The American Society of Addiction Medicine Clinical Practice Guideline Development Methodology.

ABSTRACT: The American Society of Addiction Medicine (ASAM) has published clinical practice guidelines (CPGs) since 2015. As ASAM's CPG work continues to develop, it maintains an organizational priority to establish rigorous standards for the trustworthy production of these important documents. In keeping with ASAM's mission to define and promote evidence-based best practices in addiction prevention, treatment, and recovery, ASAM has rigorously updated its CPG methodology to be in line with evolving international standards. The CPG Methodology and Oversight Subcommittee was formed to establish and publish a methodology for the development of ASAM CPGs and to develop an ASAM CPG strategic plan. This article provides a focused overview of the ASAM CPG methodology.

Description and Evaluation of a Pilot Advanced Pharmacy Practice Experience in Addiction Medicine.

Objective. To assess the impact of a pilot advanced pharmacy practice experience (APPE) on fourth-year (P4) Doctor of Pharmacy (PharmD) students' knowledge and confidence related to substance use disorder, harm reduction, and co-occurring psychiatric conditions.Methods. Beginning in 2020, a 62-item assessment was developed and administered to P4 students at the beginning and end of the six-week APPE. The assessment tested knowledge in 10 content areas related to substance use disorder, harm reduction, and co-occurring disorders. Students also ranked their confidence in providing care related to each content area. The post-assessment included a free-text (open-ended) item to provide feedback on the APPE experience. Descriptive statistics and paired t tests were used to analyze the data.Results. Complete pre- and post-assessments were obtained from all participating students (N=7). The mean cumulative knowledge score increased from 55.2% to 81.5%, and the mean cumulative confidence score improved from 34.2% to 81.8%. Free-text responses garnered positive feedback from students, who indicated that the APPE allowed them to immerse themselves in all stages of the recovery process, gain confidence in presentation skills with patients, and solidify their passion for addiction medicine.Conclusion. A novel APPE in addiction medicine addressed a current gap in pharmacy education, earned positive evaluations from student pharmacists, increased student knowledge and confidence related to substance use disorder, harm reduction, and co-occurring disorders, and supported the development of new interprofessional collaborations. United States colleges of pharmacy that do not yet offer APPEs in this clinical domain should consider this model.

Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial.

BACKGROUND: As pharmacological treatments are the primary option for opioid use disorder, neuromodulation has recently demonstrated efficacy in managing opioid withdrawal syndrome (OWS). This study investigated the safety and effectiveness of transcutaneous auricular neurostimulation (tAN) for managing OWS. METHODS: This prospective inpatient trial included a 30-minute randomized, sham-controlled, double-blind period followed by a 5-day open-label period. Adults with physical dependence on opioids were randomized to receive active or sham tAN following abrupt opioid discontinuation. The Clinical Opiate Withdrawal Scale (COWS) was used to determine withdrawal level, and participants were required to have a baseline COWS score ≥ 13 before enrollment. The double-blind period of the study occurred during the first 30-minutes to assess the acute effects of tAN therapy compared to a sham control. Group 1 received active tAN during both the 30-minute double-blind period and the 5-day open-label period. Group 2 received passive sham tAN (no stimulation) during the double-blind period, followed by active tAN during the 5-day open-label period. The primary outcome was change in COWS from baseline to 60-minutes of active tAN (pooled across groups, accounting for 30-minute delay). Secondary outcomes included difference in change in COWS scores between groups after 30-minutes of active or sham tAN, change in COWS scores after 120-minutes of active tAN, and change in COWS scores on Days 2-5. Non-opioid comfort medications were administered during the trial. RESULTS: Across all thirty-one participants, the mean (SD) COWS scores relative to baseline were reduced by 7.0 (4.7) points after 60-minutes of active tAN across both groups (p < 0.0001; Cohen's d = 2.0), demonstrating a significant and clinically meaningful reduction of 45.9%. After 30-minutes of active tAN (Group 1) or sham tAN (Group 2), the active tAN group demonstrated a significantly greater COWS score reduction than the sham tAN group (41.7% vs. 24.1%; p = 0.036). Participants across both groups achieved an average COWS reduction up to 74.7% on Days 2-5. CONCLUSION: Results demonstrate tAN is a safe and effective non-opioid approach for reducing symptoms of OWS. This study supported an FDA clearance. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov/ct2/show/NCT04075214 , Identifier: NCT04075214, Release Date: August 28, 2019.

Lofexidine for acute opioid withdrawal: A clinical case series.

