Browsing by Author "Mannelli, Paolo"
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Item Open Access Alcohol and drug use disorders among adults in emergency department settings in the United States.(Annals of emergency medicine, 2012-08) Wu, Li-Tzy; Swartz, Marvin S; Wu, Zunyou; Mannelli, Paolo; Yang, Chongming; Blazer, Dan GImproving identification and treatment for substance use disorders is a national priority, but data about various drug use disorders encountered in emergency departments (EDs) are lacking. We examine past-year substance use and substance use disorders (alcohol, 9 drug classes) among adult ED users. Prevalences of substance use and substance use disorders among ED nonusers are calculated for reference purposes.Using data from the 2007 to 2009 National Surveys on Drug Use and Health, we assessed substance use disorders among noninstitutionalized adults aged 18 years or older who responded to standardized survey questions administered by audio computer-assisted self-interviewing methods.Of all adults (N=113,672), 27.8% used the ED in the past year. ED users had higher prevalences than ED nonusers of coexisting alcohol and drug use (15.2% versus 12.1%), drug use (any drug, 16.9% versus 13.0%; marijuana, 12.1% versus 9.7%; opioids, 6.6% versus 4.1%), and alcohol or drug disorders (11.0% versus 8.5%). Among substance users, the ED group on average spent more days using drugs than the non-ED group; ED users manifested higher conditional rates of substance use disorders than ED nonusers (alcohol or drugs, 15.9% versus 11.7%; marijuana, 16.6% versus 13.2%; cocaine, 33.2% versus 22.3%; opioids, 20.6% versus 10.0%; stimulants, 18.6% versus 9.2%; sedatives, 35.0% versus 4.4%; tranquilizers, 12.4% versus 5.2%). Regardless of ED use status, substance-using young adults, men, and less-educated adults showed increased odds of having a substance use disorder.Drug use is prevalent and combined with high rates of drug use disorders among drug users treated in the ED.Item Open Access An integrated alcohol abuse and medical treatment model for patients with hepatitis C.(Dig Dis Sci, 2012-04) Proeschold-Bell, Rae Jean; Patkar, Ashwin A; Naggie, Susanna; Coward, Lesleyjill; Mannelli, Paolo; Yao, Jia; Bixby, Patricia; Muir, Andrew JBACKGROUND: Patients with chronic hepatitis C virus (HCV) infection have high rates of alcohol consumption, which is associated with progression of fibrosis and lower response rates to HCV treatment. AIMS: This prospective cohort study examined the feasibility of a 24-week integrated alcohol and medical treatment to HCV-infected patients. METHODS: Patients were recruited from a hepatology clinic if they had an Alcohol Use Disorders Identification Test score >4 for women and >8 for men, suggesting hazardous alcohol consumption. The integrated model included patients receiving medical care and alcohol treatment within the same clinic. Alcohol treatment consisted of 6 months of group and individual therapy from an addictions specialist and consultation from a study team psychiatrist as needed. RESULTS: Sixty patients were initially enrolled, and 53 patients participated in treatment. The primary endpoint was the Addiction Severity Index (ASI) alcohol composite scores, which significantly decreased by 0.105 (41.7% reduction) between 0 and 3 months (P < 0.01) and by 0.128 (50.6% reduction) between 0 and 6 months (P < 0.01) after adjusting for covariates. Alcohol abstinence was reported by 40% of patients at 3 months and 44% at 6 months. Patients who did not become alcohol abstinent had reductions in their ASI alcohol composite scores from 0.298 at baseline to 0.219 (26.8% reduction) at 6 months (P = 0.08). CONCLUSION: This study demonstrated that an integrated model of alcohol treatment and medical care could be successfully implemented in a hepatology clinic with significant favorable impact on alcohol use and abstinence among patients with chronic HCV.Item Open Access Association of chronic non-cancer pain status and buprenorphine treatment retention among individuals with opioid use disorder: Results from electronic health record data.(Drug and alcohol dependence reports, 2022-06) John, William S; Mannelli, Paolo; Hoyle, Rick H; Greenblatt, Lawrence; Wu, Li-TzyBackground
Although chronic non-cancer pain (CNCP) is common among individuals with opioid use disorder (OUD), its impact on buprenorphine treatment retention is unclear. The goal of this study was to use electronic health record (EHR) data to examine the association of CNCP status and 6-month buprenorphine retention among patients with OUD.Methods
