NCT01218984

ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids

A Randomized, Single-Dose Opiate Challenge Study of Medisorb® Naltrexone in Opioid-Using Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults to assess the presence, duration, and degree of opiate blockade as well as the safety and tolerability of Medisorb® naltrexone (VIVITROL®). Subjects were randomized in a 1:1:1 ratio to receive a single gluteal intramuscular (IM) injection of Medisorb naltrexone 75, 150, or 300 mg.

Detailed description

Potential subjects were screened within 21 days prior to dosing of study drug (Medisorb naltrexone or placebo) on Day 0. Screening evaluations included a baseline hydromorphone challenge session in which increasing doses of hydromorphone (0 mg \[placebo\], 3 mg, 4.5 mg, and 6 mg) were administered at hourly intervals to produce a cumulative dose-response curve. Throughout the 4-hour challenge period, subject-rated measures (Visual Analog Scale \[VAS\] questions) and physiological measures (ie, pupil size) were recorded. As a safety measure, at least 7 days after the baseline hydromorphone challenge, a naloxone challenge was performed followed by a 1-day oral naltrexone tolerability assessment. On Day 0, eligible subjects were administered a single dose of study drug. To assess the level of opiate blockade and surmountability attributable to Medisorb naltrexone, experimental hydromorphone challenge sessions were conducted postdose at Days 7, 14, 21, 28, 42, and 56, with a single placebo hydromorphone challenge administered at a randomly selected visit. Pupil size was measured 15 minutes prior to the first hydromorphone dose and at 15, 30, 45, and minutes after each ascending hydromorphone/placebo for hydromorphone dose. Blood samples for measurement of naltrexone and 6B-naltrexol were obtained at screening and before hydromorphone/placebo administration on Days 7, 14, 21, 28, 42, and 56. Subjects were monitored for safety through Day 56.

Conditions

• Opiate Dependence

Interventions

Type	Name	Description
DRUG	Medisorb naltrexone 75 mg	Single administration via intramuscular (IM) injection.
DRUG	Medisorb naltrexone 150 mg	Single administration via IM injection.
DRUG	Medisorb naltrexone 300 mg	Single administration via IM injection.
DRUG	Hydromorphone (10 mg/mL)	Increasing doses of 0, 3, 4.5, and 6 mg were administered at baseline (pre-study drug administration). After study drug administration, additional hydromorphone challenge sessions consisting of administering 0, 3, 4.5, and 6 mg were administered at 1-hr intervals at each of the postdose evaluation visits. In addition, at a randomly selected evaluation visit, subjects received four 0 mg (placebo) doses at 1-hour intervals.
DRUG	Naloxone Challenge and Oral Naltrexone Tolerability Testing	Administered according to the instructions provided by the respective manufacturer. Testing occurred at least 7 days after the baseline hydromorphone challenge and prior to study drug administration.

Timeline

• Start date: 2002-03-01
• Primary completion: 2003-05-01
• Completion: 2003-05-01
• First posted: 2010-10-13
• Last updated: 2017-01-11
• Results posted: 2010-12-13