Opiate DependencePhase 3NCT00987961
Linking Hospitalized Injection Drug Users to Buprenorphine
A Phase 3 study testing Linkage in people with Opiate Dependence, run by Butler Hospital at 1 site in United States.
Trial summary
This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization, and then providing an appointment (a "link") for after discharge to maintenance buprenorphine in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Linkage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Current opioid injector, at least weekly in the past month
- Current opioid dependence, SCID confirmed
- Currently receiving an inpatient buprenorphine detoxification protocol.
Who cannot join
- Patients unable to be interviewed due to acute illness or cognitive impairment
- In police custody, expecting incarceration
- Persons who cannot provide two contact persons (including shelters, parole officers, etc.) to verify location
- Not able to complete assessments in English
- Enrolled in a methadone maintenance program
- Plans to leave the area within the next 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization, and then providing an appointment (a "link") for after discharge to maintenance buprenorphine in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids.
Read the detailed description
In this randomized controlled trial, medically hospitalized opioid dependent patients will be assigned to a "treatment as usual" group, where they will receive a detox regiment of Suboxone during their hospital stay, or a "linkage" group, where they receive a maintenance course of Suboxone during their hospital stay, and appointment post-discharge with an outpatient Suboxone clinic/provider and a Suboxone prescription to use between discharge and this appointment. Study interviews are completed at baseline, and 1, 3- and 6-months post-baseline. Primary outcomes are opioid use and HIV risk behavior.
- Conditions
- Opiate Dependence
- Being tested
- Linkage
- Keywords
- opioid dependence, suboxone, HIV risk behavior
- 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.
LinkageBehavioural
This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence. |
| Linkage | Experimental | Participants in this arm will receive a maintenance schedule of Suboxone during their hospital stay, and an appointment with an outpatient Suboxone provider for after their discharge. Receives: Behavioral: Linkage |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid use
Measured: baseline, 1-month, 3-months, 6-months
HIV risk behavior
Measured: baseline, 1-month, 3-months, 6-months
Secondary outcomes (2)
reduction in injection-related medical conditions
Measured: baseline, 1-month, 3-months, 6-months
reduction in emergency department and hospital utilization
Measured: baseline, 1-month, 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opiate 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
- Investigators
- Michael D Stein, MD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987961
- Sponsor's protocol ID
- 1R01DA026223
- Status last verified
- Nov 2015
- First submitted
- 30 Sep 2009
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Liebschutz JM, Crooks D, Herman D, Anderson B, Tsui J, Meshesha LZ, Dossabhoy S, Stein M. Buprenorphine treatment for hospitalized, opioid-dependent patients: a randomized clinical trial. JAMA Intern Med. 2014 Aug;174(8):1369-76. doi: 10.1001/jamainternmed.2014.2556.
PubMed 25090173Meshesha LZ, Tsui JI, Liebschutz JM, Crooks D, Anderson BJ, Herman DS, Stein MD. Days of heroin use predict poor self-reported health in hospitalized heroin users. Addict Behav. 2013 Dec;38(12):2884-7. doi: 10.1016/j.addbeh.2013.08.002. Epub 2013 Aug 14.
PubMed 24045030
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Hospitalized Injection Drug Users to Buprenorphine
- ClinicalTrials.gov ID
- NCT00987961
- Acronym / sponsor ID
- 1R01DA026223
- Conditions
- Opiate Dependence
- Keywords
- opioid dependence, suboxone, HIV risk behavior
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- Boston Medical Center
- Study start
- Sep 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization, and then providing an appointment (a "link") for after discharge to maintenance buprenorphine in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids.
Detailed description
In this randomized controlled trial, medically hospitalized opioid dependent patients will be assigned to a "treatment as usual" group, where they will receive a detox regiment of Suboxone during their hospital stay, or a "linkage" group, where they receive a maintenance course of Suboxone during their hospital stay, and appointment post-discharge with an outpatient Suboxone clinic/provider and a Suboxone prescription to use between discharge and this appointment. Study interviews are completed at baseline, and 1, 3- and 6-months post-baseline. Primary outcomes are opioid use and HIV risk behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence. |
| Linkage | Experimental | Behavioral: LinkageParticipants in this arm will receive a maintenance schedule of Suboxone during their hospital stay, and an appointment with an outpatient Suboxone provider for after their discharge. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Current opioid injector, at least weekly in the past month
- Current opioid dependence, SCID confirmed
- Currently receiving an inpatient buprenorphine detoxification protocol.
Key exclusion criteria (6 listed)
- Patients unable to be interviewed due to acute illness or cognitive impairment
- In police custody, expecting incarceration
- Persons who cannot provide two contact persons (including shelters, parole officers, etc.) to verify location
- Not able to complete assessments in English
- Enrolled in a methadone maintenance program
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 |
|---|---|---|
| LinkageThis intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge. | Behavioural | Linkage |
Primary outcome
opioid use
Time frame: baseline, 1-month, 3-months, 6-months
HIV risk behavior
Time frame: baseline, 1-month, 3-months, 6-months
2 secondary outcomes
reduction in injection-related medical conditions
Time frame: baseline, 1-month, 3-months, 6-months
reduction in emergency department and hospital utilization
Time frame: baseline, 1-month, 3-months, 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Derived from this study: PubMed 25090173Liebschutz JM, Crooks D, Herman D, Anderson B, Tsui J, Meshesha LZ, Dossabhoy S, Stein M. Buprenorphine treatment for hospitalized, opioid-dependent patients: a randomized clinical trial. JAMA Intern Med. 2014 Aug;174(8):1369-76. doi: 10.1001/jamainternmed.2014.2556.
- Derived from this study: PubMed 24045030Meshesha LZ, Tsui JI, Liebschutz JM, Crooks D, Anderson BJ, Herman DS, Stein MD. Days of heroin use predict poor self-reported health in hospitalized heroin users. Addict Behav. 2013 Dec;38(12):2884-7. doi: 10.1016/j.addbeh.2013.08.002. Epub 2013 Aug 14.
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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.
Michael D Stein, MD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Linkage in people with Opiate Dependence, run by Butler Hospital 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 4 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 11 Nov 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
opioid use (time frame: baseline, 1-month, 3-months, 6-months). The study lists 2 primary outcomes in all. 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 NCT00987961, 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 11 Nov 2015.