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1.
Addict Sci Clin Pract ; 19(1): 23, 2024 Apr 02.
Article in English | MEDLINE | ID: mdl-38566249

ABSTRACT

BACKGROUND: Communities That HEAL (CTH) is a novel, data-driven community-engaged intervention designed to reduce opioid overdose deaths by increasing community engagement, adoption of an integrated set of evidence-based practices, and delivering a communications campaign across healthcare, behavioral-health, criminal-legal, and other community-based settings. The implementation of such a complex initiative requires up-front investments of time and other expenditures (i.e., start-up costs). Despite the importance of these start-up costs in investment decisions to stakeholders, they are typically excluded from cost-effectiveness analyses. The objective of this study is to report a detailed analysis of CTH start-up costs pre-intervention implementation and to describe the relevance of these data for stakeholders to determine implementation feasibility. METHODS: This study is guided by the community perspective, reflecting the investments that a real-world community would need to incur to implement the CTH intervention. We adopted an activity-based costing approach, in which resources related to hiring, training, purchasing, and community dashboard creation were identified through macro- and micro-costing techniques from 34 communities with high rates of fatal opioid overdoses, across four states-Kentucky, Massachusetts, New York, and Ohio. Resources were identified and assigned a unit cost using administrative and semi-structured-interview data. All cost estimates were reported in 2019 dollars. RESULTS: State-level average and median start-up cost (representing 8-10 communities per state) were $268,657 and $175,683, respectively. Hiring and training represented 40%, equipment and infrastructure costs represented 24%, and dashboard creation represented 36% of the total average start-up cost. Comparatively, hiring and training represented 49%, purchasing costs represented 18%, and dashboard creation represented 34% of the total median start-up cost. CONCLUSION: We identified three distinct CTH hiring models that affected start-up costs: hospital-academic (Massachusetts), university-academic (Kentucky and Ohio), and community-leveraged (New York). Hiring, training, and purchasing start-up costs were lowest in New York due to existing local infrastructure. Community-based implementation similar to the New York model may have lower start-up costs due to leveraging of existing infrastructure, relationships, and support from local health departments.


Subject(s)
Opiate Overdose , Humans , Delivery of Health Care , Massachusetts , Evidence-Based Practice
2.
Pharmacol Res ; 200: 107078, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38246477

ABSTRACT

Substance use disorders (SUDs) and drug overdose are a public health emergency and safe and effective treatments are urgently needed. Developing new medications to treat them is expensive, time-consuming, and the probability of a compound progressing to clinical trials and obtaining FDA-approval is low. The small number of FDA-approved medications for SUDs reflects the low interest of pharmaceutical companies to invest in this area due to market forces, characteristics of the population (e.g., stigma, and socio-economic and legal disadvantages), and the high bar regulatory agencies set for new medication approval. In consequence, most research on medications is funded by government agencies, such as the National Institute on Drug Abuse (NIDA). Multiple scientific opportunities are emerging that can accelerate the discovery and development of new medications for SUDs. These include fast and efficient tools to screen new molecules, discover new medication targets, use of big data to explore large clinical data sets and artificial intelligence (AI) applications to make predictions, and precision medicine tools to individualize and optimize treatments. This review provides a general description of these new research strategies for the development of medications to treat SUDs with emphasis on the gaps and scientific opportunities. It includes a brief overview of the rising public health toll of SUDs; the justification, challenges, and opportunities to develop new medications; and a discussion of medications and treatment endpoints that are being evaluated with support from NIDA.


Subject(s)
Artificial Intelligence , Nitrosamines , Substance-Related Disorders , Humans , Pharmaceutical Preparations , Research Design , Substance-Related Disorders/drug therapy
3.
Subst Abus ; 44(3): 164-176, 2023 07.
Article in English | MEDLINE | ID: mdl-37287240

