Development and testing of cognitive behavioral therapy for insomnia adapted for patients in opioid use disorder treatment

Opioid use disorder (OUD) is a leading cause of death in the United States, with overdose-related mortality rates remaining high nationally. Medications for OUD are life-saving, and increasing their utilization and reten-tion in treatments for OUD is the most effective pathway forward to combat this public health crisis. Comorbid conditions common among people with OUD, such as insomnia, hinder OUD treatment retention and benefit, rendering patients at persistent overdose risk. Insomnia is prevalent in over half of patients receiving medica-tion treatment for OUD, representing an ideal target for adjunctive treatments to medications for OUD aimed to improve health and recovery outcomes. Cognitive Behavioral Treatment for Insomnia (CBT-I) is considered the gold-standard treatment for insomnia, yet its evidence is limited in OUD populations. Historically, behavioral therapies integrated into OUD treatment have demonstrated improved effectiveness when they are adapted to patients’ specific needs. The objectives of this R34 application are to develop, refine, and preliminarily test the effects of a novel, integrated approach to treating insomnia in adults with comorbid opioid use disorder and in-somnia. We will develop, pilot test, and refine a Cognitive Behavioral Therapy for Insomnia and Opioid use dis-order, called CBT-IO. The proposed study will tailor CBT-I to OUD patient-reported needs and preferences gained from preliminary qualitative data. We will adapt the CBT-I content (OUD specific information, such as anchoring sleep schedules to administration of OUD medication) and its delivery (utilizing telehealth vs. in per-son options for sessions based on factors that impact treatment engagement). We will take a multi-disciplinary approach to the intervention’s development and testing, incorporating an expert panel review, as well as pa-tient pre-testing using both qualitative and quantitative methods to evaluate feasibility, acceptability, and en-gagement outcomes. We will then examine the preliminary effects of the newly developed and refined interven-tion in a sample (N=56) of adults with comorbid insomnia and OUD using a clinical trial design. Outcomes will include both sleep and substance use outcomes. Specific Aims include: AIM 1: Develop and refine a CBT-I intervention (CBT-IO) for individuals with OUD, which includes adapted content and a decision aid to guide in-dividualizing treatment delivery route (telehealth vs. in person) based on patient-reported factors that impact treatment engagement; AIM 2: Evaluate preliminary efficacy of CBT-IO to improve insomnia and OUD out-comes for individuals receiving medication treatment for their OUD. Results will inform large scale studies to determine best methods for treating insomnia and OUD in treatment seeking adults along with supporting NIDA’s goal of advancing personalized medicine in addictions.