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

> **NCT01218984** · PHASE2 · COMPLETED · sponsor: **Alkermes, Inc.** · enrollment: 27 (actual)

## Conditions studied

- Opiate Dependence

## Interventions

- **DRUG:** 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

## Key facts

- **NCT ID:** NCT01218984
- **Lead sponsor:** Alkermes, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2002-03
- **Primary completion:** 2003-05
- **Final completion:** 2003-05
- **Target enrollment:** 27 (ACTUAL)
- **Last updated:** 2017-01-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01218984

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01218984, "ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01218984. Licensed CC0.

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