ABSTRACT

INTRODUCTION: Reducing substance-related morbidity requires an educated and well-supported workforce. The New England Office Based Addiction Treatment Extension for Community Healthcare Outcomes (NE OBAT ECHO) began in 2019 to support community-based addiction care teams through virtual mentoring and case-based learning. We sought to characterize the program's impact on the knowledge and attitudes of NE OBAT ECHO participants. METHODS: We conducted an 18-month prospective evaluation of the NE OBAT ECHO. Participants registered for 1 of 2 successive ECHO clinics. Each 5-month clinic included ten 1.5-hour sessions involving brief didactic lectures and de-identified patient case presentations. Participants completed surveys at Month-0, -6, -12, and -18 to assess attitudes about working with patients who use drugs and evidence based practices (EBPs), stigma toward people who use drugs, and addiction treatment knowledge. We compared outcomes using 2 approaches: (i) between-groups, which involved comparing the first intervention group to the delayed intervention (comparison) group, and (ii) within-groups, which involved comparing outcomes at different time points for all participants. In the within-group approach, each participant acted as their own control. RESULTS: Seventy-six health professionals participated in the NE OBAT ECHO, representing various roles in addiction care teams. Approximately half (47% [36/76]) practiced primary care, internal, or family medicine. The first intervention group reported improved job satisfaction and openness toward EBPs compared to the delayed intervention group. Within-group analyses revealed that ECHO participation was associated with increased positive perceptions of role adequacy, support, legitimacy, and satisfaction 6 months following program completion. No changes were identified in willingness to adopt EBPs or treatment knowledge. Stigma toward people who use drugs was persistent in both groups across time points. CONCLUSIONS: NE OBAT ECHO may have improved participants' confidence and satisfaction providing addiction care. ECHO is likely an effective educational tool for expanding the capacity of the addiction workforce.


Subject(s)
Health Personnel , Humans , Surveys and Questionnaires , Workforce , New England
4.
J Subst Use Addict Treat ; 152: 209084, 2023 09.
Article in English | MEDLINE | ID: mdl-37302488

ABSTRACT

INTRODUCTION: The economic burden of substance use disorder (SUD) is significant, comprising costs of health care and social services, criminal justice resources, loss of productivity, and premature mortality. This study assembles and synthesizes two decades of evidence describing the benefits of SUD treatment across five main outcome domains; 1) health care utilization; 2) self-reported criminal activity by offense type; 3) criminal justice involvement collected from administrative records or self-reported; 4) productivity assessed through working hours or wages earned; and 5) social services (e.g., a day spent in transitional housing). METHODS: This review included studies if they reported the monetary value of the intervention outcomes, most commonly through a cost-benefit or cost-effectiveness framework. The search included studies from 2003 to the present day as of this writing (up to October 15, 2021). Summary cost estimates were adjusted using the US Consumer Price Index (CPI) to reflect the 12-month benefits per client in USD 2021. We followed the PRISMA methodology for study selection and assessed quality using the Checklist for Health Economic Evaluation Reporting Standards (CHEERS). RESULTS: The databases yielded 729 studies after removing duplicates, and we ultimately selected 12 for review. Studies varied widely regarding analytical approaches, time horizons, outcome domains, and other methodological factors. Among the ten studies that found positive economic benefits, reductions in criminal activity or criminal justice costs represented the largest or second largest component of these benefits (range $621 to $193,440 per client). CONCLUSIONS: Consistent with previous findings, a reduction in criminal activity costs is driven by the relatively high societal cost per criminal offense, notably for violent crimes, such as aggravated assault and rape/sexual assault. Accepting the economic rationale for increased investment in SUD interventions will require recognizing that more benefits accrue to individuals by avoiding being victims of a crime than to governments through budget offsets resulting from savings in non-SUD program expenses. Future studies should explore individually tailored interventions to optimize care management, which may yield unexpected economic benefits to services utilization, and criminal activity data to estimate economic benefits across a broad range of interventions.


Subject(s)
Criminals , Substance-Related Disorders , Humans , Cost-Benefit Analysis , Health Care Costs , Crime , Substance-Related Disorders/therapy
5.
J Subst Use Addict Treat ; 146: 208943, 2023 03.
Article in English | MEDLINE | ID: mdl-36880906

