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Perceptions of extended-release naltrexone, methadone, and buprenorphine treatments following release from jail

Velasquez, Melissa; Flannery, Mara; Badolato, Ryan; Vittitow, Alexandria; McDonald, Ryan D; Tofighi, Babak; Garment, Ann R; Giftos, Jonathan; Lee, Joshua D
BACKGROUND:Few studies have documented patient attitudes and experiences with extended-release naltrexone (XR-NTX) opioid relapse prevention in criminal justice settings. This study assessed barriers and facilitators of jail-to-community reentry among adults with opioid use disorder (OUD) treated with XR-NTX, buprenorphine, methadone, and no medications. METHODS:This qualitative study conducted individual interviews with a purposeful and convenience sample of adults with OUD who were recently released from NYC jails. XR-NTX, no medication, and methadone participants were concurrently enrolled in a large randomized controlled trial evaluating XR-NTX vs. a no medication Enhanced Treatment As Usual (ETAU) condition, or enrolled in a non-randomized quasi-experimental methadone maintenance cohort. Buprenorphine participants were referred from NYC jails to a public hospital office-based buprenorphine program and not enrolled in the parent trial. Interviews were audio recorded, transcribed, independently coded by two researchers, and analyzed per a grounded theory approach adapted to the Social Cognitive Theory framework. The research team reviewed transcripts and coding to reach consensus on emergent themes. RESULTS:N = 33 adults with OUD (28 male, 5 female) completed a single individual interview. Purposeful sampling recruited persons leaving jail on XR-NTX (n = 11), no active medication treatment (n = 9), methadone (n = 9), and buprenorphine (n = 4). Emergent themes were: (1) general satisfaction with XR-NTX's long-acting antagonist effects and control of cravings; (2) "testing" XR-NTX's blockade with heroin upon reentry was common; (3) early discontinuation of XR-NTX treatment was most common among persons with high self-efficacy and/or heavy exposure to drug use environments and peers; (4) similar satisfaction regarding effects of methadone and buprenorphine maintenance among retained-in-treatment individuals, alongside general dissatisfaction with daily observed dosing requirements and misinformation and stigmas regarding methadone adverse effects; (5) unstable housing, economic insecurity, and exposure to actively using peers were attributed to early termination of treatment and relapse; (6) individual motivation and willpower as central to long-term opioid abstinence and reentry success. CONCLUSIONS:In the context of more familiar agonist maintenance treatments, XR-NTX relapse prevention during jail-to-community reentry was viewed as a helpful and unique intervention though with important limitations. Commonly described barriers to treatment retention and heroin abstinence included homelessness, economic insecurity, and drug-using peers. Trial registration ClinicalTrials.gov, NCT01999946 (XOR), Registered 03 December 2013, https://clinicaltrials.gov/ct2/show/NCT01999946 .
PMID: 31570100
ISSN: 1940-0640
CID: 4116102

Patient Barriers and Facilitators to Medications for Opioid Use Disorder in Primary Care

Tofighi, Babak; Williams, Arthur Robin; Chemi, Chemi; Sindhu, Selena; Dickson, Vicky; Lee, Joshua D
Introduction: This study explored factors influencing patient access to medications for opioid use disorder (OUD), particularly for individuals eligible but historically suboptimal follow-up with in-house referrals to office-based opioid treatment (OBOT). Objectives: In-depth qualitative interviews among a mostly underserved sample of adults with OUD elicited: 1) knowledge and experiences across the OUD treatment cascade; and 2) more nuanced elements of patient-centered care, including shared decision making with providers, experiences in OBOT versus specialty addiction treatment, transitioning from methadone to buprenorphine or extended-release naltrexone (XR-NTX), and voluntary discontinuation of medications for OUD. Methods: We conducted semi-structured qualitative interviews between January and February of 2018 among adult inpatient detoxification program patients with OUD (n = 23). Preliminary analysis of interviews yielded key themes and ideas that were coded from a grounded theory approach. Results: Willingness to engage with OBOT was influenced by a complex array of practical considerations, including access to patient-centered care in OBOT settings, positive experiences with illicitly obtained buprenorphine, and differential experiences pertaining to OBOT versus specialty addiction treatment. Responses were generally favorable towards OBOT with buprenorphine, yet knowledge regarding extended-release naltrexone was limited. Respondents were often frustrated by clinicians when requesting to transition from methadone to buprenorphine or XR-NTX. Lastly, participants elucidated limited access to OBOT programs in underserved neighborhoods and suburban settings. Conclusion: Limited access to patient-centered care in OBOT with buprenorphine and extended-release naltrexone may exacerbate challenges to retention and/or reengagement with OUD care.
PMID: 31429351
ISSN: 1532-2491
CID: 4046732

