Opioid-Related DisordersPhase 2/3NCT00684554
Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial
A Phase 2/3 study testing Buprenorphine in people with Opioid-Related Disorders and Heroin Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-Related Disorders, Heroin Dependence
- What is being tested?
- Buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Apr 2010
- Phase
- Phase 2/3
- 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
- DSM-IV criteria for current opioid dependence with physical dependence and are seeking treatment
- Recent opioid use
- Individuals must describe opioids as their primary drug of abuse.
- 18-65 years of age
- Able to give informed consent and comply with study procedures
- Financially able to receive treatment at AIM and obtain medication (e.g., Medicaid)
Who cannot join
- DSM-IV opioid dependence without physical dependence
- Any current Axis I psychiatric disorder(s) as defined by DSM-IV-TR that in the investigator's judgment are unstable or would be disrupted by study participation (e.g., psychosis, active suicidal or homicidal ideation).
- Individuals who are significant risk for suicide based on their current mental state or history.
- DSM-IV alcohol or benzodiazepine dependence with physiologic dependence.
- Pregnancy, lactation. Women must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study.
- Unstable physical disorder that might make participation hazardous.
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- Individuals with a known allergy, sensitivity or adverse reaction to buprenorphine.
- Past life-threatening idiosyncratic severe opioid withdrawal reaction (e.g., psychosis, seizure)
- Current buprenorphine maintenance
- Current long-acting opioid use (e.g., methadone)
- Inability to read or understand the self-report assessment forms unaided
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University/New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial of At-Home Versus In-Office Buprenorphine Induction
The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic.
Read the detailed description
Buprenorphine maintenance is an effective treatment for opioid dependence, yet diffusion has been limited. Physician concern about induction is a reported barrier, primarily as buprenorphine may precipitate withdrawal due to its partial opioid agonist activity and high receptor binding affinity. To minimize risk, guidelines recommend in-office assessment and monitoring during induction. As this may not be feasible (e.g., time limitations), many patients are instructed to self-induct at home. While this may facilitate treatment entry, data on at-home induction are limited. The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic. Currently, patients receive buprenorphine maintenance at AIM as part of standard clinical practice and through an observational study (IRB 5258). Most patients are insured through Medicaid, which covers visit, medication (obtained through prescription from a local pharmacy), lab, and outside psychosocial treatment cost. In this demonstration project, 20 opioid dependent patients will be randomly assigned to at-home or in-office induction, and then monitored for 12 weeks. Ancillary psychosocial treatment will be encouraged but not required. After randomization, AIM clinic and NYSPI research visits will be scheduled weekly for 4 weeks, and then at weeks 8 and 12. The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Secondary outcomes will include: 1) Time to stabilization after buprenorphine initiation assessed by: a) Time until the patient is without withdrawal for two consecutive days, and b) Time until the patient is opioid free for two consecutive weeks; and 3) Retention-in-treatment at 4 and 12 weeks. Other secondary outcomes include patient satisfaction and change in addiction severity. These data will provide important information in buprenorphine initiation in primary care and enable determination of treatment effects size prior to future clinical trials.
- Conditions
- Opioid-Related Disorders, Heroin Dependence
- Being tested
- Buprenorphine
- Keywords
- Heroin Dependence, Opioid Dependence, Primary Care, Buprenorphine
- Medical subject headings
- Opioid-Related Disorders, Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Also called Bup
Dose is determined according to the participants' individual need.
| Study group | Role | What they receive |
|---|---|---|
| Unobserved-at home | Active comparator | Buprenorphine Unobserved at home induction Receives: Drug: Buprenorphine |
| Observed | Active comparator | Buprenorphine Observed in office induction Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.
The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.
