NCT01453374

Brief Summary

This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 13, 2015

Completed
Last Updated

July 13, 2015

Status Verified

June 1, 2015

Enrollment Period

3.3 years

First QC Date

October 13, 2011

Results QC Date

May 21, 2015

Last Update Submit

June 19, 2015

Conditions

Opioid Dependence

Keywords

opioid dependenceVIVITROLcriminal justice

Outcome Measures

Primary Outcomes (1)

  • Incidence of Subject Re-arrest

    Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report.

    7 months

Secondary Outcomes (9)

  • Incidence of Subject Re-incarceration

    7 months

  • Opioid Use

    7 months

  • Opioid Overdose

    7 months

  • Drug Abuse Treatment Program Entry

    7 months

  • Retention in the Community

    6 months

  • +4 more secondary outcomes

Study Arms (1)

VIVITROL

EXPERIMENTAL

380 mg IM injection

Drug: VIVITROL 380mg

Interventions

VIVITROL 380mgDRUG

380 mg IM injection given once monthly

VIVITROL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friends Research Institute

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

vivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Limitations and Caveats

The outcome measure of opioid dependence was not analyzed.

Results Point of Contact

Title
Bernard L. Silverman, MD
Organization
Alkermes
Bernard.Silverman@alkermes.com
781-609-6000

Study Officials

  • Bernard L Silverman, MD

    Alkermes, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 17, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 13, 2015

Results First Posted

July 13, 2015

Record last verified: 2015-06

Locations

US(1)