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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
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
Buprenorphine added on brief cognitive behavioral therapy for treatment of methamphetamine use disorder
Shariatirad, S; Mahjoub, A; Haqiqi, A; Hemami, M R; Tofighi, B; Ekhtiari, H; Effatpanah, M
Background: Methamphetamine (MA) use remains a major public health concern around the world. Recent findings suggest that buprenorphine may be helpful for cocaine use reduction. Moreover, animal studies described reduced dopamine peak effect following MA use, due to the administration of low dose buprenorphine. Objectives: This study examined the effectiveness of buprenorphine with brief cognitive behavioral therapy on MA use disorder. Methods: The study was conducted in an outpatient substance abuse treatment center in Qazvin, Iran. Nineteen MA users received buprenorphine for 24 weeks combined with brief cognitive behavioral therapy in an outpatient substance abuse treatment program, three times per week, as a before and after non - randomization study. Clinical outcomes included treatment retention, MA use, degree of MA dependency and craving, quality of life, cognitive abilities questionnaire, addiction severity and also adverse events. Data was analyzed by performing repeated measures analysis and the Friedman test for nonparametric variables. Results: Fifteen participants completed the study during six months and frequency of MA use was significantly decreased at 24 weeks (P < 0.001). There were also significant reductions in craving (P < 0.001), degree of MA dependence (P < 0.001), and improvements in quality of life, cognitive ability, and some subscales of addiction severity. Conclusions: The results of this preliminary clinical study demonstrated that buprenorphine could potentially attenuateMAcraving and alternate rewarding effects of MAand had promising effects on cognitive impairment. Furthermore, buprenorphine can be considered as a harm reduction intervention in some communities, in which the people, as a result of cultural beliefs, do not accept a therapy, which only consists of counseling and no medications.
EMBASE:622952703
ISSN: 1735-8639
CID: 3205102
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 rates of medication adherence, retention, good clinical outcomes (Aim 1), and cost savings (Aim 2). Methods: This is an on-going 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 a DSM-V diagnosis of AUD randomized to XR-NTX (380 mg/month) vs. O-NTX (50-100 mg/day).Medical Management visits occur biweekly (weeks 1-8), then monthly.Major research assessments occur at baseline, weeks 13, 25, 48. The primary outcome is a Good Clinical Outcome (GCO) across weeks 5-24: abstinence or moderate drinking and 0-2 days of heavy drinking per month. This preliminary, descriptive analysis presentsWeek 0-5 results among all participants. Results: N = 237 participants were randomized from 6/14-9/17: mean age 48.5 (SD = 10.6); 71% male; 54% AA, 21%Hispanic; 41% employed, 81%reported other lifetime substance use. Mean AUDIT scores (instrument range 0-40) at baseline: 24.2 (SD = 8.0); mean OCDS (range 0-40) scores 17.1 (SD = 8.1); mean drinks/day 9.6 (SD = 11.6) with 29%abstinent vs. 61% heavy drinking days. Medication induction was robust, 115 of 117 (98.2%) initiating XR-NTX and 120 (100%) filled or received an initial O-NTX prescription. The GCO was reported by 41%XR-NTX and 47%ONTX atWeek 5. DuringWeek 1-5, mean drinks/day were 3.1 (SD = 6.1), 63% abstinent/22%heavy drinking days for XR-NTX; 2.4 (SD = 4.03), 61%abstinent/22%heavy drinking days for O-NTX. 62%received XR-NTX injection #2 and 67%received O-NTXmonthly refill #2. Adherence self-report for O-NTX at Week 5 indicated moderate average daily adherence,MMAS-8 mean (range <6 low, 6 to <8 moderate, =8 high) score 6.13 (SD = 3.02). Conclusion: This on-going XR vs. oral naltrexone alcohol primary care treatment trial recruited a primarily male, unemployed, ethnic minority adult population. Initial acceptance of both XR and ONTX was high. Primary outcomes will focus on drinking reductions and cost and value comparisons during weeks 5-24
EMBASE:622675985
ISSN: 1530-0277
CID: 3193762
The Role of Technology-Based Interventions for Substance Use Disorders in Primary Care: A Review of the Literature
Tofighi, Babak; Abrantes, Ana; Stein, Michael D
The burden of alcohol and drug use disorders (substance use disorders [SUDs]) has intensified efforts to expand access to cost-effective psychosocial interventions and pharmacotherapies. This article provides an overview of technology-based interventions (eg, computer-based and Web-based interventions, text messaging, interactive voice recognition, smartphone apps, and emerging technologies) that are extending the reach of effective addiction treatments both in substance use treatment and primary care settings. It discusses the efficacy of existing technology-based interventions for SUDs, prospects for emerging technologies, and special considerations when integrating technologies in primary care (eg, privacy and regulatory protocols) to enhance the management of SUDs.
