Bringing Buprenorphine‐Naloxone Detoxification to Community Treatment Providers: The NIDA Clinical Trials Network Field Experience

Abstract

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...

Innovation adoption in substance abuse treatment: Exposure, trialability, and the Clinical Trials Network

“…Published results indicate that buprenorphine performed favorably compared to clonidine in terms of both treatment retention and drug-free urine tests (Ling et al, 2005). Equally important, buprenorphine protocols were successfully implemented in both inpatient and outpatient settings, including treatment programs having little or no prior experience with medication-assisted detoxification or maintenance for opioid dependence treatment (Amass et al, 2004). To facilitate the dissemination of buprenorphine to the broader treatment field, NIDA and SAMHSA's Addiction Technology Transfer Centers (ATTCs) have recently developed and made available technology transfer materials, including training materials for interested providers.…”

The adoption of medications in substance abuse treatment: Associations with organizational characteristics and technology clusters

“…Numerous clinical trials have evaluated the effectiveness of buprenorphine in comparison to placebo , clonidine (Ling et al, 2005;Gowling et al, 2004;Lintzeris et al, 2002), and methadone (Johnson et al, 1992;Johnson et al, 2000;Pani et al, 2000;Schottenfeld et al, 1997;Strain et al, 1994). Although buprenorphine may not be more effective than methadone, it has three key advantages: it does not require daily dosing (Amass et al, 2001), its chemical composition reduces the likelihood of diversion (Amass et al, 2000), and federal regulations encouraging its prescription by primary care physicians may facilitate its integration into community-based treatment programs (Amass et al, 2004). However, there are still are certain regulatory requirements that must be met in order for physicians to prescribe this medication (Koch et al, 2006).…”

Organizational Readiness for Change and opinions toward treatment innovations

“…CTN protocols, moreover, documented the value of treatments that incorporate medications (Amass et al, 2004;Ling et al, 2005) and use motivational incentives (contingency management) to reduce use of stimulants among methadone patients (Peirce et al, 2006) and to increase retention in care among stimulant users in outpatient services (Petry et al, 2005). The CTN Workforce survey, therefore, included items assessing opinions toward the use of evidence-based treatments including manualized treatment, medications, mental health services, and motivational incentives as well as support for the use of confrontation and discharge for non-compliance.…”