Interim Buprenorphine: Leveraging Medication + Technology to Bridge Delays in Treatment Access
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2018 |
| Start Date: | January 2015 |
| End Date: | June 2016 |
Despite the undisputed effectiveness of agonist maintenance for treating opioid dependence,
current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an
alarming number of clinics have extensive waitlists for treatment slots. Patients can remain
on these waitlists for years, placing them at elevated risk for illicit drug use, criminal
activity, infectious disease, overdose and mortality during this period. These delays in
treatment access represent a significant barrier to the widespread delivery of effective
opioid treatment, and there is a critical need to develop creative new approaches for
mitigating these delays. Our overarching goal in this application is to develop a novel
Interim Buprenorphine Treatment (IBT) that can bridge delays in treatment access. Our
integrative treatment package includes five key components, each strategically chosen to
maximize patient access to pharmacotherapy for opioid dependence while minimizing
nonadherence, abuse and diversion: Buprenorphine, Computerized adherence monitoring, mHealth
clinical support delivered via Interactive Voice Response, Automated random call-backs for
urinalysis and adherence monitoring, and HIV+Hepatitis Education delivered via iPad. The
Primary Aim of this Stage I Behavioral and Integrative Treatment Development application is
to evaluate the feasibility and initial efficacy of IBT in a 12-week randomized trial in
which 70 opioid-dependent adults wait-listed for agonist maintenance are randomized to
receive IBT (n=35) or continue in a Waitlist Control condition (WLC; n=35). WLC participants
who have not entered treatment by Week 12 will be offered the opportunity to cross over to
IBT at that time, contributing additional within-subject data with which to evaluate the
efficacy of the IBT intervention. The proposed research is innovative in several important
ways: By facilitating the eradication of waitlists for opioid treatment, it represents a
significant departure from the status quo and stands to produce a fundamental shift in how
treatment of opioid dependence is conceptualized and delivered. The IBT components are highly
novel, both individually and as an integrative interim treatment package for opioid
dependence. This study will be the first to investigate the utility of IBT in the patients
and settings that stand to benefit most from it. The investigators also propose a
multi-pronged dissemination approach that will ensure that our work is readily transported to
clinical practice and will have a direct impact on real-world treatment of opioid dependence.
Taken together, the proposed project will produce a highly innovative technology-assisted
pharmacotherapy protocol that can be widely disseminated to increase access to life-saving
opioid treatment. The overarching and specific aims of this proposal are directly relevant to
NIDA's mission of improving the accessibility, implementation and effectiveness of drug abuse
treatment.
current capacity is inadequate to meet need in the U.S. and internationally. Indeed, an
alarming number of clinics have extensive waitlists for treatment slots. Patients can remain
on these waitlists for years, placing them at elevated risk for illicit drug use, criminal
activity, infectious disease, overdose and mortality during this period. These delays in
treatment access represent a significant barrier to the widespread delivery of effective
opioid treatment, and there is a critical need to develop creative new approaches for
mitigating these delays. Our overarching goal in this application is to develop a novel
Interim Buprenorphine Treatment (IBT) that can bridge delays in treatment access. Our
integrative treatment package includes five key components, each strategically chosen to
maximize patient access to pharmacotherapy for opioid dependence while minimizing
nonadherence, abuse and diversion: Buprenorphine, Computerized adherence monitoring, mHealth
clinical support delivered via Interactive Voice Response, Automated random call-backs for
urinalysis and adherence monitoring, and HIV+Hepatitis Education delivered via iPad. The
Primary Aim of this Stage I Behavioral and Integrative Treatment Development application is
to evaluate the feasibility and initial efficacy of IBT in a 12-week randomized trial in
which 70 opioid-dependent adults wait-listed for agonist maintenance are randomized to
receive IBT (n=35) or continue in a Waitlist Control condition (WLC; n=35). WLC participants
who have not entered treatment by Week 12 will be offered the opportunity to cross over to
IBT at that time, contributing additional within-subject data with which to evaluate the
efficacy of the IBT intervention. The proposed research is innovative in several important
ways: By facilitating the eradication of waitlists for opioid treatment, it represents a
significant departure from the status quo and stands to produce a fundamental shift in how
treatment of opioid dependence is conceptualized and delivered. The IBT components are highly
novel, both individually and as an integrative interim treatment package for opioid
dependence. This study will be the first to investigate the utility of IBT in the patients
and settings that stand to benefit most from it. The investigators also propose a
multi-pronged dissemination approach that will ensure that our work is readily transported to
clinical practice and will have a direct impact on real-world treatment of opioid dependence.
Taken together, the proposed project will produce a highly innovative technology-assisted
pharmacotherapy protocol that can be widely disseminated to increase access to life-saving
opioid treatment. The overarching and specific aims of this proposal are directly relevant to
NIDA's mission of improving the accessibility, implementation and effectiveness of drug abuse
treatment.