Technology preferences to enhance HIV and HCV care among patients with substance use disorders

Tofighi, Babak; Hein, Paul; Carvalho, Alexandre M S; Lee, Joshua D; Leonard, Noelle R
We examined technology use patterns (e.g., mobile phone and computer ownership, text messaging, internet access) and preferences for adopting health information technologies to optimize office-based treatment for substance use disorders, HIV, and Hepatitis C virus (HCV) infection. Surveys were administered to patients enrolled in inpatient detoxification program in a publicly-funded tertiary referral center. Most reported mobile phone ownership (86%) and described high rates of mobile phone (3.3) and phone number (2.6) turnover in the preceding year. Internet access was reported on a daily (52%) or weekly basis (22%). Most participants were amenable to receiving text message-based informational content (i.e., medications, support groups, treatment programs) pertaining to substance use disorders (79%), HIV (50%), and HCV care (58%). Respondents reporting less than high school education and past year incarcerated elicited higher favorability in adopting smartphone apps to facilitate peer sharing of HIV-HCV related content. Results suggest high favorability for adopting health information technologies to enhance office-based treatment for substance use disorders, HIV, and HCV, particularly among vulnerable patient sub-groups.
PMID: 31380732
ISSN: 1545-0848
CID: 4032782

Technology Use Patterns Among Patients Enrolled in Inpatient Detoxification Treatment

Tofighi, Babak; Leonard, Noelle; Greco, Peter; Hadavand, Aboozar; Acosta, Michelle C; Lee, Joshua D
BACKGROUND:Technology-based interventions offer a practical, low-cost, and scalable approach to optimize the treatment of substance use disorders (SUDs) and related comorbidities (HIV, hepatitis C infection). This study assessed technology use patterns (mobile phones, desktop computers, internet, social media) among adults enrolled in inpatient detoxification treatment. METHODS:A 49-item, quantitative and qualitative semi-structured survey assessed for demographic characteristics, technology use patterns (ie, mobile phone, text messaging [TM], smart phone applications, desktop computer, internet, and social media use), privacy concerns, and barriers to technology use. We used multivariate logistic regression models to assess the association between respondent demographic and clinical characteristics and their routine use of technologies. RESULTS:Two hundred and six participants completed the survey. Nearly all participants reported mobile phone ownership (86%). Popular mobile phone features included TM (96%), web-browsers (81%), and accessing social media (61%). There was high mobile phone (3.3 ± 2.98) and phone number (2.6 ± 2.36) turnover in the preceding 12 months. Nearly half described daily or weekly access to desktop computers (48%) and most reported internet access (67%). Increased smartphone ownership was associated with higher education status (P = 0.022) and homeless respondents were less likely to report mobile phone ownership (P = 0.010) compared to participants with any housing status (ie, own apartment, residing with friends, family, or in a halfway house). Internet search engines were used by some participants (39.4%, 71/180) to locate 12 step support group meetings (37%), inpatient detoxification programs (35%), short- or long-term rehabilitation programs (32%), and outpatient treatment programs (4%). CONCLUSIONS:Technology use patterns among this hard-to-reach sample of inpatient detoxification respondents suggest high rates of mobile phone ownership, TM use, and moderate use of technology to facilitate linkage to addiction treatment services.
PMID: 30589653
ISSN: 1935-3227
CID: 3563142

Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care [Meeting Abstract]

Malone, M; Vittitow, A; McDonald, R D; Tofighi, B; Garment, A; Schatz, D; Laska, E; Goldfeld, K; Rotrosen, J; Lee, J D
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
EMBASE:628239824
ISSN: 1530-0277
CID: 4024702

Smartphone Apps Targeting Alcohol and Illicit Substance Use: Systematic Search in in Commercial App Stores and Critical Content Analysis

