Opioid DependencePhase 3NCT02187198
Buprenorphine Treatment for Opioid Dependence
A Phase 3 study testing Buprenorphine in people with Opioid Dependence, run by Yale University at 1 site in United States.
Trial summary
Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this patient population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 1 Jan 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between the ages of 18 to 65, current dependence on prescription opioids as evidenced by documented prior treatment for opioid dependence, signs of opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale score of 7 or greater, self-reported history of opioid dependence, and a positive urine toxicology for opiates;
- willingness to be detoxified from opioids for buprenorphine maintenance ;
- for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy, with monthly pregnancy tests obtained during study participation.
Who cannot join
- use of heroin for more than 4 days in the past month;
- lifetime history of opioid dependence due to heroin alone;
- ever used heroin intravenously;
- requirement for current ongoing opioid treatment for adequate pain management;
- current alcohol, benzodiazepine, barbiturate use with physiologic dependence as determined during screening history and physical,
- serious unstable medical illness including bradycardia or other arrhythmias, major cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine treatment is contraindicated or which at the determination of the MD is medically dangerous;
Show all 9Show fewer
- serious psychiatric illness including psychosis, bipolar disorder with psychosis:
- or significant current suicidal or homicidal thoughts necessitating a higher level or care;
- known allergy or intolerance to buprenorphine.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System - West Haven Campus
West Haven, Connecticut, 06516
About this study
Official title: Buprenorphine Treatment for Prescription Opioid Dependence
Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this patient population. The goal of this study is to determine if there are differences in clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will be treatment retention, use of opioids, and the use of other drugs of abuse.
Read the detailed description
This is a randomized, open-label clinical trial with approximately 9 Veteran opioid dependent men and women. Veterans were randomized to one of two treatment groups: low dose range of buprenorphine (<8mg) vs. high dose range of buprenorphine/naloxone (BUP/NLX (<16mg). During induction into buprenorphine, all participants will be started at a dose of 2mg, and this dose will be increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg for the low dose group, and up to 16mg for the high dose group, within a 5 day period. Participants will be seen on a daily basis (excluding weekends) for the initial 5 day induction. At the end of the 12-week study, participants will either be referred to a buprenorphine clinic if they wish to continue this medication, or if they wish to be drug free, will undergo detoxification from buprenorphine for up to a 4-week period. Follow-up visits, scheduled at 1, 3, and 6 months after study completion.
- Conditions
- Opioid Dependence
- Being tested
- Buprenorphine
- Keywords
- Opioid Dependence, Buprenorphine
- 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.
BuprenorphineDrug
Also called Naloxone, Suboxone, Buprenex, Subutex
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine low dose | Experimental | Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks. Receives: Drug: Buprenorphine |
| Buprenorphine high dose | Experimental | Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks. Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Toxicology for Opiate Use
Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Measured: Weeks 1-12
Urine Toxicology
Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Measured: Weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startMar 2015
- Primary completion1 Feb 2022
- Study completion1 Jan 2023
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.
- More trials run by Yale UniversityThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Elizabeth Ralevski, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187198
- Sponsor's protocol ID
- IP0040
- Status last verified
- Mar 2023
- First submitted
- 8 Jul 2014
- Last updated
- 10 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine Treatment for Prescription Opioid Dependence
- ClinicalTrials.gov ID
- NCT02187198
- Acronym / sponsor ID
- IP0040
- Conditions
- Opioid Dependence
- Keywords
- Opioid Dependence, Buprenorphine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Mar 2015
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Posted 10 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this patient population. The goal of this study is to determine if there are differences in clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will be treatment retention, use of opioids, and the use of other drugs of abuse.
Detailed description
This is a randomized, open-label clinical trial with approximately 9 Veteran opioid dependent men and women. Veterans were randomized to one of two treatment groups: low dose range of buprenorphine (<8mg) vs. high dose range of buprenorphine/naloxone (BUP/NLX (<16mg). During induction into buprenorphine, all participants will be started at a dose of 2mg, and this dose will be increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg for the low dose group, and up to 16mg for the high dose group, within a 5 day period. Participants will be seen on a daily basis (excluding weekends) for the initial 5 day induction. At the end of the 12-week study, participants will either be referred to a buprenorphine clinic if they wish to continue this medication, or if they wish to be drug free, will undergo detoxification from buprenorphine for up to a 4-week period. Follow-up visits, scheduled at 1, 3, and 6 months after study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine low dose | Experimental | Drug: BuprenorphineParticipants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks. |
| Buprenorphine high dose | Experimental | Drug: BuprenorphineParticipants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females between the ages of 18 to 65, current dependence on prescription opioids as evidenced by documented prior treatment for opioid dependence, signs of opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale score of 7 or greater, self-reported history of opioid dependence, and a positive urine toxicology for opiates;
- willingness to be detoxified from opioids for buprenorphine maintenance ;
- for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy, with monthly pregnancy tests obtained during study participation.
Key exclusion criteria (9 listed)
- use of heroin for more than 4 days in the past month;
- lifetime history of opioid dependence due to heroin alone;
- ever used heroin intravenously;
- requirement for current ongoing opioid treatment for adequate pain management;
- current alcohol, benzodiazepine, barbiturate use with physiologic dependence as determined during screening history and physical,
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 |
|---|---|---|
| BuprenorphineAlso: Naloxone, Suboxone, Buprenex, Subutex | Drug | Buprenorphine high dose, Buprenorphine low dose |
Primary outcome
Urine Toxicology for Opiate Use
Time frame: Weeks 1-12
Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Urine Toxicology
Time frame: Weeks 1-12
Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- 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.
Elizabeth Ralevski, Ph.D. principal investigator
Yale University
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 in people with Opioid Dependence, run by Yale University 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 3 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 10 Mar 2023. 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 10 Mar 2023). 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?
Urine Toxicology for Opiate Use (time frame: Weeks 1-12). 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?
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 10 Mar 2023.