Conditions: Opioid Use Disorder
Keywords: Alkermes Buprenorphine Naltrexone Vivitrol Opioid Use Opiates Dependence Abuse Heroin Painkillers Substance Abuse
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 380
Healthy volunteers: no

Brief summary:
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.

Detailed description:

Arms:
arm 1: Oral naltrexone + sublingual buprenorphine arm 2: Oral naltrexone + sublingual placebo arm 3: Oral placebo naltrexone + sublingual placebo buprenorphine

Interventions: intervention 1: NTX/BUP intervention 2: NTX/PBO-B intervention 3: PBO-N/PBO-B
Intervention descriptions: intervention 1: Daily doses intervention 2: Daily doses intervention 3: Daily doses

Protocol document: