Feasibility Pilot Study of an Opioid Helpline for Individuals at High Risk for Opioid Use Disorder.

BACKGROUND: Evidence suggests that educational interventions delivered by healthcare providers can be effective in altering patients' attitudes toward pain management and in referral to addiction treatment when appropriate. Time constraints during visits limit the delivery of such important interventions. OBJECTIVE: This study aims to explore the feasibility and perceived value of an opioid helpline that provides resources to individuals suffering from or at risk for opioid use disorder. METHODS: We developed a helpline with a toll-free number "1-877 OPIOIDS (6437)" established through the University of Virginia, which runs Monday through Friday from 8:30 am to 5 pm and is answered by a live answering service after hours. The helpline offered a range of resources including opioid pain medication education, signs of overdose or withdrawal, addiction treatment options, and connection to treatment services. The helpline was supported by outreach efforts to surrounding counties in Virginia. Questionnaires on perceived usefulness were sent to callers and providers who used or offered the helpline in their clinics. Survey data were analyzed to identify trends. RESULTS: Thirty-one consented individuals of 166 contacts were included in the study. Although participants were referred to the helpline through a variety of sources, most were referred by a physician (38.7%). Most participants rated the helpline's helpfulness with the highest satisfaction score (81.5%). Most individuals seeking addiction treatment found the helpline to be useful, whereas those referred by their respective physician to gain more information about their opioid use and prevent escalation to addiction felt it was an unnecessary step. CONCLUSIONS: Our pilot study demonstrated that a helpline could be an additional tool to combat the opioid crisis. Individual callers rated the intervention favorably. Our study shows that the most substantial area of satisfaction for our participants is being able to reach a live person when in need.

Topiramate decreases the salience of motivationally relevant visual cues among smokers with alcohol use disorder.

BACKGROUND: There is preliminary evidence that the anticonvulsant topiramate increases the likelihood of both smoking and alcohol abstinence among smokers with alcohol use disorder (AUD), but its therapeutic mechanism has not been determined. We used event-related potentials (ERPs) to evaluate topiramate's effect on the salience of drug-related, emotional, and neutral pictorial cues to identify whether one of its potential therapeutic mechanisms involves reduction of the salience of motivationally relevant cues. METHODS: Participants enrolled in a multisite clinical trial treating smokers with AUD were randomly assigned to receive placebo, low-dose topiramate (up to 125 mg/day), or high-dose topiramate (up to 250 mg/day), along with brief behavioral compliance enhancement treatment. A subsample (n = 101) completed ERP assessments at baseline (1 week pre-medication) and week 5 (5 weeks on medication; 1 week pre-quit). We assessed the salience of pleasant, unpleasant, cigarette-related, alcohol-related, and neutral pictorial cues using the late positive potential (LPP) ERP component and measured self-reported substance use, reinforcement, craving, and withdrawal. RESULTS: Five weeks of high-dose topiramate treatment decreased LPP amplitudes in response to both emotional (pleasant and unpleasant) and drug-related cues (alcohol and cigarette), but not to neutral cues. However, results showed that the LPPs were not significant mediators of the relationship between topiramate dose and post-quit measures of substance use, reinforcement, craving, or withdrawal. CONCLUSIONS: These findings suggest that high-dose topiramate (up to 250 mg/day) decreases the motivational salience of both drug-related and emotional cues among smokers with AUD. However, the nonsignificant mediation analyses preclude any firm conclusions about whether this effect represents one of topiramate's therapeutic mechanisms of action.

Behavioral Economic Assessment of Alcohol and Cigarette Demand in Smokers With Alcohol Use Disorder.

Background and Objectives: Behavioral economic purchase tasks are widely used to assess drug demand in substance use disorder research. Comorbid alcohol use is common among cigarette smokers and associated with greater difficulty in quitting smoking. However, demand for alcohol and cigarettes in this population has not been fully characterized. The present study addressed this gap by examining alcohol and cigarette demand among treatment-seeking smokers with alcohol use disorder (AUD). Methods: Alcohol and cigarette demand was assessed among 99 smokers with AUD. We conducted Principal Component Analysis (PCA) and correlational analyses on the demand indices. Results: Participants showed higher demand for alcohol than for cigarettes, as evidenced lower elasticity (resistance to increasing price) and higher Omax (maximum response output for drug). PCA revealed a two-factor structure (Persistence and Amplitude) for both alcohol and cigarette demand indices. Cigarette-related demand indices were positively correlated with nicotine dependence, but alcohol-related demand indices were not associated with alcohol dependence, suggesting dissociation between alcohol demand and use behaviors. Discussion and Conclusions: Our results suggest that smokers with AUD were more resistant to price elevations in relation to reducing alcohol consumption as compared to cigarette consumption, suggesting preferential demand for alcohol over cigarettes. However, it is unclear how acute substance exposure/withdrawal impacts the demand indices. Scientific Significance: Potentially differential alcohol and cigarette demands among smokers with AUD should be considered in the concurrent treatment of smoking and alcohol.

