Overview

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