Counseling and directly observed medication for primary care buprenorphine maintenance: a pilot study.

Physician office-based prescription of buprenorphine for opioid agonist maintenance treatment greatly expands treatment options and availability of services for opioid dependent individuals. Early studies established that buprenorphine in a primary care setting improved treatment outcomes and thus led to legislation authorizing its use (H. R. 4365, 2000). Of note, the majority of those early studies included drug counseling and directly observed medication consistent with methadone regulations of the time (Fiellin et al., 2002; Fudala et al., 2003; Johnson et al., 2000; Kosten et al., 1993; O’Connor et al., 1998; Schottenfeld et al., 1997). Despite this, few studies have directly evaluated level of counseling and observed medication in buprenorphine maintenance in primary care and current legislation does not require directly observed medication or specify the type or amount of counseling (but only provides the ability to refer patients to appropriate care). Although psychosocial counseling has been shown to improve outcomes among patients receiving methadone (Abbott et al., 2003; Hayes et al., 2004; McLellan et al., 1993; Woody et al., 1995), findings in patients receiving buprenorphine have been less clear. Several studies have shown that counseling (Community Reinforcement Approach or Behavioral Drug Counseling) with contingent vouchers improves treatment outcome compared to standard treatment (Bickel et al., 2008; Chawarski et al., 2008). One study directly compared level of nurse provided counseling in office-based primary-care buprenorphine, but was unable to detect a differences between brief and extended counseling (Fiellin et al., 2006). However this study, as well as those above, included individual weekly counseling in the comparison condition. Despite these findings no studies have compared counseling without vouchers to a no counseling or physician brief counseling condition (Arfken et al., 2010). An important consideration in evaluating counseling for buprenorphine maintenance is the feasibility of coordinating psychosocial services in primary care offices in a time and cost-efficient manner. The previously referenced study (Fiellin et al., 2006) used nurses to provide counseling since they are readily available in primary care, less expensive than physicians, and familiar with medical settings. An alternative to this approach is onsite counseling provided by a trained professional. Cognitive Behavioral Therapy (CBT) is an empirically supported psychosocial intervention for a variety of psychiatric disorders (McGinn, 2000; Olatunji et al., 2010), has a strong evidence base supporting its efficacy for treating addictive disorders, and has demonstrated durability of treatment effects (Budney et al., 2007; Carroll et al., 2008; Carroll, Rounsaville, Nich et al., 1994; Lee & Rawson, 2008; Longabaugh & Morgenstern, 1999). CBT for addictive disorders is often provided in 12 weekly, one hour, individual sessions by specialized therapists, although group CBT is also common. One pilot study evaluated CBT in the context of opioid agonist maintenance (Abrahms, 1979), showing improvement in secondary clinical outcomes such as anxiety and depression, but to our knowledge no study has evaluated the feasibility and acceptability of providing CBT for opioid agonist maintenance in a primary care context. Buprenorphine dosing research has established that withdrawal effects, intoxication and adverse medical effects are similar across daily, alternate day, or every 3-day observed dosing (Amass et al., 1998; Bickel et al., 1999). Clinical outcomes of retention and drug use have also shown similar rates between daily and thrice-weekly observed dosing (Schottenfeld et al., 2000). Similarly, provision of weekly dispensing of daily medication has shown similar clinical outcomes to more frequent dispensing (Bell et al., 2007; Fiellin et al., 2006). Notably, in one study, patients with higher levels of documented medication adherence had improved buprenorphine treatment outcomes (Fiellin et al., 2006). Given potential problems associated with buprenorphine diversion, additional evaluation of observed versus dispensed dosing is needed (Dasgupta et al., 2010; Vicknasingam et al., 2010). The current study was designed to evaluate feasibility, acceptability, and initial efficacy of therapist provided CBT counseling with directly observed medication administration compared to physician management only with weekly provision of medication.