This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison
and continuing VIVITROL upon release into the community.
Drug: VIVITROL 380mg
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01453374
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Not currently addicted to opioids, but has a diagnosis of pre-incarceration opioid dependence
Inmate at the Metropolitan Transition Center (Baltimore, MD), Maryland Correctional Institute for Women (Jessup, MD), Baltimore Pre-Release Unit (Baltimore, MD), or Jessup Pre-Release Unit (Jessup, MD) and eligible for release within 30 days of screening
Expressing a goal of opiate-free treatment upon release
Currently opioid free
Planning to live in the Baltimore, MD area for at least 8 months following prison release
Pregnancy and/or breastfeeding
Clinically significant active medical condition
Past or present history of an AIDS-indicator disease in subjects who are infected with HIV
Any untreated or unstable psychiatric disorder(eg, bipolar with mania)
Recent suicidal ideation
Current chronic pain diagnosis for which opioids are prescribed
Positive drug test for opioids
History of drug overdose within the past 3 years requiring inpatient hospitalization
All locations for NCT01453374
United States (1)
Friends Research Institute
Baltimore, Maryland, United States, 21201
Trial results for NCT01453374
Participant Flow: Overall Study
9 / 27
Completed / Started
Serious Adverse Events
6 / 27
Affected / At Risk
Other Adverse Events
26 / 27
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT01453374. The sponsor of the trial is Alkermes, Inc. and it is looking for 27 volunteers for the current phase.
Official trial title: A Phase 4, Pilot, Open-label Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
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