ABSTRACT

BACKGROUND: Given the personal and public consequences of untreated/undertreated OUD among persons involved in the justice system, an increasing number of jails and prisons are incorporating medication for opioid use disorder (MOUD) into their system. Estimating the costs of implementing and sustaining a particular MOUD program is vital to detention facilities, which typically face modest, fixed health care budgets. We developed a customizable budget impact tool to estimate the implementation and sustainment costs of numerous MOUD delivery models for detention facilities. METHODS: The aim is to describe the tool and present an application of a hypothetical MOUD model. The tool is populated with resources required to implement and sustain various MOUD models in detention facilities. We identified resources via micro-costing techniques alongside randomized clinical trials. The resource-costing method is used to assign values to resources. Resources/costs are categorized as (a) fixed, (b) time-dependent, and (c) variable. Implementation costs include (a), (b), and (c) over a specified timeframe. Sustainment costs include (b) and (c). The MOUD model example entails offering all three FDA-approved medications, with methadone and buprenorphine provided by vendors, and naltrexone by the jail/prison facility. RESULTS: Fixed resources/costs are incurred only once, including accreditation fees and trainings. Time-dependent resources/costs are recurring, but fixed over a given time-period; e.g., medication delivery and staff meetings. Variable resources/costs are those that are a direct function of the number of persons treated, such as the medication provided to each patient. Using nationally representative prices, we estimated fixed/sustainment costs to be $2919/patient, over 1 year. This article estimates annual sustainment costs to be $2885/patient. CONCLUSION: The tool will serve as a valuable asset to jail/prison leadership, policymakers, and other stakeholders interested in identifying/estimating the resources and costs associated with alternative MOUD delivery models, from the planning stages through sustainment.


Subject(s)
Jails , Opioid-Related Disorders , Humans , Prisons , Budgets , Opioid-Related Disorders/drug therapy , Methadone/therapeutic use
6.
RSC Adv ; 12(33): 21662-21673, 2022 Jul 21.
Article in English | MEDLINE | ID: mdl-35975050

ABSTRACT

Seven new Casiopeinas® were synthesized and properly characterized. These novel compounds have a general formula [Cu(N-N)(Indo)]NO3, where Indo is deprotonated indomethacin and N-N is either bipyridine or phenanthroline with some methyl-substituted derivatives, belonging to the third generation of Casiopeinas®. Spectroscopic characterization suggests a square-based pyramid geometry and voltammetry experiments indicate that the redox potential is strongly dependent on the N-N ligand. All the presented compounds show high cytotoxic efficiency, and most of them exhibit higher efficacy compared to the well-known cisplatin drug and acetylacetonate analogs of the first generation. Computational calculations show that antiproliferative behavior can be directly related to the volume of the molecules. Besides, a chitosan (CS)-polyacrylamide (PNIPAAm) nanogel was synthesized and characterized to examine the encapsulation and release properties of the [Cu(4,7-dimethyl-1,10-phenanthroline)(Indo)]NO3 compound. The results show good encapsulation performance in acidic conditions and a higher kinetic drug release in acidic media than at neutral pH. This result can be described by the Peppas-Sahlin model and indicates a release mechanism predominantly by Fick diffusion.

7.
Drug Alcohol Depend ; 205: 107639, 2019 12 01.
Article in English | MEDLINE | ID: mdl-31683241

ABSTRACT

INTRODUCTION: The subjective experience of drug craving is a prominent and common clinical phenomenon for many individuals diagnosed with opioid use disorder (OUD), and could be a valuable clinical endpoint in medication development studies. The purpose of this scoping review is to provide an overview and critical analysis of opioid craving assessments located in the published literature examining OUD. METHOD: Studies were identified through a search of PubMed, Embase, and PsychInfo databases and included for review if opioid craving was the focus and participants were diagnosed with or in treatment for OUD. RESULTS: Fifteen opioid craving assessment instruments were identified across the 87 studies included for review. The most common were the Visual Analog Scale (VAS, 41 studies), Desires for Drug Questionnaire (DDQ, 12 studies), Heroin Craving Questionnaire (HCQ, 10 studies), and Obsessive-Compulsive Drug Use Scale (OCDUS, 10 studies). Craving assessments varied considerably in their format, content, time frame, and underlying subscales, and only 6 of 15 had been psychometrically evaluated. DISCUSSION: This review identified a variety of opioid craving assessments, but few had been evaluated for their psychometric properties making it difficult to ascertain whether craving is being assessed optimally in studies of OUD. Thus, the development of a reliable and valid opioid craving assessment would be worthwhile and could be guided by recently published Food and Drug Administration Clinical Outcome Assessment (COA) guidelines. Importantly, a COA focused on opioid craving could be a valuable addition to research studies designed to evaluate novel treatments for OUD.


