Phase 3
Completed N=38
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
Opiate Dependence
Source: ClinicalTrials.gov NCT00834080 ↗
Enrolled (actual)
38
Serious AEs
5.3%
Results posted
Jul 2013
Primary outcomePrimary: Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. — 37 participants
Summary
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. |
37 | — |
Eligibility Criteria
Primary Inclusion Criteria:
- Health care professional (eg, physician, osteopath, nurse, pharmacist)
- 18 years of age or older
- Enrolled or enrolling in an extended outpatient treatment program for opioid dependence
- Women of childbearing potential must agree to use an approved method of contraception for the duration of the study
Primary Exclusion Criteria:
- Pregnancy and/or lactation
- Evidence of hepatic failure
- Active hepatitis
- Any psychiatric disorder that would compromise ability to complete study requirements
- Recent history of suicidal ideation or attempt
- Current dependence to any drugs other than prescription opioids or heroin, benzodiazepines, caffeine, marijuana, alcohol, or nicotine
- Positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at screening
Data sourced from ClinicalTrials.gov (NCT00834080). 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. Informational only — not medical advice.