Measured: one week after initial primary care visit
Secondary outcomes (1)
Prolonged Withdrawal
participants experiencing prolonged withdrawal beyond two days after buprenorphine induction
Measured: a) 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2008
- Study completionApr 2010
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-Related DisordersStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Frances R Levin, New York State Psychiatric Institute
- Investigators
- Erik W Gunderson, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684554
- Sponsor's protocol ID
- #5600
- Other IDs
- K23DA020000
- Status last verified
- Apr 2019
- First submitted
- 22 May 2008
- Last updated
- 24 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine Maintenance Treatment of Opioid Dependence in Primary Care: A Randomized Clinical Trial of At-Home Versus In-Office Buprenorphine Induction
- ClinicalTrials.gov ID
- NCT00684554
- Acronym / sponsor ID
- #5600
- Conditions
- Opioid-Related Disorders, Heroin Dependence
- Keywords
- Heroin Dependence, Opioid Dependence, Primary Care, Buprenorphine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 11 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic.
Detailed description
Buprenorphine maintenance is an effective treatment for opioid dependence, yet diffusion has been limited. Physician concern about induction is a reported barrier, primarily as buprenorphine may precipitate withdrawal due to its partial opioid agonist activity and high receptor binding affinity. To minimize risk, guidelines recommend in-office assessment and monitoring during induction. As this may not be feasible (e.g., time limitations), many patients are instructed to self-induct at home. While this may facilitate treatment entry, data on at-home induction are limited. The study will assess the effectiveness of at-home vs. in-office induction for patients entering buprenorphine maintenance at Associates in Internal Medicine (AIM) primary care clinic. Currently, patients receive buprenorphine maintenance at AIM as part of standard clinical practice and through an observational study (IRB 5258). Most patients are insured through Medicaid, which covers visit, medication (obtained through prescription from a local pharmacy), lab, and outside psychosocial treatment cost. In this demonstration project, 20 opioid dependent patients will be randomly assigned to at-home or in-office induction, and then monitored for 12 weeks. Ancillary psychosocial treatment will be encouraged but not required. After randomization, AIM clinic and NYSPI research visits will be scheduled weekly for 4 weeks, and then at weeks 8 and 12. The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Secondary outcomes will include: 1) Time to stabilization after buprenorphine initiation assessed by: a) Time until the patient is without withdrawal for two consecutive days, and b) Time until the patient is opioid free for two consecutive weeks; and 3) Retention-in-treatment at 4 and 12 weeks. Other secondary outcomes include patient satisfaction and change in addiction severity. These data will provide important information in buprenorphine initiation in primary care and enable determination of treatment effects size prior to future clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unobserved-at home | Active comparator | Drug: BuprenorphineBuprenorphine Unobserved at home induction |
| Observed | Active comparator | Drug: BuprenorphineBuprenorphine Observed in office induction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DSM-IV criteria for current opioid dependence with physical dependence and are seeking treatment
- Recent opioid use
- Individuals must describe opioids as their primary drug of abuse.
- 18-65 years of age
- Able to give informed consent and comply with study procedures
Key exclusion criteria (11 listed)
- DSM-IV opioid dependence without physical dependence
- Any current Axis I psychiatric disorder(s) as defined by DSM-IV-TR that in the investigator's judgment are unstable or would be disrupted by study participation (e.g., psychosis, active suicidal or homicidal ideation).
- Individuals who are significant risk for suicide based on their current mental state or history.
- DSM-IV alcohol or benzodiazepine dependence with physiologic dependence.
- Pregnancy, lactation. Women must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study.
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: BupDose is determined according to the participants' individual need. | Drug | Observed, Unobserved-at home |
Primary outcome
The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit.
Time frame: one week after initial primary care visit
The primary outcome will include a comparison of the proportion of patients successfully inducted one week after the initial primary care visit. Defined as in treatment, on Buprenorphine and withdrawal free.
1 secondary outcome
Prolonged Withdrawal
Time frame: a) 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- 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.
Erik W Gunderson, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Buprenorphine in people with Opioid-Related Disorders and 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 11 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 24 Apr 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 Jan 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?
The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. (time frame: one week after initial primary care visit). 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 24 Apr 2019.