Subject(s)
Craving , Opioid-Related Disorders/psychology , Surveys and Questionnaires/statistics & numerical data , Humans , Psychometrics
8.
J Pain ; 18(11): 1287-1294, 2017 11.
Article in English | MEDLINE | ID: mdl-28479207

ABSTRACT

Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS). The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of MADDERS as well as SR-MAD. PERSPECTIVE: Identifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 published methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation.


Subject(s)
Analgesics, Opioid/therapeutic use , Clinical Trials as Topic , Opioid-Related Disorders/diagnosis , Prescription Drug Misuse , Clinical Trials as Topic/methods , Humans
9.
Drug Alcohol Depend ; 158: 1-7, 2016 Jan 01.
Article in English | MEDLINE | ID: mdl-26652899

ABSTRACT

BACKGROUND: The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. METHODS: In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. RESULTS AND CONCLUSIONS: Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success.


Subject(s)
Central Nervous System Stimulants/adverse effects , Clinical Trials as Topic/standards , Congresses as Topic , Practice Guidelines as Topic/standards , Substance-Related Disorders/therapy , Amphetamine-Related Disorders/diagnosis , Amphetamine-Related Disorders/therapy , Clinical Trials as Topic/methods , Humans , Substance-Related Disorders/diagnosis , Treatment Outcome
10.
N Engl J Med ; 373(14): 1340-9, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26422724

ABSTRACT

BACKGROUND: The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes. METHODS: We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6. RESULTS: A total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups. CONCLUSIONS: In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products; ClinicalTrials.gov number, NCT01681875.).


Subject(s)
Inhalation Exposure/analysis , Nicotiana/chemistry , Nicotine/standards , Tobacco Products/standards , Tobacco Use Disorder , Biomarkers/urine , Creatinine/urine , Double-Blind Method , Humans , Linear Models , Nicotine/administration & dosage , Nicotine/adverse effects , Substance Withdrawal Syndrome , Tars/analysis , Tars/standards , Tobacco Products/analysis , Tobacco Use Disorder/prevention & control , United States , United States Food and Drug Administration
12.
Pain ; 154(11): 2287-2296, 2013 Nov.
Article in English | MEDLINE | ID: mdl-23792283

ABSTRACT

As the nontherapeutic use of prescription medications escalates, serious associated consequences have also increased. This makes it essential to estimate misuse, abuse, and related events (MAREs) in the development and postmarketing adverse event surveillance and monitoring of prescription drugs accurately. However, classifications and definitions to describe prescription drug MAREs differ depending on the purpose of the classification system, may apply to single events or ongoing patterns of inappropriate use, and are not standardized or systematically employed, thereby complicating the ability to assess MARE occurrence adequately. In a systematic review of existing prescription drug MARE terminology and definitions from consensus efforts, review articles, and major institutions and agencies, MARE terms were often defined inconsistently or idiosyncratically, or had definitions that overlapped with other MARE terms. The Analgesic, Anesthetic, and Addiction Clinical Trials, Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership convened an expert panel to develop mutually exclusive and exhaustive consensus classifications and definitions of MAREs occurring in clinical trials of analgesic medications to increase accuracy and consistency in characterizing their occurrence and prevalence in clinical trials. The proposed ACTTION classifications and definitions are designed as a first step in a system to adjudicate MAREs that occur in analgesic clinical trials and postmarketing adverse event surveillance and monitoring, which can be used in conjunction with other methods of assessing a treatment's abuse potential.


Subject(s)
Clinical Trials as Topic/statistics & numerical data , Opioid-Related Disorders/epidemiology , Opioid-Related Disorders/psychology , Prescription Drug Diversion/classification , Prescription Drug Misuse/classification , Adverse Drug Reaction Reporting Systems , Drug Overdose , Humans , Medication Errors , Opioid-Related Disorders/classification , Prescription Drug Diversion/statistics & numerical data , Prescription Drug Misuse/statistics & numerical data , Suicide, Attempted , Terminology as Topic
13.
Adicciones ; 24(2): 95-103, 2012.
Article in English | MEDLINE | ID: mdl-22648312

