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

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Analgesics, Opioid; Hydromorphone; Naloxone; Naltrexone

Criteria

Primary Inclusion Criteria:

• Adults who had used opioids: non-medically for at least 1 year; at least once per week for at least some period during their use history; and fewer than 3 times per week on average for the 30 days prior to screening.

• Provided written informed consent

• Demonstrated a positive response to hydromorphone challenge during screening

• Willing to use contraception for study duration if of childbearing potential

Primary Exclusion Criteria:

• Any clinically significant medical condition or laboratory abnormality at screening

• Participated in a clinical trial within prior 30 days

• Dependent on opioids

• Seeking treatment for opioid abuse

• Psychosis or any major mood or anxiety disorder

• Pregnancy or lactation