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.