We analyzed EHR data of patients with OUD who received buprenorphine treatment in an academic healthcare system between 2010 and 2020 (N = 676). We used Kaplan-Meier curves and Cox proportional hazards regression to estimate risk of buprenorphine treatment discontinuation (≥90 days between subsequent prescriptions). We used Poisson regression to estimate the association of CNCP and the number of buprenorphine prescriptions over 6 months.Results
Compared to those without CNCP, a higher proportion of patients with CNCP were of older age and had comorbid diagnoses for psychiatric and substance use disorders. There were no differences in the probability of buprenorphine treatment continuation over 6 months by CNCP status (p = 0.15). In the adjusted cox regression model, the presence of CNCP was not associated with time to buprenorphine treatment discontinuation (HR = 0.90, p = 0.28). CNCP status was associated with a higher number of prescriptions over 6 months (IRR = 1.20, p < 0.01).Conclusions
These findings suggest that the presence of CNCP alone cannot be reliably associated with buprenorphine retention in patients with OUD. Nonetheless, providers should be aware of the association between CNCP and greater psychiatric comorbidity among patients with OUD when developing treatment plans. Research on the influence of additional characteristics of CNCP on treatment retention is needed.Item Open Access Buprenorphine physician-pharmacist collaboration in the management of patients with opioid use disorder: results from a multisite study of the National Drug Abuse Treatment Clinical Trials Network.(Addiction (Abingdon, England), 2021-01-11) Wu, Li-Tzy; John, William S; Ghitza, Udi E; Wahle, Aimee; Matthews, Abigail G; Lewis, Mitra; Hart, Brett; Hubbard, Zach; Bowlby, Lynn A; Greenblatt, Lawrence H; Mannelli, Paolo; Pharm-OUD-Care Collaborative InvestigatorsBackground and aims
Physician and pharmacist collaboration may help address the shortage of buprenorphine-waivered physicians and improve care for patients with opioid use disorder (OUD). This study investigated the feasibility and acceptability of a new collaborative care model involving buprenorphine-waivered physicians and community pharmacists.Design
Nonrandomized, single-arm, open-label feasibility trial.Setting
Three office-based buprenorphine treatment (OBBT) clinics and three community pharmacies in the United States.Participants
Six physicians, six pharmacists, and 71 patients aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) OUD on buprenorphine maintenance.Intervention
After screening, eligible patients' buprenorphine care was transferred from their OBBT physician to a community pharmacist for 6 months.Measurements
Primary outcomes included recruitment, treatment retention and adherence, and opioid use. Secondary outcomes were intervention fidelity, pharmacists' use of prescription drug monitoring program (PDMP), participant safety, and satisfaction with treatment delivery.Findings
A high proportion (93.4%, 71/76) of eligible participants enrolled into the study. There were high rates of treatment retention (88.7%) and adherence (95.3%) at the end of the study. The proportion of opioid-positive urine drug screens (UDSs) among complete cases (i.e. those with all six UDSs collected during 6 months) at month 6 was (4.9%, 3/61). Intervention fidelity was excellent. Pharmacists used PDMP at 96.8% of visits. There were no opioid-related safety events. Over 90% of patients endorsed that they were "very satisfied with their experience and the quality of treatment offered," that "treatment transfer from physician's office to the pharmacy was not difficult at all," and that "holding buprenorphine visits at the same place the medication is dispensed was very or extremely useful/convenient." Similarly, positive ratings of satisfaction were found among physicians/pharmacists.Conclusions
A collaborative care model for people with opioid use disorder that involves buprenorphine-waivered physicians and community pharmacists appears to be feasible to operate in the United States and have high acceptability to patients.Item Open Access Buprenorphine-mediated transition from opioid agonist to antagonist treatment: state of the art and new perspectives.