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CompletedNCT01453374Updated Jul 13, 2015Results posted

A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration

A Phase 4 interventional study of VIVITROL 380mg in Opioid Dependence, sponsored by Alkermes, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-13.

Sponsored by Alkermes, Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

This is an open-label study with a pre-post design. Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (three for men and one for women) will receive 1 injection of VIVITROL prior to release from prison and will be offered 6 monthly injections of VIVITROL for 6 months post release. Subjects will complete follow-up visits 1 and 2 months after the last VIVITROL injection. Subjects will be assessed at 10 time points, and adherence to VIVITROL, both in prison and in the community, will be assessed.

02

Conditions studied

  • Opioid Dependence

Keywords

  • opioid dependence
  • VIVITROL
  • criminal justice
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 27 is below the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Alkermes, Inc. is the lead sponsor of 82 studies on the registry; 8 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    VIVITROL

    380 mg IM injection

    Drug: VIVITROL 380mg

Interventions

  • DrugVIVITROL 380mg

    380 mg IM injection given once monthly

06

What researchers measure

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.

    Time frame: 7 months

Secondary outcomes

  1. Incidence of Subject Re-incarceration

    Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report.

    Time frame: 7 months

  2. Opioid Use

    Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.

    Time frame: 7 months

  3. Opioid Overdose

    Number of subjects who overdosed during the study; measured through reported AEs of "overdose" and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times.

    Time frame: 7 months

  4. Drug Abuse Treatment Program Entry

    Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.

    Time frame: 7 months

  5. Retention in the Community

    Number of subjects who received all 6 post-release VIVITROL injections

    Time frame: 6 months

  6. Opioid Craving

    Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever.

    Time frame: 8 months

  7. Opioid Dependence

    Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence

    Time frame: 7 months

  8. Cocaine Use

    Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests

    Time frame: 6 months

  9. Criminal Activity

    Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires

    Time frame: 6 months

07

Results

Posted Jul 13, 2015
Limitations and caveats
The outcome measure of opioid dependence was not analyzed.

Participant flow

Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (3 for men and 1 for women) received 1 injection of VIVITROL prior to release from prison and were offered 6 monthly injections of VIVITROL after release from prison, for a total of 7 injections.

Participant flow — Overall Study
MilestoneVIVITROL
Started27
Completed9
Not completed18
Withdrew: Adverse event7
Withdrew: Lack of efficacy1
Withdrew: Lost to follow-up3
Withdrew: Withdrawal by subject5
Withdrew: Incarcerated2

Outcome measures

PrimaryIncidence 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.

Time frame:
7 months
Reported as:
Number · participants re-arrested
Incidence of Subject Re-arrest
participants re-arrested<7 InjectionsAll 7 Injections
Incidence of Subject Re-arrest62
Statistical analysis
  • <7 Injections vs All 7 Injections · Fisher Exact · p = >0.05
SecondaryIncidence of Subject Re-incarceration

Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report.

Time frame:
7 months
Reported as:
Number · participants re-incarcerated
Incidence of Subject Re-incarceration
participants re-incarcerated<7 InjectionsAll 7 Injections
Incidence of Subject Re-incarceration52
Statistical analysis
  • <7 Injections vs All 7 Injections · Fisher Exact · p = >0.05
SecondaryOpioid Use

Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.

Time frame:
7 months
Reported as:
Number · participants with positive opioid use
Opioid Use
participants with positive opioid use<7 InjectionsAll 7 Injections
Opioid Use112
Statistical analysis
  • <7 Injections vs All 7 Injections · Fisher Exact · p = <0.05
SecondaryOpioid Overdose

Number of subjects who overdosed during the study; measured through reported AEs of "overdose" and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times.

Time frame:
7 months
Reported as:
Number · participants who overdosed
Opioid Overdose
participants who overdosedVIVITROL
Opioid Overdose1
SecondaryDrug Abuse Treatment Program Entry

Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.

Time frame:
7 months
Reported as:
Number · participants who entered drug treatment
Drug Abuse Treatment Program Entry
participants who entered drug treatmentVIVITROL
Drug Abuse Treatment Program Entry24
SecondaryRetention in the Community

Number of subjects who received all 6 post-release VIVITROL injections

Time frame:
6 months
Reported as:
Number · participants received all 7 injections
Retention in the Community
participants received all 7 injectionsVIVITROL
Retention in the Community10
SecondaryOpioid Craving

Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever.

Time frame:
8 months
Reported as:
Mean · units on a scale
Opioid Craving
units on a scaleVIVITROL
Actual Value21.0 ± 33.4
Change from Baseline-11.0 ± 47.4
SecondaryOpioid Dependence

Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence

Time frame:
7 months

Results for this outcome have not been posted.

SecondaryCocaine Use

Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests

Time frame:
6 months
Reported as:
Number · participants who used cocaine
Cocaine Use
participants who used cocaine<7 InjectionsAll 7 Injections
Cocaine Use50
Statistical analysis
  • <7 Injections vs All 7 Injections · Fisher Exact · p = <0.10
SecondaryCriminal Activity

Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires

Time frame:
6 months
Reported as:
Number · participants with criminal activity
Criminal Activity
participants with criminal activityVIVITROL
Criminal Activity18

Adverse events

Collected over Data were collected during a 9-month time frame. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VIVITROL—6/27 (22.2%)26/27 (96.3%)
Most frequent serious events
Most frequent serious events
EventVIVITROL
Anaphylactic reactionImmune system disorders1/27
HypersensitivityImmune system disorders1/27
Abscess limbInfections and infestations1/27
DepressionPsychiatric disorders1/27
Psychotic disorderPsychiatric disorders1/27
Schizophrenia, paranoid typePsychiatric disorders1/27
CellulitisSkin and subcutaneous tissue disorders1/27
Most frequent other events
Showing 10 of 52
Most frequent other events
EventVIVITROL
NasopharyngitisRespiratory, thoracic and mediastinal disorders12/27
HypertensionVascular disorders11/27
DepressionPsychiatric disorders8/27
NauseaGastrointestinal disorders7/27
Blood glucose increasedInvestigations5/27
Platelet count increasedInvestigations5/27
HeadacheNervous system disorders5/27
LymphadenopathyBlood and lymphatic system disorders4/27
Abdominal pain upperGastrointestinal disorders4/27
Oedema peripheralGeneral disorders4/27

Baseline characteristics

All subjects who received at least 1 injection of VIVITROL

Age, Categorical
Age, Categorical(Participants)VIVITROL
<=18 years0
Between 18 and 65 years27
>=65 years0
Age, Continuous
Age, Continuous(Years)VIVITROL
Mean39.9 ± 8.3
Sex: Female, Male
Sex: Female, Male(Participants)VIVITROL
Female11
Male16
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)VIVITROL
Hispanic or Latino0
Not Hispanic or Latino27
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VIVITROL
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American23
White4
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)VIVITROL
United States27
08

Study locations

1 site
  • Friends Research Institute
    Baltimore, Maryland 21201, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01453374
Lead sponsor
Alkermes, Inc.
Responsible party
Sponsor
First posted
Oct 17, 2011
Start date
Jan 2011
Primary completion
May 2014
Completion
May 2014
Results posted
Jul 13, 2015
Last update
Jul 13, 2015

Study contacts

Bernard L Silverman, MD
study director · Alkermes, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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