ABSTRACT

Drug addictions are complex disorders that require multiple approaches, including the use of pharmacotherapies. Currently, these therapies are based on "small" molecules or chemicals that penetrate the blood-brain barrier, reach the brain, and produce their effects on neurotransmitter systems. Unfortunately, they often do not have the desired efficacy or may cause undesirable side effects, especially at the central nervous system (CNS) level. A novel approach is the use of biologics to treat drug addictions. Biologics are usually complex and "large" molecules, which do not cross the blood-brain barrier and, thus, have no CNS effects. In principle, it appears that the efficacy of biologics to treat drug addiction is by preventing the access of the drug of abuse to the brain, preventing the activation of brain reward systems, and eventually producing the extinction of addiction. Biologic therapeutics includes immunotherapies, such as vaccines or antibodies, as well as enzymes. New products as well as new and more efficient methods of production, are offering vast opportunities to advance the discovery and development of biologics to treat addictions as well as drug overdose. These products include new vaccines with greater specificity and ability to produce antibodies, new methods and techniques to produce vaccines and antibodies, as well as new enzymes with high efficiency to metabolize cocaine. The purpose of the article is to provide a general overview of the development of biologics for the treatment of drug addictions and overdose.


Subject(s)
Biological Products/therapeutic use , Drug Overdose/drug therapy , Substance-Related Disorders/drug therapy , Analgesics, Opioid/poisoning , Cocaine/poisoning , Cocaine-Related Disorders/drug therapy , Humans , Opioid-Related Disorders/drug therapy
14.
Adicciones (Palma de Mallorca) ; 24(2): 95-104, abr.-jun. 2012.
Article in English | IBECS | ID: ibc-101458

ABSTRACT

La adicción a las drogas es un trastorno complejo que requiere diversos abordajes, entre los que está el uso de tratamientos farmacológicos. Actualmente, estas terapias se basan en "pequeñas" moléculas o sustancias químicas que atraviesan la barrera hematoencefálica y actúan sobre los neurotransmisores. Desafortunadamente, con frecuencia no tienen la eficacia deseada o pueden causar efectos secundarios no deseados, que afectan especialmente el sistema nervioso central(SNC). Un enfoque novedoso es el uso de productos biológicos para el tratamiento de la adicción a las drogas. Los productos biológicos son generalmente moléculas complejas y "grandes", que no atraviesan la barrera hematoencefálica y por tanto, no tienen efectos sobre el SNC. En principio, parece que estos productos impiden el acceso de las drogas de abuso al cerebro, con lo cual se previene la activación de los sistemas de recompensa del cerebro y, en consecuencia, se produce la extinción de la adicción. Los tratamientos biológicos incluyen inmunoterapias, tales como las vacunas o los anticuerpos, así como también las enzimas. La aparición de nuevos productos, así como métodos de producción más modernos y eficientes, está posibilitando enormes oportunidades para avanzar en el descubrimiento y desarrollo de productos biológicos para el tratamiento de las adicciones, así como también de las sobredosis por drogas. Estos productos incluyen nuevas vacunas con mayor especificidad y capacidad de producir anticuerpos, nuevos métodos y técnicas para producir vacunas y anticuerpos, y nuevas enzimas butyrylcholinesterases con una alta eficiencia para metabolizar cocaína. El propósito de este artículo es proporcionar una visión general del desarrollo de productos biológicos para el tratamiento de adicción a las drogas y la sobredosis(AU)


Drug addictions are complex disorders that require multiple approaches, including the use of pharmacotherapies. Currently, these therapies are based on "small" molecules or chemicals that penetrate the blood-brain barrier, reach the brain, and produce their effects on neurotransmitter systems. Unfortunately, they often do not have the desired efficacy or may cause undesirable side effects, especially at the central nervous system (CNS) level. A novel approach is the use of biologics to treat drug addictions. Biologics are usually complex and "large" molecules, which do not cross the blood-brain barrier and, thus, have no CNS effects. In principle, it appears that the efficacy of biologics to treat drug addiction is by preventing the access of the drug of abuse to the brain, preventing the activation of brain reward systems, and eventually producing the extinction of addiction. Biologic therapeutics includes immunotherapies, such as vaccines or antibodies, as well as enzymes. New products as well as new and more efficient methods of production, are offering vast opportunities to advance the discovery and development of biologics to treat addictions as well as drug overdose. These products include new vaccines with greater specificity and ability to produce antibodies, new methods and techniques to produce vaccines and antibodies, as well as new enzymes with high efficiency to metabolize cocaine. The purpose of the article is to provide a general overview of the development of biologics for the treatment of drug addictions and overdose(AU)


