Automated Reinforcement Management System (ARMS): focused phase I provider feedback.

BACKGROUND: Alcohol use increases risk for morbidity and mortality and is associated with over 3 million annual deaths worldwide. Contingency Management (CM) is one of the most effective interventions for substance use disorders, and has recently been coupled with technologies to promote novel treatments for alcohol use disorders (AUD). Leveraging these technological advances, we are developing the Automated Reinforcement Management System (ARMS), an integrated CM system designed to enable CM treatment as a component of a digital therapeutic or adjunct therapy remotely to anyone with a smartphone. OBJECTIVE: To collect detailed provider feedback on ARMS and determine the need for modifications to make the system most feasible, acceptable, and useful to providers. METHODS: Seven providers completed one-hour structured interviews/focus groups wherein we described the ARMS system and its application to clinical care. Providers viewed screen shots of the ARMS provider facing and patient facing systems. Providers gave feedback on their current AUD treatment practices, preferences for the functionality and appearance of the system, preferences for receipt of information on their patients, why they and their patients would or would not use the system, suggestions for improvement, and the proposed intervention overall. To analyze the qualitative data gathered, we used a qualitative descriptive approach with content analysis methods. RESULTS: The overarching theme of Individualized Treatment emerged throughout the interviews. This sentiment supports use of ARMS, as it is intended to supplement provider communication and intervention as an adjunctive and customizable tool with the ability to reach rural patients, not a stand-alone option. Themes of Accountability and Objective Assessment arose during discussions of why people would use the system. Themes within provider obstacles included, Information Overload and Clinical Relevance, and in patient obstacles, Sustained Engagement and Security Concerns. Two themes emerged regarding suggestions for improvement: Increasing Accessibility and Bi-directional Communication. DISCUSSION: Themes from provider input are being used to modify ARMS to make it more user friendly, time saving, and relevant to treatment of AUD. If successful, ARMS will provide effective, individualized-digital therapeutic for those needing adjunctive treatment or those living in rural remote areas needing better connected care.

Sociodemographic and clinical profile of crack cocaine treatment-seeking individuals living in "Crackland", Brazil / Perfil sociodemográfico e clínico de indivíduos em busca de tratamento para o uso de crack que vivem na "Cracolândia"

OBJECTIVE: São Paulo's Crackland is the biggest and oldest open drug use scene in Brazil, yet little is known about the profile of crack cocaine treatment-seeking individuals living in this region. The aim of this crossectional study was to describe the demographics and clinical characteristics of treatment-seeking crack users living in the Crackland region. METHODS: A sample of nighty eight individuals were screened for DSM-V substance use disorders, including substance use, impulsiveness, and psychiatric symptoms. Recent crack cocaine use was also tested using biologic specimens. RESULTS: Results indicated severe social vulnerability, as participants experienced high rates of homelessness (46.9%), unstable housing (50%), unemployment (60.4%) and early school drop-out (27.5%). The average age of crack use onset was 20 years (SD = 6.9) and the mean duration of continuous crack use was 15 years (SD = 9.7). Most participants presented with concomitant mental health disorders, particularly alcohol use disorder (87.8%), as well high rates of psychiatric symptomatology and impulsiveness. More than half of the sample reported at least one previous inpatient (73.5%) and outpatient (65.3%) addiction treatment attempt. CONCLUSION: This population profile should inform mental healthcare services, promoting the provision of tailored assistance by targeting specific demands at all levels of treatment.

OBJETIVO: Localizada em São Paulo, a Cracolândia é o maior e mais antigo cenário aberto de uso de drogas do Brasil. Ainda assim, pouco se sabe sobre o perfil dos indivíduos que vivem nessa região e buscam tratamento para crack. O objetivo deste estudo transversal foi descrever características demográficas e clínicas de usuários de crack vivendo na região da Cracolândia que estão em busca de tratamento. MÉTODOS: Noventa e oito indivíduos foram avaliados para transtornos por uso de substâncias do DSM-V, padrão de uso de substâncias, impulsividade e sintomatologia psiquiátrica. O uso recente de crack também foi determinado por meio de coleta de amostras toxicológicas. RESULTADOS: Os resultados indicaram grave vulnerabilidade social, com significativas prevalências de falta de moradia (46,9%), moradia instável (50%), desemprego (60,4%) e abandono escolar precoce (27,5%). A idade média de início do uso de crack foi de 20 anos (DP = 6,9) e a duração média do uso contínuo do crack foi de 15 anos (DP = 9,7). A maioria dos participantes apresentou alguma comorbidade psiquiátrica, particularmente transtorno por uso de álcool (87,8%), bem como altas taxas de sintomatologia psiquiátrica e impulsividade. Mais da metade da amostra relatou pelo menos uma tentativa anterior de tratamento por internação (73,5%) e ambulatorial (65,3%). CONCLUSÃO: Os achados desse estudo permitem um maior entendimento do perfil e das necessidades de usuários de crack vivendo na região da Cracolândia e podem ajudar serviços de saúde especializados em dependência química a promoverem uma assistência mais direcionada às demandas específicas dessa população.

Acceptability and feasibility of incorporating contingency management into a public treatment program for homeless crack cocaine users in Brazil: A pilot study.

Homeless substance users are particularly hard to treat. In this pilot study, we evaluated the acceptability and feasibility of incorporating Contingency Management (CM) into a public Abstinent-Contingent Housing (ACH) treatment program developed to treat currently homeless crack cocaine users. A total of 21 homeless crack cocaine users were randomized to receive 12 weeks of ACH alone (n = 9) or ACH plus CM (ACH + CM) (n = 12). Twelve treatment providers in the ACH treatment program were trained to deliver the CM intervention. CM was rated as relatively (41.7%) or very (58.3%) easy to understand and relatively (50%) or very (50%) easy to conduct by the ACH treatment providers. On a 10-point Likert scale, providers rated the importance of incorporating CM into public treatment programs for crack cocaine at M = 8.3 (SD = 2). Participants exposed to CM rated as relatively (33.3%) or very (66.7%) easy to understand. One hundred percent liked receiving the intervention "a lot," and 78.9% believed it helped them achieve and maintain crack cocaine abstinence. Finally, compared to the ACH condition, the ACH + CM condition was consistently associated with better treatment retention and cocaine use outcome measures, yelling small to large effect sizes. However, possibly due to the small sample size, most of these differences did not achieve statistical significance. CM was well integrated into the ACH treatment program and was well accepted by both the providers and participants, suggesting the feasibility of incorporating CM into a public treatment program for homeless crack cocaine users from low- and middle-income countries. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Effectiveness of incorporating contingency management into a public treatment program for people who use crack cocaine in Brazil. A single-blind randomized controlled trial.

BACKGROUND: Smoked cocaine (i.e., crack use) is a severe health problem in Brazil, with the country being reported as having the largest crack market in the world. The objective of this study was to evaluate the effectiveness of incorporating Contingency Management targeting cocaine abstinence into a public treatment program in Brazil. METHODS: Single-blind randomized controlled trial conducted at Unidade Recomeço Helvétia (URH), a public ambulatory treatment program for persons who use crack and live in the "Crackland" region in downtown São Paulo, Brazil. In total, 98 treatment-seeking individuals who use crack were randomized to one of two treatment conditions. Participants allocated to the control condition (n = 48) received 12 weeks of the standard treatment provided at URH. Participants allocated to the experimental condition (n = 50) received the same treatment in combination with Contingency Management (URH+CM). In URH+CM, participants were provided with vouchers with monetary value for submission of negative cocaine urinalysis twice weekly. RESULTS: Compared to the URH group, the URH+CM group was significantly more likely to submit a negative cocaine urinalysis during treatment, with odds ratios ranging from 4.17 to 6.78, depending on how missing data was accounted for (p<0.01). Participants receiving Contingency Management also had higher odds of achieving three or more weeks of continuous abstinence (OR= 8.07; 95% CI [2.48, 26.24]), achieved longer durations of abstinence (B = 2.14; 95% CI [0.67, 3.61]), submitted a higher percentage of negative urinalysis (B = 19.85; 95% CI [6.89, 32.82]), and were retained in treatment for a longer period (B = 3.00; 95% CI [1.04, 4.97]), compared to those receiving URH alone (p<0.01 for all). CONCLUSIONS: The incorporation of Contingency Management was effective in promoting cocaine abstinence and treatment retention. The large-scale dissemination of Contingency Management may be an effective strategy to treat Brazilians with cocaine use disorders.

Validating the clinical relevance of alternative stimulant use treatment outcome measures by examining their association with 3-month follow-up outcomes.

The lack of a consensus on empirically supported and clinically meaningful outcome measures for stimulant use disorders (SUDs) continues to undermine the development and evaluation of effective behavioral and pharmacological treatment options. The aim of this study was to evaluate the clinical relevance of four stimulant use treatment outcome measures (longest duration of abstinence [LDA], percent of negative urinalysis submitted, abstinent in the last 2 weeks of treatment, and three or more weeks of continuous abstinence) by exploring their utility via association with stimulant and alcohol use, employment and legal problems, and severity of psychiatric symptomatology collected at follow-up. Data used in these secondary analyses came from a multisite randomized contingency management treatment trial for SUDs (n = 441) conducted through the NIDA Clinical Trials Network. Multiple regression analyses were conducted to explore the association of four stimulant use treatment outcome measures and eight 3-month follow-up outcomes. The percent of negative urinalysis outcomes showed the most consistent performance compared to alternative outcomes, being significantly associated with better responses in all eight 3-month follow-up outcomes (ß range: -169 to -241, p < .01). Both dichotomous outcome measures showed similar performances being significantly associated with four follow-up outcomes (ß range: -159 to -203, p < .01). All outcome measures were consistently associated with better outcome responses at the 3-month follow-up, adding support to their clinical relevance and their adoption in SUD treatment trials. The two dichotomous outcome measures are reliable candidates to be used as endpoint outcomes, as recommended by the U.S. Food and Drug Administration (FDA). (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Long-term functioning to provide empirical support for the clinical relevance of treatment outcomes for methamphetamine use disorders.

BACKGROUND: Research has yet to empirically evaluate methamphetamine (MA) use outcome measures commonly used to indicate treatment success. Clinically meaningful outcomes must be associated with long-term functioning in important life domains. This study evaluated the association between different MA use outcomes and long-term life-functioning. METHOD: The data that this study used in its secondary analyses were pooled from two treatment trials for MA use disorders (n = 237). The study conducted multiple regression analyses (with multiple imputation for missing data) to determine the association of six within-treatment MA use outcome measures with problem severity in seven life domains and a proxy measure for overall functioning, measured with the Addiction Severity Index (ASI) and assessed at an 8-month follow-up. RESULTS: The longest duration of abstinence (LDA) outcome achieved the most consistent performance, being associated with better scores in five of eight ASI outcomes (ß ranging from -0.203 to -0.291; p < .01). The complete abstinence during treatment demonstrated the poorest performance and was not significantly associated with any of the ASI outcomes. All other MA use outcome measures were significantly (p < .01) associated with at least one ASI outcome. CONCLUSION: This study provides empirical support for the use of LDA as a clinically relevant indicator of treatment success for MA use disorders, while also indicating the limitations of using complete abstinence during treatment to determine treatment success. Based on these findings, providers and researchers should use LDA as a primary outcome for MA use disorder treatments and trials.

Clinical validation of reduction in cocaine frequency level as an endpoint in clinical trials for cocaine use disorder.

