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

NCT01218984 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-01-11

Study results available
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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.

Conditions

  • Opiate Dependence

Interventions

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.

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Bernard L. Silverman, MD · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2003-05-31
Completion
2003-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218984 on ClinicalTrials.gov