A multi-site, two-phase, Prescription Opioid Addiction Treatment Study (POATS): Rationale, design, and methodology

Division of Alcohol and Drug Abuse, McLean Hospital, 115 Mill Street, Belmont, MA 02478, United States.
Contemporary clinical trials (Impact Factor: 1.94). 03/2010; 31(2):189-99. DOI: 10.1016/j.cct.2010.01.003
Source: PubMed


The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age > or =18 who met Diagnostic and Statistical Manual, 4th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (bup/nx). Phase 1 consisted of 4 weeks of bup/nx treatment, including a 14-day dose taper, with 8 weeks of follow-up. Phase 1 participants were monitored for treatment response during these 12 weeks. Those who relapsed to opioid use, as defined by pre-specified criteria, were invited to enter Phase 2; Phase 2 consisted of 12 weeks of bup/nx stabilization treatment, followed by a 4-week taper and 8 weeks of post-treatment follow-up. Participants were randomized at the beginning of Phase 1 to receive bup/nx, paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual drug counseling). Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study.

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Available from: Jennifer Potter, Jul 22, 2014
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    • "Albeit reviewed studies were heterogeneous in both design and participant characteristics, mean relapse rate consistently surpassed 50%. Notably, high relapse rates were observed in young adults (Woody et al., 2008) as well as primary prescription opioid abusers (Sigmon et al., 2013; Weiss et al., 2010), populations often considered to be have better prognoses (Dreifuss et al., 2013; Moore et al., 2007; Sigmon, 2006). Given the association between perceived risk of relapse and interest in remaining in (Winstock et al., 2011) or initiating (Bailey et al., 2013) agonist medications, it will be important to remind all opioid-dependent, buprenorphine-maintained patients of the high probability of relapse before they consent to terminating treatment. "
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    ABSTRACT: Buprenorphine maintenance therapy (BMT) is increasingly the preferred opioid maintenance agent due to its reduced toxicity and availability in an office-based setting in the United States. Although BMT has been shown to be highly efficacious, it is often discontinued soon after initiation. No current systematic review has yet investigated providers’ or patients’ reasons for BMT discontinuation or the outcomes that follow. Hence, provider and patient perspectives associated with BMT discontinuation after a period of stable buprenorphine maintenance and the resultant outcomes were systematically reviewed with specific emphasis on pre-buprenorphine-taper parameters predictive of relapse following BMT discontinuation. Few identified studies address provider or patient perspectives associated with buprenorphine discontinuation. Within the studies reviewed providers with residency training in BMT were more likely to favor long term BMT instead of detoxification, and providers were likely to consider BMT discontinuation in the face of medication misuse. Patients often desired to remain on BMT because of fear of relapse to illicit opioid use if they were to discontinue BMT. The majority of patients who discontinued BMT did so involuntarily, often due to failure to follow strict program requirements, and 1 month following discontinuation, rates of relapse to illicit opioid use exceeded 50% in every study reviewed. Only lower buprenorphine maintenance dose, which may be a marker for attenuated addiction severity, predicted better outcomes across studies. Relaxed BMT program requirements and frequent counsel on the high probability of relapse if BMT is discontinued may improve retention in treatment and prevent the relapse to illicit opioid use that is likely to follow BMT discontinuation.
    Full-text · Article · Dec 2014 · Journal of Substance Abuse Treatment
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    • "We used this item as an indirect proxy for craving, due to the possibility that asking directly about craving in this sample might elicit defensive responding or denial. Single item measures of craving have been shown to distinguish high-from low-risk opioid using chronic pain patients and predict opioid misuse (Wasan et al., 2009; Weiss et al., 2010). "
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    ABSTRACT: Objective: Opioid pharmacotherapy is now the leading treatment for chronic pain, a problem that affects nearly one third of the U.S. population. Given the dramatic rise in prescription opioid misuse and opioid-related mortality, novel behavioral interventions are needed. The purpose of this study was to conduct an early-stage randomized controlled trial of Mindfulness-Oriented Recovery Enhancement (MORE), a multimodal intervention designed to simultaneously target mechanisms underpinning chronic pain and opioid misuse. Method: Chronic pain patients (N = 115; mean age = 48 ± 14 years; 68% female) were randomized to 8 weeks of MORE or a support group (SG). Outcomes were measured at pre- and posttreatment, and at 3-month follow-up. The Brief Pain Inventory was used to assess changes in pain severity and interference. Changes in opioid use disorder status were measured by the Current Opioid Misuse Measure. Desire for opioids, stress, nonreactivity, reinterpretation of pain sensations, and reappraisal were also evaluated. Results: MORE participants reported significantly greater reductions in pain severity (p = .038) and interference (p = .003) than SG participants, which were maintained by 3-month follow-up and mediated by increased nonreactivity and reinterpretation of pain sensations. Compared with SG participants, participants in MORE evidenced significantly less stress arousal (p = .034) and desire for opioids (p = .027), and were significantly more likely to no longer meet criteria for opioid use disorder immediately following treatment (p = .05); however, these effects were not sustained at follow-up. Conclusions: Findings demonstrate preliminary feasibility and efficacy of MORE as a treatment for co-occurring prescription opioid misuse and chronic pain. (PsycINFO Database Record (c) 2014 APA, all rights reserved).
    Full-text · Article · Feb 2014 · Journal of Consulting and Clinical Psychology
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    • "Furthermore, prescription opioids are among the most commonly used drugs at initiation into illicit drug use -second only to marijuana (SAMHSA, 2010a). Initiation into prescription opioid misuse is an important public health concern since opioids are increasingly associated with drug dependence (SAMSHA, 2008a; Weiss et al., 2010) and fatal overdose (Paulozzi & Xi, 2008; SAMSHA, 2010b). "
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