(Current drug abuse reviews, 2012-03) Mannelli, Paolo; Peindl, Kathleen S; Lee, Tong; Bhatia, Kamal S; Wu, Li-TzyConstant refinement of opioid dependence (OD) therapies is a condition to promote treatment access and delivery. Among other applications, the partial opioid agonist buprenorphine has been studied to improve evidence-based interventions for the transfer of patients from opioid agonist to antagonist medications. This paper summarizes PubMed-searched clinical investigations and conference papers on the transition from methadone maintenance to buprenorphine and from buprenorphine to naltrexone, discussing challenges and advances. The majority of the 26 studies we examined were uncontrolled investigations. Many small clinical trials have demonstrated the feasibility of in- or outpatient transfer to buprenorphine from low to moderate methadone doses (up to 60-70 mg). Results on the conversion from higher methadone doses, on the other hand, indicate significant withdrawal discomfort, and need for ancillary medications and inpatient treatment. Tapering high methadone doses before the transfer to buprenorphine is not without discomfort and the risk of relapse. The transition buprenorphine-naltrexone has been explored in several pilot studies, and a number of treatment methods to reduce withdrawal intensity warrant further investigation, including the co-administration of buprenorphine and naltrexone. Outpatient transfer protocols using buprenorphine, and direct comparisons with other modalities of transitioning from opioid agonist to antagonist medications are limited. Given its potential salience, the information gathered should be used in larger clinical trials on short and long-term outcomes of opioid agonist-antagonist transition treatments. Future studies should also test new pharmacological mechanisms to help reduce physical dependence, and identify individualized approaches, including the use of pharmacogenetics and long-acting opioid agonist and antagonist formulations.Item Open Access Cannabis use disorders are comparatively prevalent among nonwhite racial/ethnic groups and adolescents: a national study.(Journal of psychiatric research, 2014-03) Wu, Li-Tzy; Brady, Kathleen T; Mannelli, Paolo; Killeen, Therese K; NIDA AAPI WorkgroupThe racial/ethnic composition of the US population is shifting, with the nonwhite population growing faster than whites. We examined cannabis use disorder (CUD) prevalences and correlates in seven racial/ethnic groups. We included cannabis use (CU) prevalence as a comparison. Data were from the 2005-2011 National Surveys on Drug Use and Health (N = 394,400). Substance use among respondents aged ≥12 years was assessed by computer-assisted, self-interviewing methods. The following were included as control variables: age, sex, family income, government assistance, county type, residential stability, major depressive episode history, arrest history, nicotine dependence, alcohol disorder, and survey year. Past-year CU prevalence increased significantly from 10.45% in 2005 to 11.41-11.54% during 2009-2011. Compared with whites, mixed-race individuals had higher odds of CU; Asian Americans and Hispanics had lower odds of CU. There were no significant yearly changes in CUD prevalence in the sample during 2005-2011 (1.58-1.73%). Compared with whites, individuals who were mixed-race, black, and Native American had higher odds of CUD; Asian Americans had lower odds. In aggregate, 15.35% of past-year cannabis users met criteria for a CUD in the 12-month period. Past-year cannabis users who were black, Native American, Hispanic, or Asian American had higher odds of CUD than white users. In each racial/ethnic group, adolescent cannabis users generally showed greater odds of CUD than adult users. Behavioral health indicators (major depressive episode, arrest history, nicotine dependence, alcohol disorder) were associated with CU and CUD. In conclusion, CUD disproportionally affects nonwhite groups and youth.Item Open Access Clinical epidemiology of substance use disorders: Understanding patterns, sharing knowledge, planning interventions.(The Indian journal of medical research, 2019-04) Mannelli, Paolo; Wu, Li-TzyItem Open Access Commentary on Winhusen et al. (2019): Substance use disorders, chronic diseases, and electronic health records-a paradigm for screening and intervention.(Addiction (Abingdon, England), 2019-08) Mannelli, Paolo; Wu, Li-TzyItem Open Access Comorbid substance use disorders with other Axis I and II mental disorders among treatment-seeking Asian Americans, Native Hawaiians/Pacific Islanders, and mixed-race people.