Faculty Bibliography

Aim: Naltrexone is first-line pharmacotherapy for alcohol use disorders (AUD). Oral naltrexone (ONTX) is under-prescribed in primary care and possibly limited by poor adherence. Monthly injectable extended-release naltrexone (XR-NTX) may improve adherence and good clinical outcomes.
Method(s): This is a randomized, open-label, comparative effectiveness trial of 24 weeks of XR-NTX vs. O-NTX as AUD treatment in primary care at a public hospital in New York City. Adults (>18 yo) with AUD randomized to XR-NTX (380 mg/month) vs. O-NTX (50 mg/day) with Medical Management. Self-reported daily drinking recall informed the primary outcome, a Good Clinical Outcome (GCO) across weeks 5-24, defined as abstinence or moderate drinking and 0-2 days of heavy drinking per month. Data & Results: N = 237 adults randomized (n = 117 XR-NTX; n = 120 O-NTX); mean age 48.5 (SD 10.6); 71%male; 54%AA, 21% Hispanic; 41%employed. At baseline mean drinks/day were 9.6 (SD 11.6); 29% abstinent days; 61%heavy drinking days; mean Obsessive Compulsive Drinking Scale (OCDS) scores were 17.6 (SD 7.1) and mean AUDIT scores were 24.2 (SD 8.0). 64%of monthly XR-NTX injections were received and 67%ofmonthly O-NTX refills were provided. The primary GCO across weeks 5-24 was reported by 29%XR-NTX and 23%O-NTX (p = 0.29). Mean months with a GCO was 2.9 XR-NTX, 2.5 O-NTX (p = 0.21). Rates of%days abstinent (70%XRNTX vs. 71%O-NTX; p = 0.77) and %heavy drinking days (20%XR-NTX vs. 16%O-NTX; p = 0.28) were similar weeks 1-24. Mean blood pressure decreased from 127/86 mmHg at baseline to 124/83 mmHg at week 25; there was no change in mean weight (180 lb) pre/post, and there were no differences in BP or weight changes by arm. Declines in OCDS scores (17.6 to 7.6) were similar by arm.
Conclusion(s): Initiation and retention on both forms of naltrexone was robust. Overall, participants reported improved longitudinal drinking outcomes. There was insufficient evidence of any differences in primary and secondary self-reported drinking outcomes between monthly XR-NTX and daily ONTX. Additional analysis will examine CDT and LFT levels during treatment, and interactions with OPMR1 genotype status

BACKGROUND:Extended-release naltrexone (XR-NTX, Vivitrol®) and daily oral naltrexone tablets (O-NTX) are FDA-approved mu opioid receptor antagonist medications for alcohol dependence treatment. Despite the efficacy of O-NTX, non-adherence and poor treatment retention have limited its adoption into primary care. XR-NTX is a once-a-month injectable formulation that offers a potentially more effective treatment option in reducing alcohol consumption and heavy drinking episodes among persons with alcohol use disorders. METHODS:This pragmatic, open-label, randomized controlled trial examines the effectiveness of XR-NTX vs. O-NTX in producing a Good Clinical Outcome, defined as abstinence or moderate drinking (<2 drinks/day, men; <1 drink/day, women; and < 2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management treatment for alcohol dependence. Secondary aims will estimate the cost effectiveness of XR-NTX vs. O-NTX, in conjunction with primary-care based Medical Management for both groups, and patient-level characteristics associated with effectiveness in both arms. Alcohol dependent persons are recruited from the community into treatment in a New York City public hospital primary care setting (Bellevue Hospital Center) for 24 weeks of either XR-NTX (n = 117) or O-NTX (n = 120). RESULTS:We describe the rationale, specific aims, design, and recruitment results to date. Alternative design considerations and secondary aims and outcomes are reported. CONCLUSIONS:XR-NTX treatment in a primary care setting is potentially more efficacious, feasible, and cost-effective than oral naltrexone when treating community-dwelling persons with alcohol use disorders. This study will estimate XR-NTX's treatment and cost effectiveness relative to oral naltrexone.

