Heroin DependencePhase 3NCT03711318
Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
A Phase 3 study testing Buprenorphine/naloxone in people with Heroin Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heroin Dependence
- What is being tested?
- Buprenorphine/naloxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 31 Dec 2021
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals between the ages of 18-60
- Meets DSM-5 criteria of current opioid use disorder with six consecutive months of reported heroin use, supported by a positive urine for opiates indicating regular use of heroin
- Seeking treatment for opioid use disorder with Vivitrol
- Capable of giving informed consent and complying with study procedures
- In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG
- BMI between 18-40
Who cannot join
- Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent
- Maintenance on, or regular use of buprenorphine or other prescription opioids
- Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT > 3 times normal, AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection), unstable diabetes, cardiovascular disease.
- Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, or suicide risk or 1 or more suicide attempts within the past year.
- Physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.
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- History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
- Chronic neurocognitive disorder
- History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
- Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications
- Fentanyl only use, supported by a urine toxicology that is positive for fentanyl only and negative for all other opioids.
- Court mandated to treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol.
- Conditions
- Heroin Dependence
- Being tested
- Buprenorphine/naloxone
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine/naloxoneDrug
3 week treatment with buprenorphine/naloxone
| Study group | Role | What they receive |
|---|---|---|
| Short-term treatment with buprenorphine | Experimental | Short-term treatment with buprenorphine Receives: Drug: Buprenorphine/naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol
Number of patients who received the first Vivitrol injection among those who initiated the induction
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: continuing study was no longer feasible
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 Heroin 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Alkermes, Inc.
- Responsible party
- Principal investigator, Adam Bisaga, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711318
- Sponsor's protocol ID
- 7699
- Status last verified
- Nov 2022
- First submitted
- 16 Oct 2018
- Last updated
- 22 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
- ClinicalTrials.gov ID
- NCT03711318
- Acronym / sponsor ID
- 7699
- Conditions
- Heroin Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: continuing study was no longer feasible
- Enrolment
- 8 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Alkermes, Inc.
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Posted 22 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short-term treatment with buprenorphine | Experimental | Drug: Buprenorphine/naloxoneShort-term treatment with buprenorphine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Individuals between the ages of 18-60
- Meets DSM-5 criteria of current opioid use disorder with six consecutive months of reported heroin use, supported by a positive urine for opiates indicating regular use of heroin
- Seeking treatment for opioid use disorder with Vivitrol
- Capable of giving informed consent and complying with study procedures
- In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG
Key exclusion criteria (12 listed)
- Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent
- Maintenance on, or regular use of buprenorphine or other prescription opioids
- Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT > 3 times normal, AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection), unstable diabetes, cardiovascular disease.
- Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, or suicide risk or 1 or more suicide attempts within the past year.
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 |
|---|---|---|
| Buprenorphine/naloxone3 week treatment with buprenorphine/naloxone | Drug | Short-term treatment with buprenorphine |
Primary outcome
Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol
Time frame: 12 weeks
Number of patients who received the first Vivitrol injection among those who initiated the induction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Buprenorphine/naloxone in people with Heroin Dependence, run by New York State Psychiatric Institute 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 22 Dec 2022. 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?
Yes. Results are posted in the registry (first posted 22 Dec 2022). 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?
Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol (time frame: 12 weeks). 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 22 Dec 2022.