Agonist maintenance is the most efficacious treatment for opioid dependence. Unfortunately,
demand for treatment far exceeds available capacity. An alarming number of clinics have
extensive waitlists for treatment slots (Gryczynski et al., 2009; Peles et al., 2012;
Peterson et al., 2010). Patients can remain on these waitlists for years, placing them at
elevated risk for illicit drug use, criminal activity, infectious disease, overdose and
mortality during this period (Peles et al., 2013; Warner-Smith et al., 2001; Wenger &
Rosenbaum, 1994). These delays in treatment access represent a significant barrier to the
widespread delivery of effective opioid treatment, particularly in rural areas where there
are fewer providers and substantial unmet treatment need. One important effort to increase
access has been to extend interim methadone treatment (IMT; i.e., daily methadone + emergency
counseling only) to individuals awaiting enrollment into a methadone program. IMT
significantly reduces illicit opioid use and criminality and increases likelihood of
treatment entry (Schwartz et al., 2006, 2007, 2009a,b, 2011). However, methadone treatment in
the U.S. is limited to licensed specialty clinics, it requires frequent clinic visits, and
the medication itself has risks of diversion, abuse and overdose. Hence, methadone's
regulatory and pharmacological features substantially constrain the ability of IMT to expand
access to opioid treatment.
Our overarching goal in this application is to develop a novel Interim Buprenorphine
Treatment (IBT) that can bridge delays in treatment access. Our integrative treatment package
includes five key components, each strategically chosen to maximize patient access to
pharmacotherapy for opioid dependence while minimizing nonadherence, abuse and diversion: (1)
Buprenorphine (BUP): Due to its pharmacological profile, BUP has less risk of abuse and
overdose and is available without the rigid dosing regulations required for methadone. Thus,
we will use BUP in this interim-treatment model. (2) Computerized adherence monitoring (CAM):
We will use CAM to promote medication adherence and reduce diversion risk. BUP doses will be
dispensed via a state-of-the-art portable device that makes each day's dose available only at
a predetermined time, after which all medication is inaccessible. (3) Mobile health clinical
support: mHealth platforms use information and communication technology to deliver patient
monitoring, education and support beyond the confines of the medical office. Interactive
Voice Response (IVR) systems are especially promising in that they provide customized support
via phone with low cost, consistent delivery, 24-hour availability, privacy and convenience.
We will develop an IVR system to deliver clinical support with branching logic in a seamless
fashion as well as immediate connection with staff or crisis service if needed. (4)
Urinalysis and adherence monitoring: We will develop an automated call-back procedure to
contact participants via IVR at randomly-determined intervals and notify them to return to
the clinic to provide a urine specimen and present the CAM device for inspection. This
component will provide a rigorous but efficient method for supporting abstinence and
adherence over an extended period of lower-frequency visits. (5) HIV+Hepatitis Education: We
have developed an intervention that produces significant improvements in HIV and hepatitis
knowledge. However its resource-intensive in-person format may limit its utility in IBT. We
will adapt our intervention for delivery via iPad, a state-of-the-art platform with
portability, sophisticated functionality and widespread appeal.
The primary aim of this Stage I Behavioral and Integrative Treatment Development application
is to develop a novel, manual-based IBT platform to increase access to opioid treatment.
During Months 1-6 we will refine treatment components using feedback from stakeholders.
During the remaining study period, we will evaluate the feasibility, acceptability and
initial efficacy of IBT in a 12-week proof-of-concept trial in which 70 opioid-dependent
adults wait-listed for agonist maintenance are randomized to receive IBT (n=35) or continue
in a Waitlist Control condition (WLC; n=35). IBT participants will visit the clinic every 2
weeks while receiving the IBT package described above. WLC participants will remain on the
waitlist for their treatment of choice but complete the same scheduled follow-up assessments
as IBT participants. WLC participants who have not entered treatment by Week 12 will be
offered the opportunity to cross over to IBT at that time, contributing additional
within-subject data with which to evaluate the efficacy of the IBT intervention.
By facilitating the eradication of waitlists, the proposed research represents a significant
departure from the status quo and stands to produce a fundamental shift in how treatment of
opioid dependence is conceptualized and delivered. The IBT components are highly novel, both
individually and as an integrative treatment package for opioid dependence. This study will
also be the first to investigate the utility of IBT in the patients and settings that stand
to benefit most from it and includes a multi-pronged dissemination plan to ensure that our
findings are readily transported into real-world clinical practice. Taken together, the
proposed project will produce a highly innovative technology-assisted pharmacotherapy
protocol that can be widely disseminated to increase access to life-saving opioid treatment.
