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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00834080
Other study ID # ALK21-021
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2009
Est. completion date May 2012

Study information

Verified date November 2018
Source Alkermes, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Medisorb naltrexone 380 mg
Intramuscular (IM) injection administered once every 4 weeks for up to 2 years

Locations

Country Name City State
United States Alkermes Clinical Study Site Austin Texas
United States Alkermes Clinical Study Site Canton Ohio
United States Alkermes Clinical Study Site Colton California
United States Alkermes Clinical Study Site Dallas Texas
United States Alkermes Clinical Study Site Elmsford New York
United States Alkermes Clinical Study Site Hoffman Estates Illinois
United States Alkermes Clinical Study Site Lauderhill Florida
United States Alkermes Clinical Study Site Oceanside California
United States Alkermes Clinical Study Site Philadelphia Pennsylvania
United States Alkermes Clinical Study Site Philadelphia Pennsylvania
United States Alkermes Clinical Study Site Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Earley PH, Zummo J, Memisoglu A, Silverman BL, Gastfriend DR. Open-label Study of Injectable Extended-release Naltrexone (XR-NTX) in Healthcare Professionals With Opioid Dependence. J Addict Med. 2017 May/Jun;11(3):224-230. doi: 10.1097/ADM.00000000000003 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period). 2 years (Baseline to end of study)
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