Mark A. Ilgen, Ph.D. - US grants

DESCRIPTION (provided by applicant): Suicide, with its related mortality and morbidity, represents a significant and preventable loss of human life. Existing research indicates that problematic alcohol and drug use are closely linked to both fatal and non-fatal suicide attempts. Given the strong association between substance use and suicide, an episode of substance use disorder (SUD) treatment provides a unique opportunity to decrease the likelihood of suicidal behaviors. However, there are no data on the effectiveness of specific interventions designed to decrease risk of suicidal thoughts and behaviors during an episode of SUD treatment in individuals at high risk for suicide. The proposed 2-year study will: (1) adapt and refine an existing cognitive-behavioral treatment (CBT) intervention designed to decrease suicidal thoughts and behaviors for use in SUD treatment settings;and (2) conduct a pilot randomized controlled trial with 50 patients in treatment for SUDs comparing the CBT intervention to usual care. This pilot randomized controlled trial will: (a) obtain information about the feasibility of these procedures in residential SUD treatment;(b) determine the distribution and variability of the primary (level of suicidal ideation) and secondary outcomes (suicide attempts, hopelessness, frequency of substance use) within intervention and control conditions. The strong existing data on the efficacy of the CBT intervention for use in other settings, combined with our prior knowledge of modifying interventions for individuals with SUDs, will allow us to progress quickly from the initial intervention modification process to conducting a pilot randomized controlled trial of this intervention. Patients will be screened at SUD treatment entry for a combination of a past suicide attempt and current suicidal ideation and will be randomized to CBT or control conditions. All participants in the pilot randomized controlled trial will be assessed at baseline, at the end of treatment, and at 3-month follow-up. From a public health perspective, SUD treatment programs contain large numbers of patients at high risk for future suicidal behaviors and therefore have the potential to play a central role in our nation's efforts to decrease suicide. The proposed project is the first step in our planned line of research intended to decrease the likelihood of suicidal thoughts and behaviors in individuals with SUDs and will provide all of the essential elements needed to design a large RCT in the future that is fully powered to test the impact of this intervention on post-treatment suicidal thoughts and behaviors in this high risk population. PUBLIC HEALTH RELEVANCE: The purpose of this project is to adapt an existing Cognitive-Behavioral Therapy (CBT) protocol to reduce suicidal thoughts and behaviors during an episode of substance use disorder treatment. The study will involve a pilot randomized controlled trial comparing this adapted CBT intervention to usual care in suicidal patients recruited from a residential substance use disorder treatment program in order to determine the distribution and variability of the primary and secondary outcomes within the intervention and control conditions.

DESCRIPTION (provided by applicant): Chronic pain among individuals with Substance Use Disorders (SUDs) is a common and critically important problem that is rarely managed appropriately. The estimated rates of chronic pain in patients who are in SUD treatment are as high as 60 percent, with many patients reporting long-lasting and significant pain during treatment. The treatment of pain is complicated in those with SUDs because of the potential for abuse and diversion of many prescription pain medications. Furthermore, recent evidence suggests that untreated pain may undermine the effectiveness of standard treatments for SUDs. An important potential strategy is the use of cognitive behavioral therapy (CBT) to both manage pain and decrease substance use/misuse. Psychosocial interventions such as CBT have demonstrated efficacy for reducing pain and improving functioning in persons with a broad spectrum of pain-related problems, but have not been evaluated in those with SUDs. Thus, SUD treatment providers are left without successful and empirically-supported methods for treating the large number of patients with chronic pain who also have SUDs. The proposed study is a randomized controlled efficacy trial of a group-based intervention that integrates CBT for pain and SUDs compared to a Supportive Psychoeducation Control (SPC) group in a sample of patients in SUD treatment with co-occurring chronic pain. A total of 452 patients (226 male and 226 female) with current pain rated as moderate or greater will be recruited from a large residential SUD treatment facility. These participants will be randomly assigned to either a 4-week (8-session) group of integrated CBT for pain and SUDs or a 4-week (8-session) SPC group. All participants will be re-assessed immediately post-intervention completion (around 1-month) and at 3-, 6-, and 12- months after the intervention. The primary specific aims will focus on pain (level, tolerance and pain-related disability) and substance use (frequency of drug, alcohol and opioid medication misuse) outcomes. Secondary analyses will explore: 1) whether change in pain during the intervention mediates the effect of CBT on subsequent substance use/misuse; 2) other hypothesized mechanisms of action for the CBT intervention; and 3) the impact of the intervention on HIV risk behaviors and depressive symptoms. Mixed model regression analyses will be used for all primary aims, within each gender, to estimate between-group differences in changes in outcomes over time. Currently, treatment providers lack evidence-based interventions to address pain in individuals with SUDs. Improving the treatment of pain in patients with SUDs could have a wide-ranging impact not only on individuals' pain, but also on their substance use and quality of life. Knowledge generated in the proposed study is likely to have broad implications for the care of patients with pain and SUDs in many different healthcare settings. PUBLIC HEALTH RELEVANCE: The proposed project will determine the efficacy of a cognitive-behavioral pain management intervention targeting individuals with co-occurring pain and substance use disorders who will be recruited at the start of a residential treatment episode. This proposed efficacy study will provide crucial data on a brief, innovative method designed to improve outcomes in the large numbers of individuals with both substance use disorders and chronic pain.

