Phase 4
Completed N=27
A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Source: ClinicalTrials.gov NCT01453374 ↗Enrolled (actual)
27
Serious AEs
22.2%
Results posted
Jul 2015
Primary outcomePrimary: Incidence of Subject Re-arrest — 6; 2 participants re-arrested — p=>0.05
Summary
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Subject Re-arrest |
6; 2 | >0.05 |
| SECONDARY Incidence of Subject Re-incarceration |
5; 2 | >0.05 |
| SECONDARY Opioid Use |
11; 2 | <0.05 sig |
| SECONDARY Opioid Overdose |
1 | — |
| SECONDARY Drug Abuse Treatment Program Entry |
24 | — |
| SECONDARY Retention in the Community |
10 | — |
| SECONDARY Opioid Craving |
21.0; -11.0 | — |
| SECONDARY Opioid Dependence |
— | — |
| SECONDARY Cocaine Use |
5; 0 | <0.10 |
| SECONDARY Criminal Activity |
18 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Pregnancy and/or breastfeeding
- Clinically significant active medical condition
- Active hepatitis
- 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
Data sourced from ClinicalTrials.gov (NCT01453374). 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.