: 2022-03-02

Participant Flow

Participant milestones

Measure	Procedure 1 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.	Procedure 2 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.	Procedure 3 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Overall Study STARTED	10	0	0
Overall Study COMPLETED	5	0	0
Overall Study NOT COMPLETED	5	0	0

Reasons for withdrawal

Measure	Procedure 1 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.	Procedure 2 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.	Procedure 3 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Overall Study Withdrawal by Subject	5	0	0

Baseline Characteristics

Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Baseline characteristics by cohort

Measure	Procedure 1 n=10 Participants 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34.5 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after 1st injection

Population: all participants enrolled in the study (Procedure 1)

Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX

Outcome measures

Measure

Procedure 1 n=10 Participants 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. Buprenorphine: Buprenorphine will be administered daily Naltrexone: On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX Vivitrol: Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.

Percentage of Patients Who Receive the Second Injection of XR-NTX.

6 Participants

Adverse Events

Procedure 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adam Bisaga MD

NYS Psychiatric Institute

Phone: 646-774-6155

Email: adam.bisaga@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place