Tofighi, Babak; Chemi, Chemi; Ruiz-Valcarcel, Jose; Hein, Paul; Hu, Lu
BACKGROUND:Smartphone apps promise to enhance the reach of evidence-based interventions (cognitive behavior therapy, contingency management and therapeutic education system) for populations with substance use disorders, with minimal disruption to health systems. However, further studies are needed to systematically evaluate smartphone apps targeting alcohol and illicit substances. OBJECTIVE:The aim of this study was to evaluate the functionality, aesthetics, and quality of information of free or low-cost apps claiming to target alcohol, benzodiazepine, cocaine, crack/cocaine, crystal methamphetamine, and heroin use using the validated Mobile App Rating Scale (MARS) and critical content analysis. METHODS:A systematic search of iTunes and Google Play app stores for free or low-cost apps facilitating recovery was conducted in March 2018 and yielded 904 apps using the keywords described in previous studies (eg, recovery, sobriety, sober, alcohol, and heroin). An interdisciplinary team of clinicians, behavioral informatics, and public health reviewers trained in substance use disorders conducted a descriptive analysis of 74 apps categorized as reducing use. In addition to the MARS scale, a descriptive analysis of relevant apps was conducted by the study team to assess for quality indicators emphasized by expert guidelines and review articles. RESULTS:Most apps (n=74) claimed to reduce use or promote abstinence and yielded an overall low median MARS score of 2.82 (0.55) and a wide range of scores (1.64, 4.20). Ratings were also low for engagement (2.75 (0.72)), functionality (3.64 (0.78)), aesthetics (3.03 (0.87)), information (2.82 (0.62)), and satisfaction (1.76 (0.67)) subdomains. Innovative design and content features elicited in the review included initial assessments of substance use following app download, tracking substance use, and related consequences (eg, cost or calorie intake), remote and proximate peer support per geospatial positioning, and allowing users and family members of individuals with substance use disorders to locate 12-step meetings, treatment programs, and mental health services. Few apps integrated evidence-based psychotherapeutic (eg, cognitive behavioral therapy [CBT] or motivational interviewing) and pharmacologic interventions (eg, naloxone or buprenorphine). CONCLUSIONS:Few commercially available apps yielded in our search integrated evidence-based interventions (eg, extended-release naltrexone, buprenorphine, naloxone, Self-Management and Recovery Training recovery, or CBT), and a concerning number of apps promoted harmful drinking and illicit substance use.
PMID: 31008713
ISSN: 2291-5222
CID: 3821302

Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON)

Malone, Mia; McDonald, Ryan; Vittitow, Alexandria; Chen, Jenny; Obi, Rita; Schatz, Dan; Tofighi, Babak; Garment, Annie; Goldfeld, Keith; Gold, Heather; Laska, Eugene; Rotrosen, John; Lee, Joshua D
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.
PMID: 30986535
ISSN: 1559-2030
CID: 3810362

Use of online opioid overdose prevention training for first-year medical students: A comparative analysis of online versus in-person training

Berland, Noah; Lugassy, Daniel; Fox, Aaron; Goldfeld, Keith; Oh, So-Young; Tofighi, Babak; Hanley, Kathleen
PURPOSE/OBJECTIVE:In response to the opioid epidemic and efforts to expand substance use education in medical school, the authors introduced opioid overdose prevention training (OOPT) with naloxone for all first-year medical students (MS1s) as an adjunct to required basic life support training (BLST). The authors previously demonstrated improved knowledge and preparedness following in-person OOPT with BLST; however, it remains unclear whether online-administered OOPT would produce comparable results. In this study, the authors perform a retrospective comparison of online-administered OOPT with in-person-administered OOPT. OBJECTIVES/OBJECTIVE:To compare the educational outcomes: knowledge, preparedness, and attitudes, for online versus in-person OOPT. METHODS:In-person OOPT was administered in 2014 and 2015 during BLST, whereas online OOPT was administered in 2016 during BLST pre-work. MS1s completed pre- and post-training tests covering 3 measures: knowledge (11-point scale), attitudes (66-point scale), and preparedness (60-point scale) to respond to an opioid overdose. Online scores from 2016 and in-person scores from 2015 were compared across all 3 measures using analysis of covariance (ANCOVA) methods. RESULTS:After controlling for pre-test scores, there were statistical, but no meaningful, differences across all measures for in-person- and online-administered training. The estimated differences were knowledge: -0.05 (0.5%) points (95% confidence interval [CI]: -0.47, 0.36); attitudes: 0.65 (1.0%) points (95% CI: -0.22, 1.51); and preparedness: 2.16 (3.6%) points (95% CI: 1.04, 3.28). CONCLUSIONS:The educational outcomes of online-administered OOPT compared with in-person-administered OOPT were not meaningfully different. These results support the use of online-administered OOPT. As our study was retrospective, based on data collected over multiple years, further investigation is needed in a randomized controlled setting, to better understand the educational differences of in-person and online training. Further expanding OOPT to populations beyond medical students would further improve generalizability.
PMID: 30767715
ISSN: 1547-0164
CID: 3656442

