In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone ® ) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opioid-dependent men and women were randomized to a thirteen-day buprenorphine-naloxone taper regimen for short-term opioid detoxification. The 234 buprenorphine-naloxone patients averaged 37 years old and used mostly intravenous heroin. Direct and rapid induction onto buprenorphine-naloxone was safe and well tolerated. Most patients (83%) received 8 mg buprenorphine-2 mg naloxone on the first day and 90% successfully completed induction and reached a target dose of 16mg buprenorphine-4 mg naloxone in three days. Medication NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript compliance and treatment engagement was high. An average of 81% of available doses was ingested, and 68% of patients completed the detoxification. Most (80.3%) patients received some ancillary medications with an average of 2.3 withdrawal symptoms treated. The safety profile of buprenorphine-naloxone was excellent. Of eighteen serious adverse events reported, only one was possibly related to buprenorphine-naloxone. All providers successfully integrated buprenorphinenaloxone into their existing treatment milieus. Overall, data from the CTN field experience suggest that buprenorphine-naloxone is practical and safe for use in diverse community treatment settings, including those with minimal experience providing opioid-based pharmacotherapy and/or medical detoxification for opioid dependence.Opioid dependence and its associated disorders represent a serious public health problem in the United States and many other countries. Less than 20% of an estimated 898,000 U.S. heroin users 1 currently receive agonist treatment with methadone or LAAM. Further, sales and distribution of LAAM in the United States were discontinued in August 2003 as a result of severe cardiac-related adverse events associated with its use. Even fewer users receive antagonist treatment with naltrexone or some type of medical detoxification, followed by additional treatment such as that provided through a therapeutic community, short-term residential program, or drug-free outpatient program. Although each of these treatments can be effective, their availability and attractiveness to patients vary and are not sufficient to meet the current demand for treatment. The reasons are complex but include inadequate resources for patients to pay for current care, community resistance to new drug treatment programs (especially methadone), patient preference, and regulatory barriers that limit access to treatment.Buprenorphine hydrochloride (HCl), a derivative of the morp...

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Brain imaging and genetic studies over the past two decades suggest that substance use disorders are best considered chronic illnesses. The passing of the Affordable Care Act in the United States has set the occasion for integrating treatment of substance use disorders into mainstream healthcare; and for using the proactive, team-oriented Chronic Care Model (CCM). This paper systematically examines and compares whether and how well the CCM could be applied to the treatment of substance use disorders, using type 2 diabetes as a comparator. The chronic illness management approach is still new in the field of addiction and research is limited. However comparative findings suggest that most proactive, team treatment-oriented clinical management practices now used in diabetes management are applicable to the substance use disorders; capable of being implemented by primary care teams; and should offer comparable potential benefits in the treatment of substance use disorders. Such care should also improve the quality of care for many illnesses now negatively affected by unaddressed substance abuse.

Few studies in community settings have evaluated predictors, mediators, and moderators of treatment success for medically supervised opioid withdrawal treatment. This report presents new findings about these factors from a study of 344 opioid dependent men and women prospectively randomized to either buprenorphine-naloxone or clonidine in an open-label 13-day medically-supervised withdrawal study. Subjects were either inpatient or outpatient in community treatment settings; however not randomized by treatment setting. Medication type (buprenorphine-naloxone versus clonidine) was the single best predictor of treatment retention and treatment success, regardless of treatment setting. Compared to the outpatient setting, the inpatient setting was associated with higher abstinence rates but similar retention rates when adjusting for medication type. Early opioid withdrawal severity mediated the relationship between medication type and treatment outcome with buprenorphine-naloxone being superior to clonidine at relieving early withdrawal symptoms. Inpatient subjects on clonidine with lower withdrawal scores at baseline did better than those with higher withdrawal scores; inpatient subjects receiving buprenorphine-naloxone did better with higher withdrawal scores at baseline than those with lower withdrawal scores. No relationship was found between treatment outcome and age, gender, race, education, employment, marital status, legal problems, baseline depression, or length/severity of drug use. Tobacco use was associated with worse opioid treatment outcomes. Severe baseline anxiety symptoms doubled treatment success. Medication type (buprenorphine-naloxone) was the most important predictor of positive outcome; however the paper also considers other clinical and policy implications of other results, including that inpatient setting predicted better outcomes and moderated medication outcomes.