Subject(s)
Humans , Substance-Related Disorders/diagnosis , Vaccines , Antibodies , Drug Overdose/diagnosis , Drug Overdose/pathology , Biological Products/standards , Biological Products/therapeutic use , Enzymes , Substance-Related Disorders/prevention & control
15.
EXS ; 100: 519-41, 2010.
Article in English | MEDLINE | ID: mdl-20358694

ABSTRACT

Illicit drug intoxications are an increasing public health problem for which, in most cases, no antidotes are clinically available. The diagnosis and treatment of these intoxications requires a trained clinician with experience in recognizing the specific signs and symptoms of intoxications to individual drugs as well as polydrug intoxications, which are more the rule than the exception. To make the diagnosis, the clinical observation and a urine toxicology test are often enough. Evaluating the blood levels of drugs is frequently not practical because the tests can be expensive and results may be delayed and unavailable to guide the establishment of a treatment plan. Other laboratory tests may be useful depending on the drug or drugs ingested and the presence of other medical complications. The treatment should be provided in a quiet, safe and reassuring environment. Vital signs should be closely monitored. Changes in blood pressure, respiratory frequency and temperature should be promptly treated, particularly respiratory depression (in cases of opiate intoxication) or hyperthermia (in cases of cocaine or amphetamine intoxication). Intravenous fluids should be administered as soon as possible. Other psychiatric and medical complication should receive appropriate symptomatic treatment. Research on immunotherapies, including vaccines, monoclonal and catalytic antibodies, seems to be a promising approach that may yield specific antidotes for drugs of abuse, helping to ameliorate the morbidity and mortality associated with illicit drug intoxications.


Subject(s)
Antidotes/therapeutic use , Drug Overdose/therapy , Illicit Drugs/poisoning , Substance-Related Disorders/complications , Drug Overdose/diagnosis , Humans , Predictive Value of Tests , Substance Abuse Detection , Substance-Related Disorders/diagnosis , Treatment Outcome
16.
Rev. colomb. psiquiatr ; 39(Supl): 213S-223S, 2010.
Article in Spanish | LILACS | ID: lil-620235

ABSTRACT

Introducción: Las terapias inmunológicas, ya sea con vacunas (inmunización activa) o con anticuerpos (inmunización pasiva), se están investigando activamente para el manejo de las complicaciones del consumo de drogas de abuso. Objetivo: Revisar el estado actual del desarrollo en la investigación de inmunoterapias contra nicotina, cocaína, heroína, metanfetamina y fenciclidina (PCP), con énfasis en los aspectos clínicos de cada una de ellas. Método: Revisión de la literatura sobre el tema. Resultados: Hasta el momento, las inmunoterapias evaluadas en humanos parecen ser seguras desde el punto de vista médico y con eficacia esperanzadora. Por este mecanismo se previene la activación de los mecanismos de refuerzo cerebral asociados con los efectos adictivos de la droga y, eventualmente, la extinción de la adicción. Conclusión: En teoría, las vacunas también podrían ser útiles en la prevención del desarrollo de la adicción al igual que para prevenir las recaídas del uso de drogas. Los anticuerpos monoclonales parecen ser útiles en el tratamiento de las sobredosis de drogas, porque pueden prevenir los efectos neurotóxicos de las drogas al bloquear su acceso al cerebro. Actualmente, se están investigando vacunas contra la cocaína, heroína, metanfetamina y nicotina. Igualmente se están investigando anticuerpos monoclonales contra la cocaína, metanfetamina, nicotina y PCP...


