Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)

Alkermes

Status and phase: Completed; Phase 3

Conditions: Opioid Use Disorder

Treatments: Drug: NTX/PBO-B; Drug: NTX/BUP; Drug: PBO-N/PBO-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02537574

ALK6428-A301

Details and patient eligibility

About

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.

Enrollment: 380 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide informed consent
• Willing and able to provide government-issued identification
• Has a BMI of 18.0-40.0 kg/m^2
• Has a physiologic dependence on opioids
• Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
• Wiling to abide by the contraception requirements for the duration of the study
• Additional criteria may apply

Exclusion criteria

• Is pregnant, planning to become pregnant or breastfeeding during the study
• Has used Buprenorphine within 7 days prior to randomization
• Has used Methadone within 14 days prior to randomization
• Has a history of VIVITROL use within 90 days prior to screening or has used oral naltrexone within 14 days prior to randomization
• Has a history of seizures or has received anticonvulsant therapy within the past 5 years
• Has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments
• Has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder
• Is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification
• Has a history of hypersensitivity or adverse reaction to Buprenorphine, Naltrexone, or Naloxone
• Has a history of more than 3 unsuccessful inpatient or medically assisted outpatient opioid detoxifications during his/her lifetime
• Has significant suicidal ideation or behavior within the past year
• Is currently participating, or has participated, in a clinical trial of an investigational drug, device, or biologics within 3 months prior to screening
• Has a history of accidental opioid drug overdose in the past 3 years whether or not medical treatment was sought or received
• Is court mandated to receive treatment for opioid use disorder
• Additional criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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380 participants in 3 patient groups, including a placebo group

NTX/BUP

Experimental group

Description:

Oral naltrexone + sublingual buprenorphine

Treatment:

Drug: NTX/BUP

NTX/PBO-B

Active Comparator group

Description:

Oral naltrexone + sublingual placebo

Treatment:

Drug: NTX/PBO-B

PBO-N/PBO-B

Placebo Comparator group

Description:

Oral placebo naltrexone + sublingual placebo buprenorphine

Treatment:

Drug: PBO-N/PBO-B