DESCRIPTION (provided by applicant): Marijuana is the most frequently used drug in the United States and has been linked to numerous negative outcomes. However, many individuals also perceive marijuana to be beneficial for the treatment of chronic pain. Although evidence for the long-term analgesic effects of marijuana is still preliminary, 15 states have legalized the use of marijuana for medical purposes, including pain relief. To date, even basic data are lacking on the characteristics of those who use medical marijuana and how substance use and substance use-related problems change after obtaining medical marijuana. Similarly, access to medical marijuana may influence an individual's experience of pain, HIV risk profile, functioning, and health service use. With the ongoing policy debate and growing popularity of medical marijuana programs in the United States, it is essential to understand the potential ramifications of medical marijuana use for individuals who seek access to it. The proposed study will screen individuals seeking to obtain medical marijuana at one of four medical marijuana clinics in Southern Michigan. Based on responses to this screen, the proposed project will identify a cohort of 800 individuals (400 men and 400 women) who are seeking medical marijuana for the first time for reasons related to pain. This cohort will be re-assessed at 6-month intervals for 2 years in order to adequately measure the longer-term changes in levels of mental and physical functioning, employment and legal functioning, and health service use outcomes. Initial analyses will utilize the screening data to examine baseline differences in substance use, pain, HIV risk profile, functioning, and service use between those seeking a medical marijuana card for the first time and those seeking to renew their medical marijuana card. Subsequent analyses will model substance use (marijuana and other drug use), pain (pain level and behavioral pain tolerance), HIV risk profile, functioning (mental, physical, employment, and legal functioning), and health service (specialty pain treatment, addictions treatment, and general medical care) utilization over the course of 2 years after a first visit to a medical marijuana clinic for pain treatment. We will also identify factors that predict longer-term trajectories of substance use, pain, functionin, and health service use. As a secondary objective, we will examine the scope of medical marijuana diversion and the characteristics of participants who engage in medical marijuana diversion over time. This project will provide crucial data on individuals seeking medical marijuana for pain management and how these individuals change over time. The resulting data will inform the debate surrounding medical marijuana use and could help shape strategies to identify and intervene with individuals at risk for problems related to substance use.

ABSTRACT Individuals with Alcohol Use Disorders (AUDs) are at significantly elevated risk for fatal and non-fatal suicide attempts. This is seen in higher rates of suicide mortality in those diagnosed with an AUD as well as the high rates of prior suicidal behaviors and/or current suicidal ideation among of patients treated for AUDs. This elevated risk persists following AUD treatment. In addition, those with AUDs are prone to impulsive suicide attempts, those attempts that occur with less than 30 minutes planning, and can lead to rapid escalation in risk, particularly when under the influence of alcohol. New and effective strategies are needed to reduce suicide risk among those with AUDs and should be tailored to the unique risks in those with AUDs. The National Suicide Prevention Lifeline (NSP Lifeline) was established by Substance Abuse and Mental Health Services Administration (SAMHSA) to increase consistency in delivery of services. SAMHSA also implemented follow up procedures with treatment referrals for NSP Lifeline callers. Since its inception, the NSP Lifeline has received > 5 million calls. However, no data are currently available on whether use of the NSP Lifeline reduces an individual's likelihood of a suicide attempt or death and it is not feasible to test the efficacy of the Crisis Line in a randomized controlled trial because it is already nationally available. Additionally, the NSP Lifeline may not reach those individuals at most acute risk for suicide. Consequently, we developed and gathered pilot data on a brief intervention designed to increase utilization of crisis lines among high risk patients, called Crisis Line Facilitation (CLF). This single-session intervention involves a discussion of the patient's perceived barriers and facilitators of crisis line use during periods of suicidal crisis. The CLF session ends with the patient calling the NSP Lifeline with the therapist in the room as a way for them to practice the logistics of making the call and to have direct experiences that may counter any negative beliefs about crisis line use. The proposed study will recruit 500 participants who are currently receiving residential AUD treatment and have made a prior suicide attempt. This study will be a randomized controlled trial of the impact of CLF compared to enhanced usual care (EUC) on utilization of the NSP Lifeline as well as suicide attempt(s). All participants will be re-assessed at post-intervention, 4-, 8- and 12-months post baseline. Analyses will also examine the extent to which lifetime changes in the proposed mechanisms of action of CLF explain the effects of CLF on calls to the NSP Lifeline and suicide attempts as we as whether post-baseline NSP Lifeline use mediates the effect or random assignment to CLF on subsequent suicidal behaviors. If successful, the proposed study will provide key data on the potential efficacy of a brief tool to improve the utilization of an existing resource, the NSP Lifeline, to reduce suicidal behaviors in adults receiving treatment for AUDs. Developing a brief and effective approach to encourage use of NSP Lifeline has the potential to have a substantial impact on suicide rates and could be modified and exported to other populations and settings.