(Journal of psychiatric research, 2013-12) Wu, Li-Tzy; Blazer, Dan G; Gersing, Kenneth R; Burchett, Bruce; Swartz, Marvin S; Mannelli, Paolo; NIDA AAPI WorkgroupLittle is known about behavioral healthcare needs of Asian Americans (AAs), Native Hawaiians/Pacific Islanders (NHs/PIs), and mixed-race people (MRs)-the fastest growing segments of the U.S. population. We examined substance use disorder (SUD) prevalences and comorbidities among AAs, NHs/PIs, and MRs (N = 4572) in a behavioral health electronic health record database. DSM-IV diagnoses among patients aged 1-90 years who accessed behavioral healthcare from 11 sites were systematically captured: SUD, anxiety, mood, personality, adjustment, childhood-onset, cognitive/dementia, dissociative, eating, factitious, impulse-control, psychotic/schizophrenic, sleep, and somatoform diagnoses. Of all patients, 15.0% had a SUD. Mood (60%), anxiety (31.2%), adjustment (30.9%), and disruptive (attention deficit-hyperactivity, conduct, oppositional defiant, disruptive behavior diagnosis, 22.7%) diagnoses were more common than others (psychotic 14.2%, personality 13.3%, other childhood-onset 11.4%, impulse-control 6.6%, cognitive 2.8%, eating 2.2%, somatoform 2.1%). Less than 1% of children aged <12 years had SUD. Cannabis diagnosis was the primary SUD affecting adolescents aged 12-17. MRs aged 35-49 years had the highest prevalence of cocaine diagnosis. Controlling for age at first visit, sex, treatment setting, length of treatment, and number of comorbid diagnoses, NHs/PIs and MRs were about two times more likely than AAs to have ≥ 2 SUDs. Regardless of race/ethnicity, personality diagnosis was comorbid with SUD. NHs/PIs with a mood diagnosis had elevated odds of having SUD. Findings present the most comprehensive patterns of mental diagnoses available for treatment-seeking AAs, NHs/PIs, and MRs in the real-world medical setting. In-depth research is needed to elucidate intraracial and interracial differences in treatment needs.Item Open Access Differences in onset and abuse/dependence episodes between prescription opioids and heroin: results from the National Epidemiologic Survey on Alcohol and Related Conditions.(Subst Abuse Rehabil, 2011-05) Wu, Li-Tzy; Woody, George E; Yang, Chongming; Mannelli, Paolo; Blazer, Dan GOBJECTIVES: To examine patterns of onset and abuse/dependence episodes of prescription opioid (PO) and heroin use disorders in a national sample of adults, and to explore differences by gender and substance abuse treatment status. METHODS: Analyses of data from the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (N = 43,093). RESULTS: Of all respondents, 5% (n = 1815) reported a history of nonmedical PO use (NMPOU) and 0.3% (n = 150) a history of heroin use. Abuse was more prevalent than dependence among NMPOUs (PO abuse, 29%; dependence, 7%) and heroin users (heroin abuse, 63%; dependence, 28%). Heroin users reported a short mean interval from first use to onset of abuse (1.5 years) or dependence (2.0 years), and a lengthy mean duration for the longest episode of abuse (66 months) or dependence (59 months); the corresponding mean estimates for PO abuse and dependence among NMPOUs were 2.6 and 2.9 years, respectively, and 31 and 49 months, respectively. The mean number of years from first use to remission from the most recent episode was 6.9 years for PO abuse and 8.1 years for dependence; the mean number of years from first heroin use to remission from the most recent episode was 8.5 years for heroin abuse and 9.7 years for dependence. Most individuals with PO or heroin use disorders were remitted from the most recent episode. Treated individuals, whether their problem was heroin or POs, tended to have a longer mean duration of an episode than untreated individuals. CONCLUSION: Periodic remissions from opioid or heroin abuse or dependence episodes occur commonly but take a long time. Timely and effective use of treatment services are needed to mitigate the many adverse consequences from opioid/heroin abuse and dependence.Item Open Access Early outcomes following low dose naltrexone enhancement of opioid detoxification.(The American journal on addictions, 2009-03) Mannelli, Paolo; Patkar, Ashwin A; Peindl, Kathleen; Gottheil, Edward; Wu, Li-Tzy; Gorelick, David AAlthough withdrawal severity and treatment completion are the initial focus of opioid detoxification, post-detoxification outcome better defines effective interventions. Very low dose naltrexone (VLNTX) in addition to methadone taper was recently associated with attenuated withdrawal intensity during detoxification. We describe the results of a seven-day follow-up evaluation of 96 subjects who completed inpatient detoxification consisting of the addition of VLNTX (0.125 or 0.250 mg per day) or placebo to methadone taper in a double blind, randomized investigation. Individuals receiving VLNTX during detoxification reported reduced withdrawal and drug use during the first 24 hours after discharge. VLNTX addition was also associated with higher rates of negative drug tests for opioids and cannabis and increased engagement in outpatient treatment after one week. Further studies are needed to test the utility of this approach in easing the transition from detoxification to various follow-up treatment modalities designed to address opioid dependence.Item Open Access Effectiveness of low-dose naltrexone in the post-detoxification treatment of opioid dependence.