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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Buprenorphine will be administered daily
On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX
Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
New York State Psychiatric Institute
New York, New York, United States
Percentage of Patients Who Receive the Second Injection of XR-NTX.
Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX
Time frame: 4 weeks after 1st injection
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