Opiate Dependence Clinical Trial
Official title:
An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction
The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.
Thirty-five opioid dependent (OD) volunteers seeking treatment will be enrolled in an
open-label, flexible-dosing, outpatient trial at Duke Addictions Program. On days 1-4,
participants will receive buprenorphine/naloxone daily at a starting dose of between 4 to 8
mg, progressively decreasing to 2 mg on by day 4. Participants will also receive very low
dose naltrexone (VLNTX) at a dose of 0.25 mg on Days 1-3, 2.5 mg on Day 4 and between 10 and
50 mg on Days 5-7. Then a VIVITROL injection, 380 mg, will be administered on Day 8.
Evaluations will occur daily for up to 6 hours until 1 day after VIVITROL injection and then
weekly for 4 weeks. Patients will receive ancillary medications as needed and weekly
psychosocial intervention. At the end of the study, participants will be offered outpatient
treatment of OD at the study site, or will be referred to other treatment programs.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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