(Journal of clinical psychopharmacology, 2007-10) Mannelli, Paolo; Patkar, Ashwin A; Peindl, Kathleen; Murray, Heather W; Wu, Li-Tzy; Hubbard, RobertBACKGROUND: The clinical use of naltrexone (NTX) in the treatment of opioid dependence has been limited because of poor compliance and inconsistent outcomes. In particular, the therapeutic benefit of extended treatment with NTX after opioid detoxification is unclear. The present study evaluated whether the augmentation with low-dose NTX during the post-detoxification treatment of opioid dependence would improve outcomes. METHODS: In an open-label naturalistic design, 435 opioid-dependent patients who had completed inpatient detoxification were offered the choice of entering 1 of the 2 outpatient treatment arms: clonidine extended treatment (CET) (clonidine + psychosocial treatment), or enhanced extended treatment (EET) (oral NTX [1-10 mg/d] + CET) for 21 days. The primary outcome measure was retention in treatment. Secondary outcomes included abstinence from opioids, dropouts, and adherence to postdischarge care. RESULTS: One hundred sixty-two patients (37.2%) accepted EET. Subjects receiving EET stayed longer in the program (F = 64.4; P = 0.000), were less likely to drop out, used less opioids, and followed through with referral to long-term outpatient treatment in a higher number, compared with patients in the CET arm (P = 0.000 in each case). The NTX + clonidine combination was safe and well tolerated. CONCLUSIONS: This preliminary study indicates the potential benefit of augmentation with low-dose NTX to improve outcomes after opioid detoxification for a preferred group of patients. Randomized controlled trials are necessary to further evaluate the role of low-dose NTX in the outpatient treatment of opioid dependence.Item Open Access Evaluating brief screeners to discriminate between drug use disorders in a sample of treatment-seeking adults.(General hospital psychiatry, 2013-01) Wu, Li-Tzy; Swartz, Marvin S; Pan, Jeng-Jong; Burchett, Bruce; Mannelli, Paolo; Yang, Chongming; Blazer, Dan GOBJECTIVE:The objective was to identify a potential core set of brief screeners for the detection of individuals with a substance use disorder (SUD) in medical settings. METHOD:Data were from two multisite studies that evaluated stimulant use outcomes of an abstinence-based contingency management intervention as an addition to usual care (National Drug Abuse Treatment Clinical Trials Network trials 006-007). The sample comprised 847 substance-using adults who were recruited from 12 outpatient substance abuse treatment settings across the United States. Alcohol and drug use disorders were assessed by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Checklist. Data were analyzed by factor analysis, item response theory (IRT), sensitivity and specificity procedures. RESULTS:Comparatively prevalent symptoms of dependence, especially inability to cut down for all substances, showed high sensitivity for detecting an SUD (low rate of false negative). IRT-defined severe (infrequent) and low discriminative items, especially withdrawal for alcohol, cannabis and cocaine, had low sensitivity in identifying cases of an SUD. IRT-defined less severe (frequent) and high discriminative items, including inability to cut down or taking larger amounts than intended for all substances and withdrawal for amphetamines and opioids, showed good-to-high values of area under the receiver operating characteristic curve in classifying cases and noncases of an SUD. CONCLUSION:Findings suggest the feasibility of identifying psychometrically reliable substance dependence symptoms to develop a two-item screen for alcohol and drug disorders.Item Open Access Extended release naltrexone injection is performed in the majority of opioid dependent patients receiving outpatient induction: a very low dose naltrexone and buprenorphine open label trial.(Drug and alcohol dependence, 2014-05) Mannelli, Paolo; Wu, Li-Tzy; Peindl, Kathleen S; Swartz, Marvin S; Woody, George EThe approval of extended release injectable naltrexone (XR-NTX; Vivitrol(®)) has introduced a new option for treating opioid addiction, but studies are needed to identify its place within the spectrum of available therapies. The absence of physiological opioid dependence is a necessary and challenging first step for starting XR-NTX. Outpatient detoxification gives poor results and inpatient detoxification is either unavailable or too brief for the physiological effects of opioids to resolve. Here we present findings from an open label study that tested whether the transition from opioid addiction to XR-NTX can be safely and effectively performed