2.
Specific Aims Among the more than half million adults entering addiction treatment for prescription opioid abuse every year, 50%-60% report co-morbid chronic pain1-3 and 80% of those patients report that pain triggers use.4 Fifty- four percent of patients report pain after treatment for opioid use disorder, and patients with co-morbid chronic pain are 5 times more likely to relapse to opiate use than those without.5 Opioid use disorder accounts for 1/3 of all substance abuse treatment in the US. However, treatment for opioid addiction is failing; 80% of patients relapse to daily opioid use within 1 year9. Despite the prominent role of chronic pain in opioid addiction, no empirically-developed integrated treatments address these co-morbid functionally related problems.10-12 This R34 proposal, ?Advancing STOP: Self-regulation/CBT Therapy for Opioid addiction and Pain? in response to PA-13-078, ?Behavioral and Integrative Treatment Development Program,? seeks to modify and further evaluate our innovative Cognitive Behavioral Therapy (CBT)+Self Regulation group therapy protocol (Self-regulation/CBT Therapy for Opioid addiction and Pain: STOP) initially developed from PI?s NIDA K-23 human laboratory findings on the psychological and physiological responses to pain and opioid craving. The PI?s NIDA K23, entitled Co-morbid Opioid Addiction and Chronic Pain, used a human laboratory paradigm to identify the unique treatment needs of opioid addicted adults with chronic pain, including a need for an integrated treatment to improve both pain and craving tolerance (i.e. not just pain sensitivity), and to develop adaptive cognitive hyper-control and new automatic psycho-physiological craving trigger responses similar to the responses found among co-morbid pain and addiction patients who have maintained long-term opioid abstinence.6 The human laboratory findings6 derived in the first 3 years of the K23 were then used develop ?STOP,? the first iteration of an integrated group therapy treatment protocol designed to synergistically treat co-morbid opioid addiction and chronic pain over 12 weekly sessions to be used within the context of Medication Assisted Treatment in community addiction treatment centers. The model is thus designed to ease dissemination within existing community medication treatment models, Preliminary pre-post data from the K23 cohort of 14 subjects treated with STOP suggest high levels of acceptability of the protocol, improved pain tolerance, decreased cravings, and less drug use. In addition, subjects provided feedback to improve the protocol. The current R34 application is the next logical step to:1)modify the treatment manual and participant workbook based on the data derived from the initial K23 testing; 2)develop a clinician training protocol to train addiction counselors and treatment integrity measures which expands the K23 study in which the PI (Wachholtz) was the primary study therapist; 3)test the modified manual in a cohort of 10 subjects and modify once more if necessary, and 4)test the modified protocol in a Stage 1b Randomized Controlled Trial (RCT) with 50 subjects using primary outcomes of reduced opioid cravings and use, improved pain tolerance, and increased functional activity via mechanisms of improved pain and craving responses.
Four specific aims are proposed:
Specific Aim 1 (Stage 1a). Finalize the STOP therapist manual and participant workbook by merging quantitative and qualitative subject response data from the K23 pilot study to modify the initial K23 manual, and then test it on a 10 subject cohort. The protocol will then be refined again in response to subject feedback and quantitative data to yield a final 12-session, community friendly, stand alone, rolling entry psychotherapy manual that can be used within established substance abuse treatment delivery systems, and will simultaneously and integratively address therapeutic challenges of both chronic pain and addiction.
Specific Aim 2. Develop and field test a clinician training protocol for addiction counselors who have no prior expertise in pain management, as well as treatment integrity measures for the treatment manual.
Specific Aim 3 (Stage 1b). Complete small scale (N=50) Randomized Controlled Trial (RCT) comparing the new STOP protocol (n=25) to the current standard of care (?Treatment as Usual,? TAU; n=25) for opiate addiction in a sample of subjects with co-morbid opioid use disorder and chronic pain to establish initial effect sizes in preparation for a larger trial.13 TAU will include psychotherapy as provided by addiction providers; the STOP protocol will include STOP. There will be 3 assessment time points: pre-intervention, immediately post- intervention, and 1 month follow-up to assess for short term and longer term effects of the protocol.
Specific Aim 4. To preliminarily test a mediation path from increased use of adaptive cognitive and behavioral responses, to pain and addiction cravings, to increased pain tolerance, decreased cravings and increased engagement in daily activities, to reduced drug use for use in preparation for future research studies.
/Relevance Statement The public health relevance of this proposed project is substantial given the current opioid abuse epidemic as identified by the CDC 7, 8. This study finalizes and tests a novel psycho-physiological based psychotherapy treatment that is designed to simultaneously address co-morbid pain and opioid addiction in a format that could be easily used in a community addiction treatment setting. Final products of the study will yield an integrated STOP (CBT/Self-regulation) manual guided protocol, patient workbook, and therapist training protocol that are ready for fully powered testing in an R01 and subsequent dissemination in community settings.
