Opioid DependencePhase 4NCT01453374
A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
A Phase 4 study testing VIVITROL 380mg in people with Opioid Dependence, run by Alkermes, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- VIVITROL 380mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Friends Research Institute
Baltimore, Maryland, 21201
About this study
Official title: A Phase 4, Pilot, Open-label Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
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.
- Conditions
- Opioid Dependence
- Being tested
- VIVITROL 380mg
- Keywords
- opioid dependence, VIVITROL, criminal justice
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVITROL 380mgDrug
380 mg IM injection given once monthly
| Study group | Role | What they receive |
|---|---|---|
| VIVITROL | Experimental | 380 mg IM injection Receives: Drug: VIVITROL 380mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Secondary outcomes (9)
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.
Measured: 7 months
Opioid Use
Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.
Measured: 7 months
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.
Measured: 7 months
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.
Measured: 7 months
Retention in the Community
Number of subjects who received all 6 post-release VIVITROL injections
Measured: 6 months
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.
Measured: 8 months
Opioid Dependence
Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence
Measured: 7 months
Cocaine Use
Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard L Silverman, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453374
- Sponsor's protocol ID
- ALK21-028
- Status last verified
- Jun 2015
- First submitted
- 13 Oct 2011
- Last updated
- 13 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Pilot, Open-label Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
- ClinicalTrials.gov ID
- NCT01453374
- Acronym / sponsor ID
- ALK21-028
- Conditions
- Opioid Dependence
- Keywords
- opioid dependence, VIVITROL, criminal justice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Posted 13 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIVITROL | Experimental | Drug: VIVITROL 380mg380 mg IM injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIVITROL 380mg380 mg IM injection given once monthly | Drug | VIVITROL |
Primary outcome
Incidence of Subject Re-arrest
Time frame: 7 months
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.
9 secondary outcomes
Incidence of Subject Re-incarceration
Time frame: 7 months
Opioid Use
Time frame: 7 months
Opioid Overdose
Time frame: 7 months
Drug Abuse Treatment Program Entry
Time frame: 7 months
Retention in the Community
Time frame: 6 months
Opioid Craving
Time frame: 8 months
Opioid Dependence
Time frame: 7 months
Cocaine Use
Time frame: 6 months
Criminal Activity
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard L Silverman, MD study director
Alkermes, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VIVITROL 380mg in people with Opioid Dependence, run by Alkermes, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Subject Re-arrest (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015.