in an outpatient setting using very low dose naltrexone and buprenorphine.Twenty treatment seeking opioid addicted individuals were given increasing doses of naltrexone starting at 0.25mg with decreasing doses of buprenorphine starting at 4 mg during a 7-day outpatient XR-NTX induction procedure. Withdrawal discomfort, craving, drug use, and adverse events were assessed daily until the XR-NTX injection, then weekly over the next month.Fourteen of the 20 participants received XR-NTX and 13 completed weekly assessments. Withdrawal, craving, and opioid or other drug use were significantly lower during induction and after XR-NTX administration compared with baseline, and no serious adverse events were recorded.Outpatient transition to XR-NTX combining upward titration of very low dose naltrexone with downward titration of low dose buprenorphine was safe, well tolerated, and completed by most participants. Further studies with larger numbers of subjects are needed to see if this approach is useful for naltrexone induction.Item Open Access Family substance use screening: less to hide, more to gain.(Indian J Med Res, 2016-06) Mannelli, Paolo; Wu, Li-TzyItem Open Access Hallucinogen use disorders among adult users of MDMA and other hallucinogens.(The American journal on addictions, 2008-09) Wu, Li-Tzy; Ringwalt, Christopher L; Mannelli, Paolo; Patkar, Ashwin AWe investigated the prevalence, patterns, and correlates of past-year DSM-IV hallucinogen use disorders (HUDs) among past-year users of MDMA and other hallucinogens from a sample of Americans 18 or older (n = 37,227). Users were categorized as MDMA users and other hallucinogen users. Overall, one in five (20%) MDMA users and about one in six (16%) other hallucinogen users reported at least one clinical feature of HUDs. Among MDMA users, prevalence of hallucinogen abuse, subthreshold dependence, and dependence was 4.9%, 11.9%, and 3.6%, respectively. The majority with hallucinogen abuse displayed subthreshold dependence. Most with hallucinogen dependence exhibited abuse. Subthreshold hallucinogen dependence is relatively prevalent and represents a clinically important subgroup that warrants future research and consideration in a major diagnostic classification system.Item Open Access Opioid use disorder deaths and the effects of medication therapy.(The American journal of drug and alcohol abuse, 2019-01) Mannelli, Paolo; Wu, Li-TzyItem Open Access Patient perspectives on community pharmacy administered and dispensing of methadone treatment for opioid use disorder: a qualitative study in the U.S.(Addiction science & clinical practice, 2023-08) Wu, Li-Tzy; John, William S; Mannelli, Paolo; Morse, Eric D; Anderson, Alyssa; Schwartz, Robert PBackground
Pharmacy administration and dispensing of methadone treatment for opioid use disorder (PADMOUD) may address inadequate capability of opioid treatment programs (OTPs) in the US by expanding access to methadone at community pharmacies nationally. PADMOUD is vastly underutilized in the US. There is no published US study on OUD patients' perspectives on PADMOUD. Data are timely and needed to inform the implementation of PADMOUD in the US to address its serious opioid overdose crisis.Methods
Patient participants of the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were interviewed to explore implementation-related factors for PADMOUD. All 20 participants of the parent study were invited to participate in this interview study. Each interview was recorded and transcribed verbatim. Thematic analysis was conducted to identify emergent themes.Results
Seventeen participants completed the interview. Patients' perspectives on PADMOUD were grouped into five areas. Participants reported feasibility of taking the tablet formulation of methadone at the pharmacy and identified benefits from PADMOUD (e.g., better access, efficiency, convenience) compared with usual care at the OTP. Participants perceived support for PADMOUD from their family/friends, OTP staff, and pharmacy staff. PADMOUD was perceived to be a great option for stable patients with take-home doses and those with transportation barriers. The distance (convenience), office hours, and the cost were considered factors most influencing their decision to receive methadone from a pharmacy. Nonjudgmental communication, pharmacists' training on methadone treatment, selection of patients (stable status), workflow of PADMOUD, and protection of privacy were considered key factors for improving operations of PADMOUD.Conclusion
