Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/17/2018 |
| Start Date: | March 1, 2018 |
| End Date: | July 2021 |
| Contact: | Stacey C Sigmon, PhD |
| Email: | ssigmon@uvm.edu |
| Phone: | 802-656-9987 |
Despite the demonstrated effectiveness of agonist treatment for opioid dependence and
alarming recent increases in overdose deaths, waiting lists for treatment persist. In a
Behavioral & Integrative Treatment Development pilot study, the investigators demonstrated
the initial efficacy a novel Interim Buprenorphine Treatment (IBT) to mitigate the risks
(e.g., illicit opioid use, IV drug use) associated with treatment delays. However, consistent
with that R34 mechanism, our initial pilot study involved a limited sample size and was
conducted at a single academic, well-controlled research clinic with an extensive history of
research.
It is important to replicate these very positive pilot results and begin to evaluate whether
they generalize to less-controlled rural environments that are being so adversely impacted by
the current opioid abuse epidemic. In this Stage II randomized parallel two-group trial, the
investigators will evaluate the efficacy of IBT using a larger sample of 200 waitlisted
opioid-dependent adults. UVM will serve as the coordinating center and primary recruitment
site where the research team will enroll 100 participants (50 IBT, 50 WLC). The investigators
will partner with health centers in rural Vermont counties to enroll the remaining 100
participants (50 IBT, 50 WLC). The proposed research builds directly on the promising Stage I
results and has the potential to substantially reduce the vast individual and societal costs
associated with opioid treatment delays.
alarming recent increases in overdose deaths, waiting lists for treatment persist. In a
Behavioral & Integrative Treatment Development pilot study, the investigators demonstrated
the initial efficacy a novel Interim Buprenorphine Treatment (IBT) to mitigate the risks
(e.g., illicit opioid use, IV drug use) associated with treatment delays. However, consistent
with that R34 mechanism, our initial pilot study involved a limited sample size and was
conducted at a single academic, well-controlled research clinic with an extensive history of
research.
It is important to replicate these very positive pilot results and begin to evaluate whether
they generalize to less-controlled rural environments that are being so adversely impacted by
the current opioid abuse epidemic. In this Stage II randomized parallel two-group trial, the
investigators will evaluate the efficacy of IBT using a larger sample of 200 waitlisted
opioid-dependent adults. UVM will serve as the coordinating center and primary recruitment
site where the research team will enroll 100 participants (50 IBT, 50 WLC). The investigators
will partner with health centers in rural Vermont counties to enroll the remaining 100
participants (50 IBT, 50 WLC). The proposed research builds directly on the promising Stage I
results and has the potential to substantially reduce the vast individual and societal costs
associated with opioid treatment delays.
Despite the demonstrated effectiveness of agonist treatment for opioid dependence and
alarming recent increases in overdose deaths, waiting lists for treatment persist.
Opioid-dependent individuals can remain on waitlists for months, during which they are at
substantial risk for illicit drug use, criminal activity, infectious disease, overdose and
premature death. One effort to reduce these risks has been to extend interim methadone
treatment (IMT; i.e., daily methadone without counseling) to individuals awaiting entry into
a methadone program. IMT significantly reduces illicit opioid use and criminality during
treatment delays. However, it is limited to licensed specialty clinics, requires daily
visits, prohibits take-home doses and cannot exceed a 120-day duration. These regulatory
restrictions have constrained the widespread use of IMT.
With a Behavioral & Integrative Treatment Development R34, the investigators have developed a
novel Interim Buprenorphine Treatment (IBT) to mitigate the risks associated with treatment
delays while surmounting the limitations noted above for methadone. It includes key
components to permit delivery of potentially life-saving pharmacotherapy while minimizing
nonadherence: (a) Buprenorphine (BUP) offers a regulatory and safety profile that is uniquely
compatible with interim dosing. Participants receive BUP maintenance with bi-monthly clinic
visits and the remaining doses dispensed at home via a secure computerized portable device
(Med-O-Wheel, Addoz, Finland). Participants also receive (b) nightly calls from an automated
Interactive Voice Response (IVR) phone system to assess any drug use, withdrawal and craving,
(c) IVR-generated random call-backs for urinalysis and pill counts, and (d) HIV+Hepatitis
education delivered via iPad.
Our Stage I pilot data strongly support the initial efficacy of this intervention. Among 50
waitlisted opioid-dependent adults randomized to IBT (n=25) or Waitlist Control (WLC; n=25)
conditions for 12 weeks, 85%, 84% and 68% of IBT participants are abstinent at 4, 8 and
12-week assessments vs. 0%, 0% and 0% of WLC participants (p<.001). IBT participants are also
reporting greater reductions in illicit opioid use and IV drug use frequency and completing
96% of daily IVR calls and random call-backs. These outcomes represent a substantial first
step towards the development of an intervention that can reduce individual and societal risks
during delays to conventional treatment.
