A Phase 2/3 interventional study of Buprenorphine in Opioid-Related Disorders and Heroin Dependence, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-24.
Sponsored by New York State Psychiatric Institute · Phase 2/3, Interventional, and Treatment
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.
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.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 20 is below the median of 87 across 57 interventional studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Compared within Heroin Dependence, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Opioid-Related Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Buprenorphine Unobserved at home induction
Drug: Buprenorphine
Buprenorphine Observed in office induction
Drug: Buprenorphine
Dose is determined according to the participants' individual need.
Also known as: Bup
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.
Time frame: one week after initial primary care visit
Prolonged Withdrawal
participants experiencing prolonged withdrawal beyond two days after buprenorphine induction
Time frame: a) 2 days
Twenty patients were recruited between December 2007-June 2008 through referrals from clinical and research groups at Columbia University Medical Center and locally posted flyers.
| Milestone | Unobserved-at Home | Observed |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| participants | Unobserved-at Home | Observed |
|---|---|---|
| The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. | 6 | 6 |
participants experiencing prolonged withdrawal beyond two days after buprenorphine induction
| participants | Unobserved-at Home | Observed |
|---|---|---|
| Prolonged Withdrawal | 3 | 3 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unobserved-at Home | — | 0/10 (0%) | 3/10 (30%) |
| Observed | — | 0/10 (0%) | 3/10 (30%) |
| Event | Unobserved-at Home | Observed |
|---|---|---|
| Prolonged withdrawalGastrointestinal disorders | 3/10 | 3/10 |
Adult Opioid Dependent treatment seekers
| Age, Categorical(Participants) | Unobserved-at Home | Observed | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Unobserved-at Home | Observed | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 9 | 9 | 18 |
| Region of Enrollment(participants) | Unobserved-at Home | Observed | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
The record gives a start of Dec 2007, a primary completion of Aug 2008 and a completion of Apr 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2016, 7 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Buprenorphine
New York State Psychiatric Institute →