Status:
COMPLETED
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
Lead Sponsor:
Alkermes, Inc.
Conditions:
Opiate Dependence
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief 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 M...
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 wh...
Eligibility Criteria
Inclusion
- Primary
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2003
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01218984
Start Date
March 1 2002
End Date
May 1 2003
Last Update
January 11 2017
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