Opiate Dependency Relapse Clinical Trial
Official title:
Using mHealth to Aid Opioid Medication Adherence Focus Groups
The purpose of the proposed study is perform focus groups to identify and prioritize
features of the SubAID application (APP). The SubAID APP is smartphone APP being created to
support patients self-managing buprenorphine/naloxone (bup/nal) medication. Many people have
difficulty in managing bup/nal in the prescribed manner. Not taking medicines in their
prescribed manner can cause negative health outcomes.
Focus group participants will be asked to elaborate on medication-taking patterns that work
best for them, pitfalls associated with poor adherence and offer opinions upon what
features/functions the SubAID APP should perform to be most helpful to them. The focus group
is designed to remain open-ended and allow free discussion regarding each particular topic
that the moderator will bring up.
Opioid dependence (OD) is a serious medical and social quandary impacting the lives of
millions, including disparate demographic populations in the United States. Economic and
societal costs of prescription opioid abuse in the United States alone are estimated at $56
billion while the number of drug poisoning deaths attributed to opioid analgesics has more
than tripled since 1999. In 2008, opioid analgesics were involved in greater than 40% of all
drug poisoning fatalities. Opiate-agonist pharmacotherapy utilizing buprenorphine/naloxone
(bup/nal) is known to decrease illicit opiate use. However, poor medication management and
misuse during self-managed opioid substitution therapy (OST) constrains efficacy, while
aggrandizing relapse, hospitalizations and mortality. In an adherence study, OST patients
that mismanaged their medication were >10 times more likely to relapse than compliant
patients. [5] Thus, one of the most inescapable challenges confronted by health care
professionals treating OD is assuring medications are taken as prescribed to inhibit
relapse. Yet, the threats to successful medication mismanagement for substance use disorders
are unique from those of traditional chronic diseases.
While the ultimate goal of substance abuse treatment is abstinence, opioid addiction is a
chronic, relapsing medical condition. Opioid substitution therapy, incorporating methadone
or bup/nal, represents conventional treatment options for opioid dependence. Methadone
maintenance in adequate doses reduces cravings, prevents the onset of withdrawal, is not
intoxicating or sedating, and does not interfere with normal activities of daily living.
However, significant pitfalls denote methadone maintenance treatment. Methadone is a
long-acting, full opioid agonist with known abuse and diversion potential and no upper
boundary to the level of respiratory depression -- overdose can therefore be fatal. In
addition, relapse rates for methadone maintenance range between 55-90% following treatment.
Although an effective therapy, the high rates of relapse and diversion render methadone a
less than ideal solution for many patients. Recently, the bup/nal formulation, commonly sold
as Suboxone®, was designed to minimize abuse and diversion while retaining all positive
aspects of methadone treatment. Bup/nal has proven correspondingly effective in treating OD
as methadone, and more efficient in certain populations. Clinical studies have shown the
beneficial effect of bup/nal treatment in reducing subsequent opioid use. Administered
sublingually, naloxone undergoes extensive first-pass metabolism and has negligible
bioavailability; thus, when used as prescribed, the combination drug (bup/nal) produces
effects of buprenorphine alone. However, if injected, the naloxone will precipitate
withdrawal in opioid dependent patients. Thus, bup/nal is intended to reduce the risk of
illicit use by injection. An additional benefit of bup/nal OST is unsupervised use. Unlike
methadone maintenance, which generally entails a daily clinic visit, bup/nal allows the
patient increased freedom, typically requiring only one physician and pharmacy visit per
month after a stabilization period. Given its lower abuse appeal, strong effectiveness, and
clear ability to lower relapse rates, bup/nal represents a more suitable treatment option
for OD, especially in still working individuals.
In spite of moves toward more unsupervised and self-managed OST with bup/nal, monitoring and
promoting effective medication adherence is challenging for a number of reasons including
diversion, lack of motivational support to avoid opioids, and low health literacy. Affording
patients and their caregivers an interactive toolset to effectively monitor and promote
medication management during OST therefore represents a major unmet need that this project
will address. This research project will develop an interactive smartphone/tablet
application (APP), named SubAID, designed to engage and support patients receiving bup/nal
to promote and monitor adherence. In order to develop the most appropriate and effective
adherence support content for the SubAID APP, we will solicit opinions in Focus Groups from
OD subjects prescribed bup/nal to better understand the adherence complications and problems
they encounter on a daily basis.
;
Observational Model: Cohort, Time Perspective: Prospective