BACKGROUND:Research demonstrates strong associations between adverse childhood experiences (ACEs) and non-medical prescription opioid use (NMPO), but pathways are not understood, hindering prevention and treatment responses. METHODS:We assessed hypothesized mediators of the association between ACEs and NMPO in a nationally-representative U.S. SAMPLE/METHODS:National Longitudinal Study of Adolescent to Adult Health data (N = 12,288) yielded an ordinal exposure comprising nine ACEs (neglect; emotional, physical, sexual abuse; parental incarceration and binge drinking; witnessed, threatened with, experienced violence) and a binary lifetime NMPO outcome. Nine potential mediators measured in adolescence and/or adulthood included depression, anxiety, suicidality, delinquency, impulsivity, and risk-taking. We estimated adjusted odds ratios (AOR) and 95% confidence intervals (CI) for sex-stratified associations of: ACEs and mediators; mediators and NMPO; and ACEs and NMPO adjusting for mediators individually and simultaneously. RESULTS:All associations of ACEs and mediators were statistically significant and similar by sex. All mediators had statistically significant associations with NMPO (except one depression measurement for each sex). Delinquency was strongly associated with ACEs and NMPO and was the strongest individual mediator. Every ACE increase was associated with increased NMPO odds of 32% for males and 27% for females. Adjusting for all mediators, odds of NMPO were attenuated partially for males [AOR = 1.18 (95% CI:1.07, 1.31)] and somewhat more for females [AOR = 1.11 (95% CI:1.00, 1.25)]. CONCLUSIONS:Internalizing and externalizing factors partially explained the pathway from ACEs to NMPO. Substance abuse may be more difficult to treat with co-occurring psychopathologies and maladaptive behaviors, highlighting the need to address trauma early in life.

Background/UNASSIGNED:Smoking remains a major public health burden among persons with opioid and/or alcohol use disorder. Methods/UNASSIGNED:A 49-item semi-structured survey was conducted among urban, inpatient detoxification program patients eliciting demographic and clinical characteristics, smoking profile, technology use patterns, and preferences for adopting technology-based smoking cessation interventions. Multivariate logistic regression models further evaluated the association between participant demographic and clinical characteristics and technology preferences. Results/UNASSIGNED:Participants were mostly male (91%), and admitted for detoxification for alcohol (47%), heroin (31%), or both alcohol and heroin (22%). Past 30-day smoking was reported by 78% of the sample. Mobile phone ownership was common (89%); with an average past-year turnover of 3 mobile phones and 3 phone numbers. Computer ownership was low (28%) and one third reported daily internet use (34%). Telephone (41%) and text message-based interventions (40%) were the most popular platforms to facilitate smoking cessation. Conclusions/UNASSIGNED:Despite concurrent AUD-OUD, most respondents had attempted to quit smoking in the last year and preferred telephone- and text message-based interventions to facilitate smoking cessation. High turnover of mobile phones, phone numbers, and limited access to computers pose barriers to dissemination of technology-based smoking cessation interventions in this vulnerable population.

CONTEXT/BACKGROUND:Palliative care (PC) consultations result in improved patient understanding of prognosis and better quality of life, yet the content and processes of prognosis communication during PC consultations remain unknown. OBJECTIVES/OBJECTIVE:To describe prognosis communication during PC consultation with seriously ill hospitalized patients. METHODS:We audio recorded 71 sequential inpatient PC consultations (initial visit) with seriously ill patients and their families who were referred for "goals of care" clarification or help with "end-of-life decision making." Conversations were coded using reliable methods and we then linked conversation codes to clinical record and clinician interview data. RESULTS:Ninety-three percent of consultations contained prognosis communication. Participants communicated prognoses regarding quality of life more frequently than survival; focused prognosis estimates on the unique patient more frequently than on a general population; and framed prognosis using pessimistic cues more frequently than optimistic ones. Prognoses were more commonly spoken by PC clinicians than by patients/families. The following two factors demonstrated an association with the rate of prognostic communication and with the pessimistic framing of that information: whether the patient, family, or both participated in the conversation, and shorter expected survival (as estimated by the attending physician). CONCLUSION/CONCLUSIONS:Prognoses are routinely communicated in PC consultations with hospitalized patients and their families. The rate and characteristics of prognosis communication differ based on the length of time the patient is expected to live.