These aims are directly relevant to NIDA's mission of improving the accessibility,
implementation and effectiveness of drug abuse treatment.
demand for treatment far exceeds available capacity. An alarming number of clinics have
extensive waitlists for treatment slots (Gryczynski et al., 2009; Peles et al., 2012;
Peterson et al., 2010). Patients can remain on these waitlists for years, placing them at
elevated risk for illicit drug use, criminal activity, infectious disease, overdose and
mortality during this period (Peles et al., 2013; Warner-Smith et al., 2001; Wenger &
Rosenbaum, 1994). These delays in treatment access represent a significant barrier to the
widespread delivery of effective opioid treatment, particularly in rural areas where there
are fewer providers and substantial unmet treatment need. One important effort to increase
access has been to extend interim methadone treatment (IMT; i.e., daily methadone + emergency
counseling only) to individuals awaiting enrollment into a methadone program. IMT
significantly reduces illicit opioid use and criminality and increases likelihood of
treatment entry (Schwartz et al., 2006, 2007, 2009a,b, 2011). However, methadone treatment in
the U.S. is limited to licensed specialty clinics, it requires frequent clinic visits, and
the medication itself has risks of diversion, abuse and overdose. Hence, methadone's
regulatory and pharmacological features substantially constrain the ability of IMT to expand
access to opioid treatment.
Our overarching goal in this application is to develop a novel Interim Buprenorphine
Treatment (IBT) that can bridge delays in treatment access. Our integrative treatment package
includes five key components, each strategically chosen to maximize patient access to
pharmacotherapy for opioid dependence while minimizing nonadherence, abuse and diversion: (1)
Buprenorphine (BUP): Due to its pharmacological profile, BUP has less risk of abuse and
overdose and is available without the rigid dosing regulations required for methadone. Thus,
we will use BUP in this interim-treatment model. (2) Computerized adherence monitoring (CAM):
We will use CAM to promote medication adherence and reduce diversion risk. BUP doses will be
dispensed via a state-of-the-art portable device that makes each day's dose available only at
a predetermined time, after which all medication is inaccessible. (3) Mobile health clinical
support: mHealth platforms use information and communication technology to deliver patient
monitoring, education and support beyond the confines of the medical office. Interactive
Voice Response (IVR) systems are especially promising in that they provide customized support
via phone with low cost, consistent delivery, 24-hour availability, privacy and convenience.
We will develop an IVR system to deliver clinical support with branching logic in a seamless
fashion as well as immediate connection with staff or crisis service if needed. (4)
Urinalysis and adherence monitoring: We will develop an automated call-back procedure to
contact participants via IVR at randomly-determined intervals and notify them to return to
the clinic to provide a urine specimen and present the CAM device for inspection. This
component will provide a rigorous but efficient method for supporting abstinence and
adherence over an extended period of lower-frequency visits. (5) HIV+Hepatitis Education: We
have developed an intervention that produces significant improvements in HIV and hepatitis
knowledge. However its resource-intensive in-person format may limit its utility in IBT. We
will adapt our intervention for delivery via iPad, a state-of-the-art platform with
portability, sophisticated functionality and widespread appeal.
The primary aim of this Stage I Behavioral and Integrative Treatment Development application
is to develop a novel, manual-based IBT platform to increase access to opioid treatment.
During Months 1-6 we will refine treatment components using feedback from stakeholders.
During the remaining study period, we will evaluate the feasibility, acceptability and
initial efficacy of IBT in a 12-week proof-of-concept trial in which 70 opioid-dependent
adults wait-listed for agonist maintenance are randomized to receive IBT (n=35) or continue
in a Waitlist Control condition (WLC; n=35). IBT participants will visit the clinic every 2
weeks while receiving the IBT package described above. WLC participants will remain on the
waitlist for their treatment of choice but complete the same scheduled follow-up assessments
as IBT participants. WLC participants who have not entered treatment by Week 12 will be
offered the opportunity to cross over to IBT at that time, contributing additional
within-subject data with which to evaluate the efficacy of the IBT intervention.
By facilitating the eradication of waitlists, the proposed research represents a significant
departure from the status quo and stands to produce a fundamental shift in how treatment of
opioid dependence is conceptualized and delivered. The IBT components are highly novel, both
individually and as an integrative treatment package for opioid dependence. This study will
also be the first to investigate the utility of IBT in the patients and settings that stand
to benefit most from it and includes a multi-pronged dissemination plan to ensure that our
findings are readily transported into real-world clinical practice. Taken together, the
proposed project will produce a highly innovative technology-assisted pharmacotherapy
protocol that can be widely disseminated to increase access to life-saving opioid treatment.
These aims are directly relevant to NIDA's mission of improving the accessibility,
implementation and effectiveness of drug abuse treatment.
Inclusion Criteria:
- For inclusion in the trial, participants must be >18 years old, in good health, meet
DSM-IV criteria for opioid dependence, provide an opioid-positive urine and be
currently waitlisted.
- To minimize disruption due to treatment becoming available during the study, we will
limit enrollment to those who joined a waitlist in the prior 12 months.
Exclusion Criteria:
- Those with a significant psychiatric or medical illness that may interfere with
consent or participation will be excluded, as will those who are pregnant or nursing.
- Females will be tested for pregnancy and, should a participant become pregnant during
the trial, her participation will be terminated and she will be assisted with
accessing treatment at the high-risk pregnancy clinic.
- Those dependent on sedative-hypnotics will be excluded, due to the medical risks and
notably low success rates with sedative-dependent opioid abusers (Stitzer & Chutuape,
1999).
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