Co-occurring chronic pain and opioid dependence (POD) is a challenging clinical problem that undermines the effectiveness of office-based buprenorphine maintenance treatment (BMT). This application proposes to to develop and evaluate a cognitive-behavioral treatment for POD (CBT for POD) that would be feasible to provide by nurses, acceptable to patients, and efficacious for reducing pain and drug use outcomes in office-based BMT. CBT for POD is based on 5 CBT pain modules with the strongest empirical support in non-addict populations and of greatest relevance to patients with POD. These modules include: 1) Education to provide a rationale for the other specific CBT modules;2) Cognitive Control to identify and challenge dysfunctional cognitive errors (e.g., catastrophizing);3) Exercise and Behavioral Activation to counter deconditioning and increase flexibility and social functioning;4) Coping with Pain or Craving without illicit drug use;and 5) Relaxation Training. This Stage IB application proposes 3 phases of psychotherapy development. In Phase 1, we will train 2 psychologists and 2 nurses to provide manual-guided CBT for POD and 2 psychologists and 2 nurses to provide the comparison treatment (manual-guided Educational Counseling, EC), supervise their treatment of 2 training cases each, and revise the therapy manuals, if indicated based on the training cases. In Phase 2, we will conduct a pilot randomized clinical trial (RCT) of office-based BMT comparing CBT for POD and EC. EC is matched to CBT for POD in number and frequency of individual sessions and uses a didactic lecture-discussion format to educate the patient about core topics about back pain causes and treatments (3 modules) and opioid addiction and treatment (2 modules). Following a 2-week buprenorphine induction/stabilization, patients (N=60) with persistent non-specific low back pain (pain ratings e 4 on a 0-10 numeric rating scale) will be maintained on a stable daily buprenorpine dose for 12 weeks and randomly assigned to manual- guided CBT for POD or EC. Primary outcome measures include reductions in pain intensity and in frequency (days per week) of illicit opioid use. Secondary outcome measures include treatment retention, longest duration of consecutive abstinence from illicit opioids, and improvement in emotional, physical and global functioning. Data analyses will focus on an intention-to-treat sample of all randomized patients and are intended to evaluate the effect size of the differences in outcomes between CBT for POD and EC. In Phase 3, we will make final revisions of the CBT for POD and EC manuals and training materials,if needed, incorporate clinical examples in the CBT for POD manual, and ensure that the training procedures are attentive to the different intervention styles and skill sets of different professionals who might be serving patients in a broad range of medical settings. If the study findings support the feasibility and potential efficacy of CBT for POD, a subsequent Stage II clinical trial with a larger sample size would be warranted.
Relevance: The recent introduction of physician-prescribed buprenorphine for opioid agonist maintenance treatment (BMT) in office-based medical settings provides a unique opportunity to coordinate addiction and pain management treatment for patients with co-occurring chronic pain and opioid dependence (POD), but patients with POD have greater treatment attrition and higher levels of continuing illicit opioid use during BMT than patients without co-occurring chronic pain. Development and evaluation of an effective cognitive-behavioral therapy that targets the interrelated problems of pain and opioid dependence for patients with POD treated with BMT and that could be provided by primary care or office-based nurses, as planned in this study, would facilitate improved treatment for POD in office-based BMT. .
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