Opiate DependencePhase 3NCT01180647
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
A Phase 3 study testing Extended-Release Naltrexone and Motivational Enhancement Counseling in people with Opiate Dependence, run by NYU Langone Health at 2 sites in United States.
Trial summary
This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Extended-Release Naltrexone and Motivational Enhancement Counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Jul 2013
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults incarcerated in NYC jails with known release date
- DSM-IV criteria for current opioid dependence
- No current agonist (methadone, buprenorphine) treatment
- Currently opioid free by history ('detoxed') and with a negative urine for all opioids
- General good health as determined by complete medical interview and physical examination
- Age 18-60 years.
Who cannot join
- History of liver failure, cirrhosis, or recent liver function test levels greater than three times normal
- Pregnancy, lactation, or planning conception
- Active medical illness that might make participation hazardous
- Untreated psychiatric disorder
- History of allergic reaction to naltrexone, PLG (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent.
- Current chronic pain condition treated with opioids.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York University School of Medicine
New York, New York, 10016
New York City Department of Correction
New York, New York, 11370
About this study
This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.
Read the detailed description
This protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. All N=40 participants receive a two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be randomized to pre-release treatment with XR-NTX. Immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly lower rates of sustained opioid relapse following release.
- Conditions
- Opiate Dependence
- Being tested
- Extended-Release Naltrexone, Motivational Enhancement Counseling
- Keywords
- Extended-release naltrexone, Prisoners, Opioid addiction prevention, Medication Treatment Alternatives, Prevention of Relapse to Opioid Addiction
- 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.
Extended-Release NaltrexoneDrug
Also called Vivitrol
380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
Motivational Enhancement CounselingBehavioural
The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
| Study group | Role | What they receive |
|---|---|---|
| Extended-release naltrexone (XR-NTX) | Active comparator | A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection. Receives: Drug: Extended-Release Naltrexone |
| Motivational Enhancement Counseling Only | Placebo comparator | The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. Receives: Behavioral: Motivational Enhancement Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Release Opioid Relapse
Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.
Measured: Four weeks post-release
Secondary outcomes (5)
Participation in Community Drug Treatment Post-release
This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit.
Measured: Four weeks post-release
Any Opioid Use Post-release
Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release.
Measured: Four weeks post-release
Injection Drug Use Post-release
This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail.
Measured: Four weeks post-release
Accidental Drug Overdose
Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.
Measured: Four weeks post-release
Adverse Events and Serious Adverse Events
AEs and SAEs per standard definitions will be measured by self-report.
Measured: Eight weeks post-release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2013
- Study completionJul 2013
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Alkermes, Inc., New York City Department of Health and Mental Hygiene
- Responsible party
- Principal investigator, Joshua D. Lee, NYU Langone Health
- Investigators
- Joshua D Lee, MD MSc, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180647
- Sponsor's protocol ID
- NYU IRB Number: 09-0372
- Status last verified
- Mar 2016
- First submitted
- 10 Aug 2010
- Last updated
- 7 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.
PubMed 40342086Lee JD, McDonald R, Grossman E, McNeely J, Laska E, Rotrosen J, Gourevitch MN. Opioid treatment at release from jail using extended-release naltrexone: a pilot proof-of-concept randomized effectiveness trial. Addiction. 2015 Jun;110(6):1008-14. doi: 10.1111/add.12894. Epub 2015 Apr 5.
PubMed 25703440
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
- ClinicalTrials.gov ID
- NCT01180647
- Acronym / sponsor ID
- NYU IRB Number: 09-0372
- Conditions
- Opiate Dependence
- Keywords
- Extended-release naltrexone, Prisoners, Opioid addiction prevention, Medication Treatment Alternatives, Prevention of Relapse to Opioid Addiction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Alkermes, Inc., New York City Department of Health and Mental Hygiene
- Study start
- May 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Posted 7 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.
Detailed description
This protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. All N=40 participants receive a two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be randomized to pre-release treatment with XR-NTX. Immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly lower rates of sustained opioid relapse following release.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended-release naltrexone (XR-NTX) | Active comparator | Drug: Extended-Release NaltrexoneA single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection. |
| Motivational Enhancement Counseling Only | Placebo comparator | Behavioral: Motivational Enhancement CounselingThe randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults incarcerated in NYC jails with known release date
- DSM-IV criteria for current opioid dependence
- No current agonist (methadone, buprenorphine) treatment
- Currently opioid free by history ('detoxed') and with a negative urine for all opioids
- General good health as determined by complete medical interview and physical examination
Key exclusion criteria (6 listed)
- History of liver failure, cirrhosis, or recent liver function test levels greater than three times normal
- Pregnancy, lactation, or planning conception
- Active medical illness that might make participation hazardous
- Untreated psychiatric disorder
- History of allergic reaction to naltrexone, PLG (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent.
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 |
|---|---|---|
| Extended-Release NaltrexoneAlso: Vivitrol380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly). | Drug | Extended-release naltrexone (XR-NTX) |
| Motivational Enhancement CounselingThe randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail. | Behavioural | Motivational Enhancement Counseling Only |
Primary outcome
Post-Release Opioid Relapse
Time frame: Four weeks post-release
Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.
5 secondary outcomes
Participation in Community Drug Treatment Post-release
Time frame: Four weeks post-release
Any Opioid Use Post-release
Time frame: Four weeks post-release
Injection Drug Use Post-release
Time frame: Four weeks post-release
Accidental Drug Overdose
Time frame: Four weeks post-release
Adverse Events and Serious Adverse Events
Time frame: Eight weeks post-release
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40342086Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.
- Derived from this study: PubMed 25703440Lee JD, McDonald R, Grossman E, McNeely J, Laska E, Rotrosen J, Gourevitch MN. Opioid treatment at release from jail using extended-release naltrexone: a pilot proof-of-concept randomized effectiveness trial. Addiction. 2015 Jun;110(6):1008-14. doi: 10.1111/add.12894. Epub 2015 Apr 5.
- Individual participant dataSharing planned: No
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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.
Joshua D Lee, MD MSc principal investigator
NYU School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extended-Release Naltrexone and Motivational Enhancement Counseling in people with Opiate Dependence, run by NYU Langone Health at 2 sites 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 6 inclusion and 6 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 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 7 Apr 2016). 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?
Post-Release Opioid Relapse (time frame: Four weeks post-release). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01180647, which also lists 2 linked publications.
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 7 Apr 2016.