However, consistent with the R34 mechanism, our initial pilot study involved a limited sample
size and was conducted at a single academic, well-controlled research clinic with an
extensive history of research. It is important to replicate these very positive pilot results
and begin to evaluate whether they generalize to less-controlled rural environments that are
being so adversely impacted by the current opioid abuse epidemic. Important to underscore is
that our IBT components (i.e., Med-O-Wheel, IVR, HIV+Hepatitis application) are highly
transportable, which increases the potential of extending them to sites outside of the
university setting while retaining efficacy.
Primary Aim: In this Stage II randomized parallel two-group trial, the research team will
evaluate the efficacy of IBT using a larger sample of 200 waitlisted opioid-dependent adults.
UVM will serve as the coordinating center and primary recruitment site where investigators
will enroll 100 participants (50 IBT, 50 WLC). The research team will partner with health
centers in rural Vermont counties to enroll the remaining 100 participants (50 IBT, 50 WLC).
Participants randomized to IBT will receive the intervention described above; WLC
participants will remain on the waitlist for their treatment of choice but complete the same
4-, 8- and 12-week assessments. It is hypothesized that IBT participants will achieve
significantly greater illicit opioid abstinence relative to WLC participants.
The proposed research builds directly on the promising Stage I results and has the potential
to substantially reduce the vast individual and societal costs associated with opioid
treatment delays. By facilitating the eradication of waitlists, this project represents a
significant departure from the status quo and stands to produce a fundamental shift in how
treatment for opioid dependence is conceptualized and delivered.
alarming recent increases in overdose deaths, waiting lists for treatment persist.
Opioid-dependent individuals can remain on waitlists for months, during which they are at
substantial risk for illicit drug use, criminal activity, infectious disease, overdose and
premature death. One effort to reduce these risks has been to extend interim methadone
treatment (IMT; i.e., daily methadone without counseling) to individuals awaiting entry into
a methadone program. IMT significantly reduces illicit opioid use and criminality during
treatment delays. However, it is limited to licensed specialty clinics, requires daily
visits, prohibits take-home doses and cannot exceed a 120-day duration. These regulatory
restrictions have constrained the widespread use of IMT.
With a Behavioral & Integrative Treatment Development R34, the investigators have developed a
novel Interim Buprenorphine Treatment (IBT) to mitigate the risks associated with treatment
delays while surmounting the limitations noted above for methadone. It includes key
components to permit delivery of potentially life-saving pharmacotherapy while minimizing
nonadherence: (a) Buprenorphine (BUP) offers a regulatory and safety profile that is uniquely
compatible with interim dosing. Participants receive BUP maintenance with bi-monthly clinic
visits and the remaining doses dispensed at home via a secure computerized portable device
(Med-O-Wheel, Addoz, Finland). Participants also receive (b) nightly calls from an automated
Interactive Voice Response (IVR) phone system to assess any drug use, withdrawal and craving,
(c) IVR-generated random call-backs for urinalysis and pill counts, and (d) HIV+Hepatitis
education delivered via iPad.
Our Stage I pilot data strongly support the initial efficacy of this intervention. Among 50
waitlisted opioid-dependent adults randomized to IBT (n=25) or Waitlist Control (WLC; n=25)
conditions for 12 weeks, 85%, 84% and 68% of IBT participants are abstinent at 4, 8 and
12-week assessments vs. 0%, 0% and 0% of WLC participants (p<.001). IBT participants are also
reporting greater reductions in illicit opioid use and IV drug use frequency and completing
96% of daily IVR calls and random call-backs. These outcomes represent a substantial first
step towards the development of an intervention that can reduce individual and societal risks
during delays to conventional treatment.
However, consistent with the R34 mechanism, our initial pilot study involved a limited sample
size and was conducted at a single academic, well-controlled research clinic with an
extensive history of research. It is important to replicate these very positive pilot results
and begin to evaluate whether they generalize to less-controlled rural environments that are
being so adversely impacted by the current opioid abuse epidemic. Important to underscore is
that our IBT components (i.e., Med-O-Wheel, IVR, HIV+Hepatitis application) are highly
transportable, which increases the potential of extending them to sites outside of the
university setting while retaining efficacy.
Primary Aim: In this Stage II randomized parallel two-group trial, the research team will
evaluate the efficacy of IBT using a larger sample of 200 waitlisted opioid-dependent adults.
UVM will serve as the coordinating center and primary recruitment site where investigators
will enroll 100 participants (50 IBT, 50 WLC). The research team will partner with health
centers in rural Vermont counties to enroll the remaining 100 participants (50 IBT, 50 WLC).
Participants randomized to IBT will receive the intervention described above; WLC
participants will remain on the waitlist for their treatment of choice but complete the same
4-, 8- and 12-week assessments. It is hypothesized that IBT participants will achieve
significantly greater illicit opioid abstinence relative to WLC participants.
The proposed research builds directly on the promising Stage I results and has the potential
to substantially reduce the vast individual and societal costs associated with opioid
treatment delays. By facilitating the eradication of waitlists, this project represents a
significant departure from the status quo and stands to produce a fundamental shift in how
treatment for opioid dependence is conceptualized and delivered.
Inclusion Criteria:
- For inclusion, participants must be >=18 years old, in good health, meet DSM-V
criteria for opioid use disorder, provide an opioid-positive urine and be currently
waitlisted with a community opioid treatment clinic or provider.
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.
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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