Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol.

BACKGROUND: The majority of adults suffering from alcohol use disorders (AUD) do not receive treatment. To address this gap in care, we must develop new models to increase identification, engagement and delivery of accessible and effective treatment. This paper describes the protocol for a randomized controlled trial (RCT) testing a novel telehealth treatment model for primary care patients with untreated AUD. METHODS: We aim to recruit 300 adults across 2 healthcare systems for this two-arm RCT. Participants, initially identified for recruitment based on AUD-related indicators in their electronic health record (EHR), are RCT-eligible if they meet AUD criteria (mild, moderate, severe), report ≥ 3 drinking days/week in past 30 days, and have not received AUD psychotherapy in the past 90 days. Participants are randomized to an intervention or enhanced usual care control (EUC) condition, both individually-delivered. The intervention includes a telephone-delivered motivational interviewing (MI) engagement session and 8 sessions of MI-Cognitive Behavioral Therapy (MI-CBT). EUC involves AUD psychoeducation, advice to reduce drinking and seek treatment, and provision of community resources. Outcomes will be measured at 3-, 6-, and 12-months; primary outcomes include: AUD psychotherapy initiation and engagement (within the study and external community) and alcohol consumption (percent drinking days and heavy drinking days). CONCLUSIONS: This study addresses whether proactive patient identification and engagement and delivery of patient-centered telehealth psychotherapy to patients with untreated AUD is effective in increasing treatment use and improving alcohol outcomes. If effective, this could be a highly scalable model for reducing the public health impact of AUD. TRIAL REGISTRATION: ClinicalTrials.gov # NCT05410561. University of Michigan HUM00204315. Ann Arbor VA IRB #1655886.

A remote brief intervention plus social media messaging for cannabis use among emerging adults: A pilot randomized controlled trial in emergency department patients.

INTRODUCTION: Interventions addressing cannabis use among emerging adults (ages 18-25) are currently needed to prevent negative outcomes. Emergency Department (ED) visits provide an opportunity to initiate interventions. In this pilot study, we created a brief intervention (BI), extended with private social media messaging for emerging adult ED patients who use cannabis regularly. Study aims were to examine intervention feasibility, acceptability, and descriptive outcomes. METHODS: We recruited and randomized N = 58 emerging adults (M age 21.5 years, 65.5% female) who used cannabis from an ED in-person and remotely after their ED visit (given COVID-19 restrictions). Participants randomized to the intervention (N = 30) received a Motivational Interviewing-based BI and 4 weeks of health coaching via private social media; control participants received a resource brochure and entertaining social media messaging. Follow-ups occurred at 1-month and 3-months. RESULTS: Most intervention participants liked the BI (95.8%), found it helpful to discuss cannabis use in the BI (91.7%), and liked interacting with coaches on social media (86.3%). Social media content (e.g., video clips, images/still pictures/memes) were highly rated. Descriptively, the intervention group showed theory-consistent changes in importance of and intentions to change cannabis (increases vs. decrease/stability in control group), whereas findings for cannabis consumption/consequences were mixed. CONCLUSIONS: This BI paired with social media messaging was acceptable in a sample of emerging adults from an ED who used cannabis regularly. Despite feasibility challenges due to COVID-19, this intervention warrants future investigation with a larger sample and longer follow-up period, with attention to the changing cannabis landscape when measuring outcomes.

Adaptive interventions for alcohol misuse and violent behaviors among adolescents and emerging adults in the emergency department: A sequential multiple assignment randomized controlled trial protocol.

Alcohol use and violent behaviors among youth are associated with morbidity and mortality. An emergency department (ED) visit provides an opportunity to initiate prevention efforts. Despite promising findings from our single session SafERteens brief intervention (BI), impact is limited by modest effect sizes, with data lacking on optimal boosters to enhance effects. This paper describes the protocol for a sequential, multiple assignment, randomized trial (SMART). Adolescents and emerging adults (ages 14-20) in the ED screening positive for alcohol use and violent behaviors (physical aggression) were randomly assigned to: 1) SafERteens BI + Text Messaging (TM), or 2) SafERteens BI + remote Health Coach (HC). Participants completed weekly surveys over 8 weeks after the ED visit to tailor intervention content and measure mechanisms of change. At one-month, intervention response/non-response is determined (e.g., binge drinking or violent behaviors). Responders are re-randomized to continued intervention condition (e.g., maintenance) or minimized condition (e.g., stepped down). Non-responders are re-randomized to continued condition (e.g., maintenance), or intensified condition (e.g., stepped up). Outcomes were measured at 4 and 8 months, including primary outcomes of alcohol consumption and violence, with secondary outcomes of alcohol consequences and violence consequences. Although the original goal was to enroll 700 participants, COVID-19 impacts on research diminished recruitment in this trial (enrolled n = 400). Nonetheless, the proposed SMART is highly innovative by blending real-time assessment methodologies with adaptive intervention delivery among teens with comorbid alcohol misuse and violent behaviors. Findings will inform the content and timing booster interventions to alter risk behavior trajectories. Trial Registration:ClinicalTrials.govNCT03344666. University of Michigan # HUM00109156.