This study presents the first findings on patient perspectives on PADMOUD. Participants considered pharmacies more accessible than OTPs, which could encourage more people to receive methadone treatment earlier and help transition stable patients from an OTP into a local pharmacy. The findings have timely implications for informing implementation strategies of PADMOUD that consider patients' views and needs.Item Open Access Pharmacological enhancement of naltrexone treatment for opioid dependence: a review.(Subst Abuse Rehabil, 2011-06) Mannelli, Paolo; Peindl, Kathleen S; Wu, Li-TzyPURPOSE: Opioid dependence (OD) is a serious and growing clinical condition with increasing social costs that requires expanding treatment beyond opioid agonist substitution. The opioid antagonist naltrexone has displayed a remarkable association of theoretical effectiveness and poor clinical utility in treating OD due to noncompliant behavior and low acceptability among patients, only partly modified by psychosocial interventions. We reviewed pharmacological studies, including naltrexone depot formulations and combination treatments. METHOD: We searched PubMed for clinical studies on the use of naltrexone implants and slow-release injections in OD, and investigations using adjunct medications to improve naltrexone maintenance therapy of OD. We discussed the results in view of their application to the clinical practice. RESULTS: Significant reduction in opioid use and improved retention in treatment have been found in several studies using depot naltrexone formulations, some of which are controlled clinical trials. Pilot investigations have gathered initial positive results on the use of naltrexone in combination with serotonin reuptake inhibitors, α-2 adrenergic, opioid, and γ-aminobutyric acid agonist medications. CONCLUSION: Current evidence suggests that more research on effectiveness and safety is needed in support of depot naltrexone treatment for OD. Further research comparing slow-release with oral naltrexone and opioid agonist medications will help characterize the role of opioid antagonist-mediated treatment of OD. Preliminary investigations on naltrexone combination treatments suggest the opportunity to continue study of new mixed receptor activities for the treatment of OD and other drug addictions.Item Open Access Pharmacy-based methadone treatment in the US: views of pharmacists and opioid treatment program staff.(Substance abuse treatment, prevention, and policy, 2023-09) Wu, Li-Tzy; Mannelli, Paolo; John, William S; Anderson, Alyssa; Schwartz, Robert PBackground
The US federal regulations allow pharmacy administration and dispensing of methadone for opioid use disorder (PADMOUD) to increase the capability of opioid treatment programs (OTPs) in providing methadone maintenance treatment (MMT) for opioid use disorder (OUD) as part of a medication unit. However, there is a lack of research data from both pharmacy and OTP staff to inform the implementation of PADMOUD.Methods
Staff of a pharmacy (n = 8) and an OTP (n = 9) that participated in the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were recruited to participate in this qualitative interview study to explore implementation-related factors for PADMOUD. Each interview was recorded and transcribed verbatim. NVivo was used to help identify themes of qualitative interview data. The Promoting Action on Research Implementation in Health Services (PARIHS) framework was used to guide the coding and interpretation of data.Results
Six pharmacy staff and eight OTP staff (n = 14) completed the interview. Results based on PARIHS domains were summarized, including evidence, context, and facilitation domains. Participants perceived benefits of PADMOUD for patients, pharmacies, OTPs, and payers. PADMOUD was considered to increase access for stable patients, provide additional patient service opportunities and revenues for pharmacies/pharmacists, enhance the capability of OTPs to treat more new patients, and reduce patients' cost when receiving medication at a pharmacy relative to an OTP. Both pharmacy and OTP staff were perceived to be supportive of the implementation of PADMOUD. Pharmacy staff/pharmacists were perceived to need proper training on addiction and methadone as well as a protocol of PADMOUD to conduct PADMOUD. Facilitators include having thought leaders to guide the operation, a certification program to ensure proper training of pharmacy staff/pharmacist, having updated pharmacy service software or technology to streamline the workflow of delivering PADMOUD and inventory management, and reimbursement for pharmacists.Conclusion
This study presents the first findings on perspectives of PADMOUD from both staff of a community pharmacy and an OTP in the US. Finding on barriers and facilitators are useful data to guide the development of strategies to implement PADMOUD to help address the US opioid crisis.