A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study.

BACKGROUND: Opioid use disorder (OUD) is a public health crisis with more than 2 million people living with OUD in the United States. Medication-assisted treatment (MAT) is an evidence-based approach for the treatment of OUD that relies on a combination of behavioral therapy and medication. Less than half of those living with OUD are accessing this treatment. Mobile technology can enhance the treatment of chronic diseases in readily accessible and cost-effective ways through self-monitoring and support. OBJECTIVE: The aim of this study is to describe the adaptation of a mobile platform for patients undergoing treatment for OUD and preliminary pilot testing results. METHODS: Our study was conducted with patient and provider participants at the University of Virginia MAT clinic and was approved by the institutional review board. The formative phase included semistructured interviews to understand the needs of patients with OUD, providers' perspectives, and opportunities for MAT support via a mobile app. A second round of formative interviews used mock-ups of app features to collect feedback on feature function and desirability. Formative participants' input from 16 interviews then informed the development of a functional smartphone app. Patient participants (n=25) and provider participants (n=3) were enrolled in a 6-month pilot study of the completed platform. Patient app use and usability interviews, including a system usability score and open-ended questions, were completed 1 month into the pilot study. Open-ended responses were analyzed for prevalent themes. RESULTS: Formative interviews resulted in the development of a mobile app, named HOPE, which includes both evidence-based and participant-suggested features. The features included daily prompts for monitoring mood, stress, treatment adherence, and substance use; patient tracking of goals, reminders, and triggering or encouraging experiences; informational resources; an anonymous community board to share support with other patients; and secure messaging for communication between patients and providers. All patient participants engaged with at least one app feature during their first month of pilot study participation, and the daily self-monitoring prompts were the most used. Patients and providers reported high levels of system usability (mean 86.9, SD 10.2 and mean 83.3, SD 12.8, respectively). Qualitative analysis of open-ended usability questions highlighted the value of self-monitoring, access to support through the app, and perceived improvement in connection to care and communication for both patient and provider participants. CONCLUSIONS: The use of the HOPE program by pilot participants, high usability scoring, and positive perceptions from 1-month interviews indicate successful program development. By engaging with end users and eliciting feedback throughout the development process, we were able to create an app and a web portal that was highly usable and acceptable to study participants. Further work is needed to understand the program's effect on clinical outcomes, patient linkage, and engagement in care.

Gabapentin Enacarbil Extended-Release for Alcohol Use Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multisite Trial Assessing Efficacy and Safety.

BACKGROUND: Several single-site alcohol treatment clinical trials have demonstrated efficacy for immediate-release (IR) gabapentin in reducing drinking outcomes among individuals with alcohol dependence. The purpose of this study was to conduct a large, multisite clinical trial of gabapentin enacarbil extended-release (GE-XR) (HORIZANT® ), a gabapentin prodrug formulation, to determine its safety and efficacy in treating alcohol use disorder (AUD). METHODS: Men and women (n = 346) who met DSM-5 criteria for at least moderate AUD were recruited across 10 U.S. clinical sites. Participants received double-blind GE-XR (600 mg twice a day) or placebo and a computerized behavioral intervention (Take Control) for 6 months. Efficacy analyses were prespecified for the last 4 weeks of the treatment period. RESULTS: The GE-XR and placebo groups did not differ significantly on the primary outcome measure, percentage of subjects with no heavy drinking days (28.3 vs. 21.5, respectively, p = 0.157). Similarly, no clinical benefit was found for other drinking measures (percent subjects abstinent, percent days abstinent, percent heavy drinking days, drinks per week, drinks per drinking day), alcohol craving, alcohol-related consequences, sleep problems, smoking, and depression/anxiety symptoms. Common side-effects were fatigue, dizziness, and somnolence. A population pharmacokinetics analysis revealed that patients had lower gabapentin exposure levels compared with those in other studies using a similar dose but for other indications. CONCLUSIONS: Overall, GE-XR at 600 mg twice a day did not reduce alcohol consumption or craving in individuals with AUD. It is possible that, unlike the IR formulation of gabapentin, which showed efficacy in smaller Phase 2 trials at a higher dose, GE-XR is not effective in treating AUD, at least not at doses approved by the U.S. Food and Drug Administration for treating other medical conditions.