A randomized controlled trial of social media interventions for risky drinking among adolescents and emerging adults.

PURPOSE: Alcohol use among adolescents and emerging adults is an important public health issue requiring prevention approaches. Herein, we describe outcomes from a randomized controlled trial testing the efficacy of group-based social media interventions targeting risky drinking among youth. PROCEDURES: Using social media advertisements to screen potential participants, we recruited 955 youth (ages 16-24) reporting recent risky drinking. After completing a baseline assessment, participants were randomized to 8-week secret Facebook group conditions: Social Media Intervention + Incentives for engagement, Social Media Intervention only, and attention-placebo control. Electronic coaches trained in motivational interviewing facilitated interaction in intervention groups. Primary outcomes include past 3-month alcohol use and consequences over 3-, 6-, and 12-month follow-ups. Secondary outcomes include other drug use, consequences, and impaired driving. We also measured intervention engagement and acceptability. RESULTS: The interventions were well-received, with significantly greater acceptability ratings and engagement in the SMI+I condition relative to other groups. In adjusted analyses, there were no significant differences between interventions and control on alcohol-related outcomes, with all groups showing reductions. Regarding secondary outcomes (70.4% used other drugs), compared to control, the incentivized group reduced other drug use, consequences, and cannabis-impaired driving; the non-incentivized group did not significantly differ from the control condition. CONCLUSIONS: Among this predominantly poly-substance using sample, findings were mixed, with significant effects of the incentivized social media intervention on drug (but not alcohol) outcomes. Future studies are needed to further refine social media-delivered interventions to reduce alcohol and other drug use. TRIAL REGISTRATION: ClinicalTrials.gov NCT02809586; University of Michigan HUM#00102242.

Optimizing scalable, technology-supported behavioral interventions to prevent opioid misuse among adolescents and young adults in the emergency department: A randomized controlled trial protocol.

Preventing opioid misuse and opioid use disorder is critical among at-risk adolescents and young adults (AYAs). An Emergency Department (ED) visit provides an opportunity for delivering interventions during a rapidly changing opioid landscape. This paper describes pilot data and the protocol for a 2 × 2 factorial randomized controlled trial testing efficacy of early interventions to reduce escalation of opioid (prescription or illicit) misuse among at-risk AYAs. Interventions are delivered using technology by health coaches. AYAs ages 16-30 in the ED screening positive for prescription opioid use (+ ≥ 1 risk factor) or opioid misuse will be stratified by risk severity, sex, and age group. Participants will be randomly assigned to a condition at intake, either a live video health coach-delivered single session or a control condition of an enhanced usual care (EUC) community resource brochure. They are also randomly assigned to one of two post-intake conditions: health coach-delivered portal-like messaging via web portal over 30 days or EUC delivered at 30 days post-intake. Thus, the trial has four groups: health coach-delivered session+portal, health coach-delivered session+EUC, EUC + portal, and EUC + EUC. Outcomes will be measured at 3-, 6-, and 12-months. The primary outcome is opioid misuse based on a modified Alcohol Smoking and Substance Involvement Screening Test. Secondary outcomes include other opioid outcomes (e.g., days of opioid misuse, overdose risk behaviors), other substance misuse and consequences, and impaired driving. This study is innovative by testing the efficacy of feasible and scalable technology-enabled interventions to reduce and prevent opioid misuse and opioid use disorder. Trial Registration:ClinicalTrials.gov University of Michigan HUM00177625 NCT Registration: NCT04550715.

Social Media Interventions for Risky Drinking Among Adolescents and Emerging Adults: Protocol for a Randomized Controlled Trial.

BACKGROUND: Despite intervention efforts to date, the prevalence of risky drinking among adolescents and emerging adults remains high, increasing the risk for health consequences and the development of alcohol use disorders. Peer influences are particularly salient among this age group, including via social media. Thus, the development of efficacious early interventions for youth, delivered with a broad reach via trained peers on social media, could have an important role in addressing risky drinking and concomitant drug use. OBJECTIVE: This paper describes the protocol of a randomized controlled trial (RCT) testing the efficacy of a social media intervention among adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]), delivered with and without financial incentives for participation, compared with an attention placebo control condition (ie, entertaining social media content), on alcohol consumption and consequences. METHODS: This RCT involved recruiting 955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey. Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ≥3 females and ≥4 males; and ages 18-24 years: ≥4 females and ≥5 males) were eligible for the RCT. After providing consent (a waiver of parental consent was obtained for minors), participants completed a web-based baseline survey and several verification procedures, including a selfie photo matched to Facebook profile photos. Participants were then randomized to join invitation-only secret Facebook groups, which were not searchable or viewable by parents, friends, or anyone not recruited by the study. The 3 conditions were social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control. Each condition lasted 8 weeks and consisted of bachelor's-level and master's-level therapist electronic coaches posting relevant content and responding to participants' posts in a manner consistent with Motivational Interviewing. Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions. Follow-ups are ongoing and occur at 3, 6, and 12 months poststart of the groups. RESULTS: We enrolled 955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT. CONCLUSIONS: The findings of this study will provide the critical next step in delivering early alcohol interventions to the youth, capitalizing on social media platforms, which could have significant public health impact by altering alcohol use trajectories of adolescents and emerging adults engaged in risky drinking. TRIAL REGISTRATION: ClinicalTrials.gov NCT02809586; https://clinicaltrials.gov/ct2/show/NCT02809586. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16688.

