ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

Alkermes

Status and phase

Completed

Phase 3

Conditions

Opiate Dependence

Treatments

Drug: VIVITROL® 380 mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00678418

ALK21-013

Details and patient eligibility

About

This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid dependence.

The study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has completed. Results for Part B are not yet available.

Full description

Part A was a double-blind, randomized, placebo-controlled assessment of the efficacy and safety of 24 weeks of monthly treatment with VIVITROL compared to placebo in opioid-dependent adults.

Subjects who completed Part A could choose to continue to Part B, which was an open-label extension to assess longer-term safety, durability of effect, health economics, and quality of life (QOL) in the continuing study population for up to 1 year.

At the conclusion of both parts, each completing subject will have received a total of up to 19 injections of study drug over approximately 1.5 years.

Dosing was performed by the principal investigator or designated study staff member.

All subjects received standardized, manual-based psychosocial support at each scheduled visit. Opioid use was tracked through urine drug testing and subjects' self reports. Other evaluations for efficacy and safety, health economics, and quality of life were routinely conducted throughout the study.

Enrollment

250 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Primary Inclusion Criteria:

Written, informed consent
18 years of age or older
Current diagnosis of opioid dependence, based on Diagnostic and Statistical Manual of Mental Health Disorders, 4th Ed. (DSM-IV-TR) criteria
Voluntarily seeking treatment for opioid dependence
Completing or recently completed up to 30 days of inpatient treatment for opioid detoxification, and off all opioids (including buprenorphine and methadone) for at least 7 days
Noncustodial, stable residence and phone, plus 1 contact with verifiable address and phone
Significant other (eg, spouse, relative) willing to supervise compliance with the study visit schedule and procedures
Agree to use contraception for study duration if of childbearing potential

Primary Exclusion Criteria:

Pregnancy or lactation
Clinically significant medical condition or observed abnormalities (eg: physical exam, electrocardiogram (ECG), lab and/or urinalysis findings)
Positive naloxone challenge test at randomization (Day 0)
Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of normal (ULN) and/or esophageal variceal disease
Past or present history of an acquired immunodeficiency syndrome (AIDS)-indicator disease in HIV-infected subjects
Active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase(ALT) >3xULN
Current major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise ability to complete the study
Recent history (within 6 months prior to screening) of suicidal ideation or attempt
Dependence within prior year based on DSM-IV-TR, to any drugs other than prescription opioids or heroin, caffeine, marijuana, or nicotine
Active alcohol dependence within prior 6 months
Current alcohol use disorder that would, in the Investigator's opinion, preclude successful completion of the study
Positive urine drug test for cocaine, benzodiazepines, or amphetamines at screening
Use of oral naltrexone for 7 consecutive days within 60 days prior to screening
Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)