Introduction: Immunological therapies, either with vaccines (active immunization) or with antibodies (passive immunization), are being actively investigated in the management of complications of drug abuse. Objetive: To review the current state of research development of immunotherapies against nicotine, cocaine, heroin, methamphetamine and phencyclidine (PCP) with an emphasis on the clinical aspects. Method: Review the literature about the topic. Results: So far, immunotherapies evaluated in humans appear to be safe from a medical standpoint and effective. This mechanism prevents the activation of brain reinforcement mechanisms associated with the addictive effects of drugs and, eventually, the extinction of the drug addiction. Conclusion: In theory, vaccines could also be useful in preventing the development of addiction as well as to prevent the relapse of drug use. Currently, vaccines are being investigated against cocaine, heroin, methamphetamine and nicotine. Likewise, monoclonal antibodies are being investigated against cocaine, methamphetamine, nicotine and phencyclidine (PCP)...


Subject(s)
Immunotherapy , Vaccines , Substance-Related Disorders , Therapeutics
17.
Can J Psychiatry ; 54(6): 368-78, 2009 Jun.
Article in English | MEDLINE | ID: mdl-19527557

ABSTRACT

People with mental health and addictive (MHA) disorders smoke at high rates and require tobacco treatment as a part of their comprehensive psychiatric care. Psychiatric care providers often do not address tobacco use among people with mental illness, possibly owing to the belief that their patients will not be able to quit successfully or that even short-term abstinence will adversely influence psychiatric status. Progress in the development of treatments has been slow in part because smokers with current MHA disorders have been excluded from most smoking cessation trials. There are several smoking cessation treatment options, including psychological and pharmacological interventions, that should be offered to people with an MHA disorder who smoke. Building motivation and readiness to quit smoking is a major challenge, and therefore motivational interventions are essential. We review the treatment options for people with tobacco dependence and MHA disorders, offer recommendations on tobacco assessment and tailored treatment strategies, and provide suggestions for future research. Treatment efficacy could be enhanced through promoting smoking reduction as an initial treatment goal, extending duration of treatment, and delivering it within an integrated care model that also aims to reduce the availability of tobacco in MHA treatment settings and in the community.


Subject(s)
Mental Disorders/rehabilitation , Smoking Cessation , Substance-Related Disorders/rehabilitation , Tobacco Use Disorder/rehabilitation , Combined Modality Therapy , Comorbidity , Delivery of Health Care, Integrated , Goals , Humans , Mental Disorders/epidemiology , Secondary Prevention , Smoking/epidemiology , Substance-Related Disorders/epidemiology , Tobacco Use Disorder/epidemiology
18.
Curr Opin Psychiatry ; 22(3): 263-8, 2009 May.
Article in English | MEDLINE | ID: mdl-19307968

ABSTRACT

PURPOSE OF REVIEW: The aim is to compare and contrast psychological treatments for amphetamine and cocaine dependence. RECENT FINDINGS: Stimulant dependence, in the form of cocaine or amphetamine/methamphetamine dependence, is prevalent worldwide, and their ratio may vary across different countries and regions of countries. The treatment of stimulant disorders has greatly advanced in recent years, and scientific evaluation of behavioral therapies, using randomized clinical trials designs and a stage-wise approach, have demonstrated the safety and efficacy of interventions. Psychological interventions such as cognitive behavioral therapy and contingency management for cocaine and methamphetamines use disorders are well tolerated and moderately effective in achieving drug abstinence. There is evidence that contingency management interventions can help to improve retention in treatment and, in turn, other treatment outcomes. Although there are important differences in the neuropsychiatric and medical consequences of cocaine and amphetamine use disorders, there is currently no evidence for a differential treatment effect of any psychosocial treatment in the management of these disorders. SUMMARY: As there are no Food and Drug Administration-approved medications for the treatment of these disorders, psychological interventions form the basis of their treatment. More research is needed to address the specific psychosocial needs of cocaine and amphetamine-dependent individuals in order to improve their treatment outcomes.