Factors associated with alcohol consumption among medical cannabis patients with chronic pain.

INTRODUCTION: Chronic pain is the most common reason for medical cannabis certification. Data regarding alcohol use and risky drinking among medical cannabis patients with pain is largely unknown. Therefore, we examined the prevalence and correlates of alcohol use and risky drinking in this population. METHODS: Participants completed surveys regarding demographics, pain-related variables, anxiety, cannabis use, and past six-month alcohol consumption. Alcohol use groups were defined using the AUDIT-C [i.e., non-drinkers, low-risk drinkers, and high-risk drinkers (≥4 for men and ≥3 for women)] and compared on demographic characteristics, pain measures, anxiety, and cannabis use. RESULTS: Overall, 42% (n=330/780) were non-drinkers, 32% (n=251/780) were low-risk drinkers, and 26% (n=199/780) were high-risk drinkers. Compared to non-drinkers, low- and high-risk drinkers were significantly younger whereas a larger proportion of low-risk drinkers reported being African-American compared to non- or high-risk drinkers. High-risk drinkers reported significantly lower pain severity/interference compared to the other groups; high-risk drinkers were also less likely to be on disability compared to other groups. A multinomial logistic regression showed that patients reporting lower pain severity and less disability had greater odds of being classified a high-risk drinker. CONCLUSIONS: High-risk drinking appears common among medical cannabis patients. Future research should examine whether such use is concurrent or consecutive, and the relationship of such co-use patterns to consequences. Nevertheless, individuals treating patients reporting medical cannabis use for pain should consider alcohol consumption, with data needed regarding the efficacy of brief alcohol interventions among medical cannabis patients.

Prevalence and correlates of sleep-related problems in adults receiving medical cannabis for chronic pain.

PURPOSE: To examine the prevalence and correlates of sleep problems in a sample of medical cannabis patients. PROCEDURES: Adults ages 21 and older (N=801,M age=45.8) who were seeking medical cannabis certification (either for the first time or as a renewal) for chronic pain at medical cannabis clinics in southern Michigan completed baseline measures of cannabis use, sleep, pain, and other related constructs. FINDINGS: Over half of the sample (59%) met criteria for past 1-month sleep disturbance, defined as at least one sleep problem occurring on 15 or more nights in the past month. Most participants (86%) reported that sleep problems were due to their current pain. Approximately 80% of participants reported using cannabis in the past 6 months to improve sleep and, among these participants, cannabis was rated as helpful for improving sleep. Sleep-related cannabis side effects were rare (35%), but sleep-related cannabis withdrawal symptoms were relatively common (65%). Statistically significant correlates of past 1-month sleep disturbance included a) being female, b) being white, c) being on disability, d) not having a medical cannabis card, and e) frequency of using cannabis to help sleep. CONCLUSIONS: Sleep problems are highly prevalent and frequent in medical cannabis patients and are closely tied to pain. Sleep-related cannabis withdrawal symptoms are relatively common but their clinical relevance is unknown. The association between frequency of cannabis use to help sleep with higher odds of sleep problems will need to be clarified by longitudinal studies.

Prevalence and correlates of "Vaping" as a route of cannabis administration in medical cannabis patients.

PURPOSE: To examine the prevalence and correlates of vaporization (i.e., "vaping") as a route of cannabis administration in a sample of medical cannabis patients. PROCEDURES: Adults ages 21 and older (N=1485M age=45.1) who were seeking medical cannabis certification (either for the first time or as a renewal) at medical cannabis clinics in southern Michigan completed a screening assessment. Participants completed measures of route of cannabis administration, cannabis use, alcohol and other substance use. FINDINGS: An estimated 39% (n=511) of the sample reported past-month cannabis vaping, but vaping as the sole route of cannabis administration was rare. Specifically, only 30 participants (2.3% of the full sample and 5.9% of those who reported any vaping) indicated vaping as the sole route of cannabis administration. The majority (87.3%) of those who reported vaping also reported smoking (combustion) as a route of cannabis administration. Being younger than age 44, having more than a high school education, engaging in nonmedical stimulant use, being a returning medical cannabis patient, and greater frequency of cannabis use were associated with higher odds of vaping at the bivariate level and with all variables considered simultaneously. CONCLUSIONS: Vaping appears to be relatively common among medical cannabis patients, but is seldom used as the sole route of cannabis administration. RESULTS: highlight the importance of monitoring trends in vaping and other substance use behaviors in this population and underscore the need for longitudinal research into the motives, correlates, and consequences of cannabis vaping in medical cannabis patients.