ABSTRACT Developing new strategies to address pain in patients with opioid use disorder (OUD) is critical to improving outcomes for the large population of patients with comorbid chronic pain and OUD. With the national opioid epidemic, which has been propelled by overuse of opioids for pain, efforts are underway to increase access to medication assisted treatment (MAT), especially with the medication buprenorphine. However, many individuals who receive MAT leave treatment early and continue to struggle with opioid use, often within the context of poorly-managed comorbid chronic pain. New strategies to help patients cope with and adapt to chronic pain are urgently needed. Psychosocial interventions for pain have been effective in patients with chronic pain and substance use disorders, but these interventions have not been examined in the OUD population receiving MAT. Our team received a SAMHSA State Targeted Response to Opioid Crisis grant to help providers increase delivery of MAT in Southeast Michigan. Providing alternative pain treatment options has the potential to be an important component delivering effective MAT. The purpose of this study is to refine and adapt a psychosocial pain management intervention (PPMI) to be delivered by telephone for patients with OUD receiving MAT and then to conduct a randomized controlled trial of the intervention in patients receiving MAT to improve OUD adherence and pain- and substance-related outcomes. The intervention uses elements of cognitive behavioral pain management interventions adapted specifically for patients with OUD receiving MAT. This new intervention will be compared to an enhanced usual care condition (EUC). The study will recruit 100 patients with OUD and comorbid pain receiving MAT in clinics in southeast Michigan. The specific aims are: R21 Specific Aim 1: Using qualitative patient interviews, adapt a telephone-based PPMI and enhanced usual care (EUC) condition to address the needs of individuals with pain and OUD receiving MAT. R21 Specific Aim 2: Iteratively refine the PPMI and EUC informed (1) by beta-testing with patients with OUD and chronic pain and (2) by expert opinion. R33 Specific Aim 1: Conduct a pilot RCT comparing a telephone-based PPMI approach (n=50) to EUC (n=50) to assess the impact of randomization to PPMI on retention to MAT (primary outcome). R33 Specific Aim 2: Determine the impact of the PPMI on pain level, pain-related functioning, and frequency of opioid use (secondary outcomes). Knowledge generated in this study will have important implications for improving outcomes for patients with OUD and chronic pain through increased understanding of effective patient-focused psychosocial strategies to help patients better manage pain. Ultimately, this line of research has the potential to lead to reductions in morbidity and mortality among the large number of patients suffering from OUD and chronic pain.

Project Summary/Abstract In recent years, the movement to promote the legalization of medical cannabis has grown in the United States and now 29 States and the District of Columbia have provisions that allow for the use of cannabis for medical reasons. Irrespective of the specific reasons for seeking medical cannabis, adults who have been evaluated for medical cannabis certification report significant sleep-related problems as well as frequent use of cannabis to address their sleep problems. Cannabis use for sleep is a key potential target for interventions given that prior research has found that, among individuals with cannabis use disorders, poor sleep is a barrier to sustained remission from cannabis use. Cognitive Behavioral Therapy (CBT) for insomnia is highly effective in individuals with insomnia comorbid with other health conditions, including substance use disorders; however, existing efficacy trials have not specifically evaluated its benefit in those who use cannabis for insomnia. The impact of CBT for insomnia on either sleep or cannabis use in medical cannabis users is, therefore, unknown. The objectives of this project are to adapt and tailor a telephone-delivered CBT for insomnia for adults who use medical cannabis (CBTi-CB) and to evaluate the acceptability and feasibility of this intervention. Qualitative and quantitative data will be collected to refine an existing CBTi-CB protocol and conduct a pilot test of the modified intervention in adults who use medical cannabis. Adults seeking certification for medical cannabis will be approached while waiting for their appointment and screened for insomnia as well as cannabis use for sleep. After initial qualitative interviews and beta testing, eligible participants (N = 40) will be randomized to CBTi-CB or Sleep Education Control (SE) condition, delivered over the telephone. Participants will provide self- report data on sleep/insomnia, functioning and cannabis use and objective data on sleep quality will be measured by actigraphy. The study will evaluate changes in self-reported and objectively measured sleep, functioning and frequency/quantity of cannabis use during treatment and over the course of 18-weeks post- baseline. Completion of the study aims will provide all of the elements required for a future fully-powered randomized trial of the longer-term efficacy of CBTi-CB among those with medical cannabis. This line of research would be the first to evaluate a highly effective sleep-focused intervention and determine the effects on sleep-related and non-sleep-related cannabis use in a non-treatment seeking population.