Testing hair for fentanyl exposure: a method to inform harm reduction behavior among individuals who use heroin

Palamar, Joseph J; Salomone, Alberto; Bigiarini, Rachele; Vincenti, Marco; Acosta, Patricia; Tofighi, Babak
BACKGROUND:Deaths from fentanyl exposure continue to increase in the US. Fentanyl test strips are now available to test urine for presence of fentanyl, but additional testing methods are needed to determine past exposure and to determine exposure to specific analogs. OBJECTIVES/OBJECTIVE:To investigate exposure to such analogs through hair testing. METHODS:Forty individuals in inpatient detoxification (7.5% female) reporting past-month heroin use were surveyed and provided a hair sample to be tested at a later date. While results could not be provided to patients, they were asked how they would respond if informed that their hair tested positive for fentanyl. UHPLC-MS/MS was used to test for past exposure to fentanyl, six other novel synthetic opioids, and fentanyl biomarkers/metabolites. RESULTS:27.5% reported known fentanyl use in the past year and 67.5% reported suspected exposure. 97.5% (39 of 40) tested positive for fentanyl, 90.0% tested positive for 4-ANPP (a biomarker) and norfentanyl (a metabolite); 82.5% tested positive for acetyl-fentanyl, 47.5% tested positive for furanyl-fentanyl, and 7.5% tested positive for U-47700. Most participants (82.5%) reported they would warn others about fentanyl if they learned their hair tested positive; 75.0% reported they would try to stop using heroin, and 65.0% reported they would ensure that someone nearby has naloxone to reverse a potential overdose. CONCLUSIONS:Hair testing is useful in detecting past exposure to fentanyl, its analogs, and other novel synthetic opioids. Further research is needed to determine whether individuals who use heroin learning about exposure affects drug-taking and treatment-seeking behavior.
PMID: 30601034
ISSN: 1097-9891
CID: 3563402

Online training vs in-person training for opioid overdose prevention training for medical students, a randomized controlled trial [Meeting Abstract]

Berland, N; Greene, A; Fox, A; Goldfel, K; Oh, S -Y; Tofighi, B; Quinn, A; Lugassy, D; Hanley, K; De, Souza I
Background: The growing opioid overdose epidemic has grappled the nation with the CDC now reporting that drug overdose deaths have become the most common cause of death for young people. Medical education has historically ignored substance use disorders, and though they generally require all medical students to learn basic life support, they have not taught how to respond to opioid overdoses. Further, medical education is moving towards modalities which utilize adult learning theory. One such modality are online modules. However, there are few studies comparing their outcomes with traditional lectures. Previously, the authors compared in-person and online training of medical students to respond to opioid overdoses using naloxone in a non-randomized controlled setting, which showed no meaningful differences in knowledge, attitudes, and preparedness outcomes for students. In this paper, the authors attempt to use a randomized controlled trial to compare the two educational modalities at a second urban medical school.
Objective(s): The author's primary objective was to demonstrate non-inferiority of online compared to in-person training for knowledge. Our secondary objective were to show non-inferiority of online compared to in-person training attitudes, and preparedness.
Method(s): Our study received IRB exemption as an education intervention. As a part of a transition to clinical clerkships curriculum used for second year medical students, second year medical students in an urban medical school were randomized into training sessions by the office of medical education without foreknowledge of the planned study. Students taking the online training were provided with a link to online modules with pre- and post-tests and video based lectures. Students randomized to the in-person training group took a pre-test just prior to receiving an oral lecture, and then immediately completed a post-test. Paired student's t-tests were used to compare measurements for each group in knowledge, attitudes, and preparedness, and Cohen's D was used to measure the effect size of the change. We calculated 99% confidence intervals for each measure and utilized a margin of non-inferiority of 5%.
Result(s): The in-person group demonstrated a statistically significant increase in knowledge, a non-statistically significant decrease in self-reported preparedness, and a small non-statistically significant increase in attitudes, see Table 1. The online group demonstrated a statistically significant increase in knowledge and self-reported preparedness, without a statistically significant change in attitudes, see Table 1. 99% CIs were [-0.20, 1.09] for knowledge, [6.51, 10.93] for preparedness, and [-2.32, 1.59] for attitudes, see Figure 1.
Conclusion(s): Online training for opioid overdose prevention training provided non-inferior outcomes for knowledge, preparedness, and attitudes. This study supports the use of online opioid overdose prevention training as a non-inferior alternative to in-person training
EMBASE:628976774
ISSN: 1556-9519
CID: 4053502