INTRODUCTION: Maintaining abstinence through the opioid withdrawal period is a substantial barrier to treatment for patients with opioid use disorder. The alpha-2 agonist lofexidine has demonstrated efficacy and safety in clinical trials, but pragmatic studies describing its use in clinical practice are lacking. This case series describes the use of lofexidine for opioid withdrawal symptoms in an inpatient addiction treatment facility. METHODS: Seventeen patients receiving at least 1 dose of lofexidine during inpatient treatment for opioid withdrawal were included in this study. A retrospective chart review was conducted for clinical, subjective, and objective data. Adverse events, total daily dose, clinical opioid withdrawal scale (COWS) scores, vital signs, and reasons for early discontinuation of lofexidine are reported. RESULTS: Patients treated with lofexidine experienced mild withdrawal symptoms throughout treatment. Most patients (65%) experienced a decrease in their average daily COWS scores from intake to discharge. Two patients (12%) left treatment against medical advice, and 5 patients (29%) discontinued treatment prior to day 7 due to resolution of symptoms. Average daily blood pressure readings remained stable, and daily average heart rate decreased over time. DISCUSSION: Lofexidine can be successfully incorporated into a conventional withdrawal management protocol. The cost of lofexidine and its recent introduction to the market remain barriers to accessibility in the United States. Studies evaluating patient-reported outcomes as well as direct comparisons with other alpha-2 agonists are needed to inform optimal clinical use of lofexidine.

How Should Remote Clinical Monitoring Be Used to Treat Alcohol Use Disorders?: Initial Findings From an Expert Round Table Discussion.

Scientific evidence combined with new health insurance coverage now enable a chronic illness management approach to the treatment of alcohol use disorders (AUDs), including regular monitoring of blood alcohol content (BAC), as a useful indicator of disease control. Recent technical advances now permit many different types of remote, real-time monitoring of BAC. However, there is no body of research to empirically guide clinicians in how to maximize the clinical potential of remote BAC monitoring.As an initial step in guiding and supporting such research, the manufacturer of one remote BAC monitoring system sponsored a group of experienced clinicians and clinical researchers to discuss 8 issues that generally affect remote, clinical BAC monitoring of "adults in outpatient AUD treatment."The expert panel unanimously agreed that remote BAC monitoring for at least 12 months during and after the outpatient treatment of AUD was a clinically viable deterrent to relapse. There was also consensus that positive test results (ie, recent alcohol use) should lead to intensified care and monitoring. However, there was no agreement on specific types of clinical intensification after a positive test. The panel agreed that sharing positive and negative test results with members of the patient support group was helpful in reinforcing abstinence, yet they noted many practical issues regarding information sharing that remain concerning. Significant differences within the panel on several important clinical issues underline the need for more clinical and implementation research to produce empirically-supported guidelines for the use of remote BAC monitoring in AUD treatment.

Characteristics of Mexican and Mexican American adolescents in treatment for "cheese" heroin use.

Clinical and cultural characteristics of Hispanic adolescent heroin users are not well described. The current exploratory study was conducted to describe a sample of in-treatment Hispanic adolescents with opioid dependence, specifically, cheese heroin. Mexican and Mexican American adolescents with heroin dependence (N = 72) in three treatment programs were interviewed and completed self-report measures. Participants reported, on average, first using cheese heroin at age 13.5 years and daily use at age 14.2 years. The majority (74%) reported a previous overdose. Adolescents being raised by caregivers other than both biological parents, who used drugs with relatives, and whose immediate family members have documentation to be in the United States fared worse on several indicators of drug use severity and other risky behaviors. The self-reported brief time period from first use to daily use strongly suggests the need for early prevention efforts. Additional research is needed to add to these preliminary results and inform prevention efforts.

Cheese: an old drug in a new wrapper.

BACKGROUND: An unexpected outbreak of "cheese" heroin, which contained diphenhydramine and usually acetaminophen, began in Dallas around 2004. Onset occurred among youths living in neighborhoods populated by first-generation Hispanic immigrants. Little was known about the problem or the social strengths and deficits of these youth, who were primarily inhalers ("snorters") but at risk of transitioning to injection. METHODS: Multiple data sources were used, including surveys, data from emergency departments, law enforcement, treatment programs, and coroner, and interviews with users and key informants. RESULTS: Among heroin users under age 20, overdose deaths peaked in 2006, the school survey responses to using "cheese" heroin peaked in 2007, and treatment admissions peaked in 2008. Hispanic youth entering treatment were less likely to be injectors and report fewer problems than their Anglo counterparts and they were more likely to live with their families and to be supported by them. Sixty percent of the Hispanic youth had been in treatment previously and only 53% completed treatment. Cocaine and/or benzodiazepines were involved in 32% of the adolescent heroin deaths. CONCLUSIONS: The timely use of multiple data sources enabled this outbreak to be quickly identified and monitored, and the Cheese Heroin Task Force used the collected data to help respond to the problem, although retention in treatment and readmissions remained problematic. Cultural problems including immigration status, language, and misunderstandings about the nature of treatment were barriers to successful treatment outcomes. Completion of treatment as an inhaler is critical to reducing the likelihood of transitioning to injection.