PMID: 29933825
ISSN: 1557-9859
CID: 3158422
A comparative analysis of online vs in-person opioid overdose prevention training for first year medical students as an adjunct to first responder training using cardiopulmonary resuscitation [Meeting Abstract]
Berland, N; Lugassy, D; Fox, A D; Tofighi, B; Hanley, K
Study Objectives: To help address the growing opioid overdose epidemic and help teach a core toxicological emergency, the authors taught the use of naloxone as an antidote to an opioid overdose, for all first-year medical students as a part of first responder training using cardiopulmonary resuscitation, as an online and in-person training over three years. Previously we demonstrated that in-person opioid overdose prevention training as an adjunct to BLST improves knowledge and preparedness. To compare the educational outcomes; knowledge, preparedness, and attitudes, for online vs in-person opioid overdose prevention training. Methods: Opioid overdose prevention trainings were conducted in person in 2014 and 2015, and online in 2016. First year students completed pre-and post-training surveys covering three measures: knowledge (11-point scale), attitudes (66-point scale) towards patients with opioid use disorders, and self-reported preparedness (60-point scale) to respond to an opioid overdose. Online and in-person scores across all three measures were compared using analysis of covariance (ANCOVA) methods across two years of trainings. Results: After controlling for pre-test scores, there were very small and not meaningful differences in attitude and knowledge scores between in-person training and online training. The estimated difference for knowledge was-0.06 (95% CI-0.48-0.35) and for attitudes was 0.64 (95% CI-0.22-1.50). The average scores related to preparedness were higher for the students who took the course online, estimated at 2.10 points (95% CI 0.97-3.22). Feedback was generally positive, with 96% of the in-person group saying future classes should receive the training and 95% of the online group saying all medical schools should provide the training. Conclusions: Online training has become a more common method of medical education due to its many advantages including standardization, scalability and flexibility to accommodate asynchronous learning. However, few studies have performed analyses of online training vs in-person training for relative effectiveness. The authors have demonstrated that for training medical students to administer naloxone as an antidote to an opioid overdose, online training is comparable to in-person training. These results support the use of online training for adding training on administering naloxone
EMBASE:620857742
ISSN: 1097-6760
CID: 2968022
Text message reminders for improving patient appointment adherence in an office-based buprenorphine program: A feasibility study
Tofighi, Babak; Grazioli, Frank; Bereket, Sewit; Grossman, Ellie; Aphinyanaphongs, Yindalon; Lee, Joshua David
BACKGROUND AND OBJECTIVES: Missed visits are common in office-based buprenorphine treatment (OBOT). The feasibility of text message (TM) appointment reminders among OBOT patients is unknown. METHODS: This 6-month prospective cohort study provided TM reminders to OBOT program patients (N = 93). A feasibility survey was completed following delivery of TM reminders and at 6 months. RESULTS: Respondents reported that the reminders should be provided to all OBOT patients (100%) and helped them to adhere to their scheduled appointment (97%). At 6 months, there were no reports of intrusion to their privacy or disruption of daily activities due to the TM reminders. Most participants reported that the TM reminders were helpful in adhering to scheduled appointments (95%), that the reminders should be offered to all clinic patients (95%), and favored receiving only TM reminders rather than telephone reminders (95%). Barriers to adhering to scheduled appointment times included transportation difficulties (34%), not being able to take time off from school or work (31%), long clinic wait-times (9%), being hospitalized or sick (8%), feeling sad or depressed (6%), and child care (6%). CONCLUSIONS: This study demonstrated the acceptability and feasibility of TM appointment reminders in OBOT. Older age and longer duration in buprenorphine treatment did not diminish interest in receiving the TM intervention. Although OBOT patients expressed concern regarding the privacy of TM content sent from their providers, privacy issues were uncommon among this cohort. Scientific Significance Findings from this study highlighted patient barriers to adherence to scheduled appointments. These barriers included transportation difficulties (34%), not being able to take time off from school or work (31%), long clinic lines (9%), and other factors that may confound the effect of future TM appointment reminder interventions. Further research is also required to assess 1) the level of system changes required to integrate TM appointment reminder tools with already existing electronic medical records and appointment records software; 2) acceptability among clinicians and administrators; and 3) financial and resource constraints to healthcare systems. (Am J Addict 2017;XX:1-6).
PMID: 28799677
ISSN: 1521-0391
CID: 2664212
Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature
Tofighi, Babak; Nicholson, Joseph M; McNeely, Jennifer; Muench, Frederick; Lee, Joshua D
ISSUES: Mobile phone use has increased dramatically and concurrent with rapid developments in mobile phone-based health interventions. The integration of text messaging interventions promises to optimise the delivery of care for persons with substance dependence with minimal disruption to clinical workflows. We conducted a systematic review to assess the acceptability, feasibility and clinical impact of text messaging interventions for persons with illicit drug and alcohol dependence. APPROACH: Studies were required to evaluate the use of text messaging as an intervention for persons who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition criterion for a diagnosis of illicit drug and/or alcohol dependence. Authors searched for articles published to date in MEDLINE (pubmed.gov), the Cochrane Library, EMBASE, CINAHL, Google Scholar and PsychINFO. KEY FINDINGS: Eleven articles met the search criteria for this review and support the acceptability and feasibility of text messaging interventions for addressing illicit drug and alcohol dependence. Most studies demonstrated improved clinical outcomes, medication adherence and engagement with peer support groups. Text messaging interventions also intervened on multiple therapeutic targets such as appointment attendance, motivation, self-efficacy, relapse prevention and social support. IMPLICATIONS: Suggestions for future research are described, including intervention design features, clinician contact, privacy measures and integration of behaviour change theories. CONCLUSION: Text messaging interventions offer a feasible platform to address a range of substances (i.e. alcohol, methamphetamine, heroin and alcohol), and there is increasing evidence supporting further larger-scale studies. [Tofighi B, Nicholson JM, McNeely J, Muench F, Lee JD. Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature. Drug Alcohol Rev 2017;00:000-000].
PMID: 28474374
ISSN: 1465-3362
CID: 2546862