A significant proportion of patients maintained on chronic opioid therapy for pain (COT-P) have suboptimal pain relief and/or poor functioning despite the appreciable risk of opioid treatment, including overdose death. There is a major gap in clinical knowledge regarding how to manage individuals on COT-P, especially those in need of opioid cessation. When an indication exists for discontinuation from COT-P, there is no empirical evidence as to how to approach opioid discontinuation or outcomes after opioid cessation. The long-term goal of this application is to expand the current knowledge about opioid discontinuation for those on COT-P. Buprenorphine, a partial mu-opioid receptor agonist, is well-suited for use in opioid tapering/detoxification settings, but there is a great need to evaluate the tolerability and effectiveness of buprenorphine for those on COT-P. Preliminary evidence suggests that buprenorphine induction is well-tolerated for those on COT-P, but tapering is challenging due to pain and withdrawal symptoms. The objectives of this application are to evaluate buprenorphine-assisted discontinuation from COT-P and to determine the role of gabapentin, an N-type calcium channel blocker, as an adjunctive agent to assist with opioid cessation. The central hypothesis of this study is that COT-P patients undergoing a buprenorphine taper with adjunctive gabapentin will have higher rates of opioid cessation when compared with those on buprenorphine/ placebo. Secondary hypotheses are that patients will have decreased pain after buprenorphine initiation and that those on adjunctive gabapentin will have lower withdrawal and pain scores when compared with placebo. To test these hypotheses, a two-phase study of buprenorphine-assisted opioid discontinuation will be conducted in 150 COT-P patients with an indication for opioid cessation.
The specific aims of this study are: (1) To determine the base rate of buprenorphine tolerability among COT-P subjects, and (2) To examine the efficacy of gabapentin in improving outcomes during a buprenorphine-assisted taper from COT-P. The primary outcome measures will be buprenorphine tolerance and opioid cessation. The rationale for the proposed research is to determine base rates and effect sizes to inform a larger randomized- controlled trial of the effects of gabapentin on opioid cessation during buprenorphine-assisted taper from COT-P. It is expected that a significant number subjects will tolerate buprenorphine, and that those randomized to gabapentin will have higher rates of opioid cessation when compared with placebo. Additionally, it is hypothesized that there will be significant differences in pre- to post- induction and taper levels of pain associated with opioid cessation. Resumption of opioid analgesic use at 1-, 3- and 6-months post-taper will be measured. Such results are expected to have a positive impact by identifying approaches to facilitate opioid cessation when indicated, thereby decreasing risk for prescription opioid overdose. This innovative study will be the first to systematically explore both buprenorphine and gabapentin during opioid tapering in COT-P patients who do not have addiction and the first to systematically evaluate pain before and after opioid discontinuation.
Many of the 9 million users of medical long-term opioid analgesics in the United States report suboptimal pain relief despite incurring risks, including overdose risk. When indications exist to discontinue opioids in this population, little research is available to guide clinicians in how to approach opioid cessation. This grant proposes to provide Dr. Kelly Barth career development in order to become an independent and expert researcher in the area of risk reduction for those on chronic opioid therapy for pain through evaluating opioid cessation approaches and outcomes in this population.
| Barth, Kelly S; Ball, Sarah; Adams, Rachel S et al. (2017) Development and Feasibility of an Academic Detailing Intervention to Improve Prescription Drug Monitoring Program Use Among Physicians. J Contin Educ Health Prof 37:98-105 |
| Barth, Kelly S; Guille, Constance; McCauley, Jenna et al. (2017) Targeting practitioners: A review of guidelines, training, and policy in pain management. Drug Alcohol Depend 173 Suppl 1:S22-S30 |
| Guille, Constance; Barth, Kelly S; Mateus, Julio et al. (2017) Treatment of Prescription Opioid Use Disorder in Pregnant Women. Am J Psychiatry 174:208-214 |
