Opiate Dependence Clinical Trial
Official title:
Open-Label Study of the Safety and Tolerability of VIVITROL Administered to Health Care Professionals Participating in an Extended Outpatient Treatment Program for Opioid Dependence
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 |
Verified date | November 2018 |
Source | Alkermes, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Alkermes, Inc. |
United States,
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
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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