Phase 2
N=27
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
Opiate Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01218984 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Slope Change From Baseline for Pupil Size — -0.5540; -0.3607; -0.1410 cm(2)/hr
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Medisorb naltrexone 75 mg (Drug); Medisorb naltrexone 150 mg (Drug); Medisorb naltrexone 300 mg (Drug); Hydromorphone (10 mg/mL) (Drug); Naloxone Challenge and Oral Naltrexone Tolerability Testing (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Alkermes, Inc.
- Primary completion
- May 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Slope Change From Baseline for Pupil Size |
-0.5540; -0.3607; -0.1410 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01218984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.