Perceived barriers to hepatitis C therapy for patients receiving opioid agonist treatment.

OBJECTIVES: To explore attitudes toward hepatitis C antiviral therapy in a real-world setting, we asked patients in opioid agonist treatment who were offered antiviral therapy about perceived barriers to initiating therapy. METHODS: We recruited patients in opioid agonist treatment who had previously been offered cost-free hepatitis C antiviral therapy in a clinical trial. We collected demographic and open-ended interview data. The semistructured interview guide included questions about attitudes toward hepatitis C therapy and barriers to initiating treatment. Each interview was audio recorded and transcribed verbatim. We used the qualitative editing method to analyze the interview transcripts. RESULTS: We enrolled 19 patients who had been approached to initiate hepatitis C therapy in a clinical trial. All participants were low-income men, with one third self-identifying as racial minorities. When asked about possible barriers to treatment, multiple problems emerged, including the fear of treatment side effects, difficulties with health care providers, limited access to medical care and health information, and misperceptions about antiviral therapy. CONCLUSIONS: Despite intense educational efforts, concerns over antiviral therapy, relations with providers, and access to the health care system remain critical barriers. These factors should be addressed to improve antiviral therapy rates for patients receiving opioid agonist treatment.

Combined effects of alcohol and hepatitis C: a secondary analysis of alcohol use biomarkers and high-risk behaviors from two medication trials for alcohol dependence.

OBJECTIVES: The goal of this secondary analysis was to examine the combined effects of HCV infection and recent alcohol use on baseline biologic markers of alcohol consumption in two outpatient medication trials for alcohol dependence. In addition, the relationship between Hepatitis C virus (HCV) infection and behavioral risk factors for HCV infection in these clinical populations were examined. METHODS: Data (n=345) from two randomized, placebo-controlled trials of naltrexone and psychosocial treatment for alcohol dependence (Study I, n=212) and comorbid alcohol and cocaine dependence (Study II, n=133) were used to examine baseline measures of HCV risk behaviors (injection drug use, needle sharing), and biomarkers of alcohol use (AST, ALT, GGT and CDT) were compared by HCV serostatus first within each study and then across studies. RESULTS: Although groups had differing sociodemographic profiles (as indicated by race, marital status, level of education) subjects in Study I exhibited no statistically significant differences from the Study II cohort in HCV prevalence (12.7 vs. 20.0%, p=0.07), lifetime history of injection drug use (13.8 vs. 22.0%, p=0.74), lifetime history of needle sharing (9.1 vs. 18.0%, p=0.62). As such, the data from both studies were analyzed together. Regardless of drinking status, HCV infection was significantly associated with an upward shift in the baseline level of ALT, AST, and GGT (p<0.006 for all measures) and a downward shift in baseline CDT (p=0.002). When using standard laboratory cutoff values to determine clinically significant elevations, HCV seropositivity was significantly associated with elevations in ALT, AST, GGT (p<0.001), and with decreases in CDT (p=.002). CONCLUSIONS: These data emphasize the importance of evaluating HCV infection and HCV risk behaviors at intake in medication trials for alcohol dependence and also raise questions regarding the use of cutoff scores for ALT, AST, GGT and CDT levels as biologic markers of alcohol use in subjects when HCV status is unknown.

Atomoxetine for treatment of marijuana dependence: a report on the efficacy and high incidence of gastrointestinal adverse events in a pilot study.

Marijuana users consistently demonstrate impairments in attention, executive function and response inhibition, which resemble deficits seen in attention deficit hyperactivity disorder (ADHD). We hypothesized that targeting the cognitive deficits associated with chronic marijuana use through ADHD medications may help identify a therapeutic agent for marijuana dependence. Thirteen subjects participated in an 11-week open label study to determine the feasibility, safety and tolerability of atomoxetine for individuals seeking treatment for marijuana dependence. The Time-Line Follow-Back measured marijuana use 90 days prior to study entry (p-TLFB) and weekly during the study (s-TLFB) along with weekly qualitative urine drug screen (UDS). For the eight subjects who completed the trial, the TLFB data showed a trend toward reduction in use with an increase in percent days abstinent (p=0.06). Analysis of weekly UDSs did not confirm the TLFB trend with 94% of all possible UDSs positive for THC through out the study. Marijuana dependent subjects taking atomoxetine experienced an inordinate number of gastrointestinal (GI) adverse events. Overall, 10 of 13 subjects (77%) experienced a mild to moderate GI adverse event defined as nausea, vomiting, dyspepsia, and loose stools. Atomoxetine is of limited utility in the treatment of cannabis dependence and is associated with clinically significant GI adverse events.