Subject(s)
Amphetamine , Central Nervous System Stimulants , Cocaine-Related Disorders/epidemiology , Cocaine-Related Disorders/therapy , Cognitive Behavioral Therapy/methods , Drug Therapy/methods , Substance-Related Disorders/epidemiology , Substance-Related Disorders/therapy , Cocaine-Related Disorders/drug therapy , Humans , Psychology , Substance-Related Disorders/drug therapy
19.
Curr Psychiatry Rep ; 10(5): 392-8, 2008 Oct.
Article in English | MEDLINE | ID: mdl-18803912

ABSTRACT

Recent discoveries about the effects of drugs of abuse on the brain and the mechanisms of their addictions; new chemical compounds, including immunotherapies; and new actions of available medications are offering many opportunities for the discovery and development of novel medications to treat addictive disorders. Furthermore, advancements in the understanding of the genetic and epigenetic basis of drug addiction and the pharmacogenetics of the safety and/or efficacy of the medications are providing opportunities for more individualized pharmacotherapy approaches. Although multiple medications have been investigated for treating addictions, only a handful have shown acceptable safety and efficacy and are approved by the US Food and Drug Administration. This article reviews the current medications that are medically safe and have shown promising results for treating opioid, cocaine, methamphetamine, and cannabis addictions.


Subject(s)
Illicit Drugs , Psychotropic Drugs/therapeutic use , Substance-Related Disorders/rehabilitation , Amphetamine-Related Disorders/rehabilitation , Brain/drug effects , Cocaine-Related Disorders/rehabilitation , Humans , Illicit Drugs/toxicity , Marijuana Abuse/rehabilitation , Methamphetamine/toxicity , Neurotransmitter Agents/metabolism , Opioid-Related Disorders/rehabilitation , Psychotropic Drugs/adverse effects , Substance Withdrawal Syndrome/rehabilitation
20.
Adicciones (Palma de Mallorca) ; 20(2): 111-116, abr.-jun. 2008.
Article in Es | IBECS | ID: ibc-65114

ABSTRACT

Las inmunoterapias en forma de vacunas (inmunización activa) o anticuerpos monoclonales (inmunización pasiva) son propuestas seguras y prometedoras para el tratamiento de ciertos trastornos relacionados con el consumo de sustancias. El mecanismo de acción de la terapia del anticuerpo se realiza por medio de la prevención de la rápida entrada de drogas de abuso en el sistema nervioso central. En teoría, las inmunoterapias pueden tener varias aplicaciones clínicas. Los anticuerpos monoclonales sirven para tratar las sobredosis de drogas y para prevenir los efectos neurotóxicos de las drogas al bloquear el acceso de las drogas al cerebro. Las vacunas ayudan a prevenir el desarrollo de la adicción, a iniciar la abstinencia de drogas en los adictos o a evitar la recaída en el consumo de drogas al reducir los efectos farmacológicos y las propiedades gratificantes de las drogas de abuso en el cerebro. Se ha investigado la inmunización pasiva con anticuerpos monoclonales en la cocaína, la metanfetamina, la nicotina y la penciclidina (PCP). Igualmente, se ha estudiado la inmunización activa con vacunas en la cocaína, la heroína, la metanfetamina y la nicotina. Estas inmunoterapias son prometedoras herramientas terapéuticas y se encuentran en diferentes niveles de desarrollo, a la espera de que las agencias reguladoras las aprueben para el tratamiento de trastornos por consumo de sustancias. El objetivo de este artículo es revisar las propuestas de inmunoterapia existentes, poniendo especial énfasis en los riesgos y beneficios que tienen para el tratamiento de estos trastornos


Immunotherapies in the form of vaccines (active immunization) or monoclonal antibodies (passive immunization) appear safe and a promising treatment approaches for some substance-related disorders. The mechanism of action of the antibody therapy is by preventing the rapid entry of drugs of abuse into the central nervous system. In theory, immunotherapies could have several clinical applications. Monoclonal antibodies may be useful to treat drug overdoses and prevent the neurotoxic effects of drugs by blocking the access of drugs to the brain. Vaccines may help to prevent the development of addiction, initiate drug abstinence in those already addicted to drugs, or prevent drug use relapse by reducing the pharmacological effects and rewarding properties of the drugs of abuse on the brain. Passive immunization with monoclonal antibodies has been investigated for cocaine, methamphetamine, nicotine, and phencyclidine (PCP). Active immunization with vaccines has been studied for cocaine, heroin, methamphetamine, and nicotine. These immunotherapies seem promising therapeutic tools and are at different stages in their development before they can be approved by regulatory agencies for the treatment of substance-related disorders. The purpose of this article is to review the current immunotherapy approaches with emphasis on the risks and benefits for the treatment of these disorders


Subject(s)
Humans , Behavior, Addictive/therapy , Immunotherapy/methods
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