BACKGROUND: Despite calls for non-abstinence endpoints in randomized clinical trials (RCTs) for cocaine use disorder, there is a lack of data validating non-abstinence endpoints. We conducted a clinical validation of reduction in cocaine frequency level as a non-abstinence endpoint in RCTs for cocaine use disorder (CUD). METHODS: We utilized a pooled dataset (n = 716; 63.6 % male, 51.4 % non-Hispanic white) from seven RCTs for CUD. We specified three cocaine frequency levels at baseline and end of treatment (EOT): abstinence, low frequency (1-4 days/month), and high frequency (5+ days/month). Multiple regression analyses were conducted. RESULTS: Among the sample, 38.3 % had at least a one-level reduction from baseline to EOT, whereas 61.7 % did not change/increased frequency level. At least a one-level reduction in cocaine frequency level from baseline to EOT versus no change/increase was significantly associated with better functioning up to one year following treatment on measures of cocaine use, as well as psychological, employment, legal, and other drug use problem severity domains of the Addiction Severity Index (ASI). We also conducted analyses only among those at the high frequency level at baseline and found those who reduced to low frequency use at EOT had similar outcomes at follow-up as those who reduced to abstinence. CONCLUSIONS: At least a one-level reduction in cocaine frequency level from pretreatment to EOT can be a clinically meaningful endpoint given its relation to sustained clinical benefit up to one-year following treatment. These data parallel recent findings regarding reduction in drinking risk level among individuals with alcohol use disorder.

Sociodemographic and clinical outcome differences among individuals seeking treatment for cocaine use disorders. The intersection of gender and race.

BACKGROUND: Most published treatment trials for cocaine use disorders (CUD) have been conducted with samples composed predominantly of White men and underrepresent women and racial/ethnic minorities. Because of the high prevalence of men and White individuals in CUD treatment trials, results from studies that have compared treatment outcomes by gender and race or ethnicity separately may not be representative of women or racial/ethnic minorities. METHODS: With a sample pooled from seven randomized clinical trials of treatment for CUD (n = 629), baseline characteristics and treatment outcome responses were compared with 4 subgroups of individuals created based on the intersection of gender and race (White men, Black men, White women and Black women). RESULTS: At baseline, sociodemographic status, pattern, frequency and severity of cocaine use, psychiatric comorbidities, employment and legal problems significantly differed across groups. Treatment outcome indicators collected during treatment and through follow-up, consistently indicated poorer outcomes among the sample of White women, but were similar for the other groups. CONCLUSIONS: Men and women with CUD from both racial groups enter treatment with different psychosocial issues (e.g., history of violence/trauma, financial problems, co-occurring psychiatric disorders) and substance use problems (e.g. types of substances) that may impact treatment outcomes and indicate a need for culturally-informed care to deliver more effective treatment for CUD. Poorer overall outcomes among White women may reflect the need for a more focused treatment approach for this group; and highlight the importance of evaluating gender and race in treatment trials to better address health disparities.

Change in employment status and cocaine use treatment outcomes: A secondary analysis across six clinical trials.

BACKGROUND: Unemployment is a chronic problem among treatment seeking substance users and is associated with poor treatment response. Most studies that have examined the relationship between employment and treatment outcomes for substance use disorders have done so by considering employment at only one specific point in time (e.g., upon entering treatment). There is a lack of research on how change in employment status over time is associated with substance use treatment outcomes. The aim of this study was to evaluate both static employment status and change in employment status over time as predictors of cocaine use treatment outcomes. METHODS: We utilized data pooled from six randomized clinical trials evaluating treatment for cocaine use disorders (n = 553). Multiple general linear mixed models were conducted to determine the association of baseline, end-of-treatment, and change in employment status (from baseline to end-of-treatment) with treatment outcomes. RESULTS: Treatment outcomes did not differ by baseline employment status but were significantly better for those employed versus unemployed at the end-of-treatment. In regard to change in employment status over time, those who were unemployed at baseline and acquired employment by end-of-treatment had significantly better treatment outcomes during active treatment and follow-up, as compared to those who were unemployed at baseline and remained unemployed by end-of-treatment. CONCLUSION: Our findings suggest that end-of-treatment employment status may be an important marker of good outcome among those unemployed at treatment entry and support the incorporation of interventions designed to promote employment by substance use disorders treatment programs.

Short and long-term improvements in psychiatric symptomatology to validate clinically meaningful treatment outcomes for cocaine use disorders.

BACKGROUND: Substantial efforts have been made to identify clinically meaningful non-abstinence cocaine use outcomes by establishing associations between targeted drug use outcomes and long-term functional improvements. Psychiatric symptomatology is prevalent among those seeking treatment for cocaine use disorder (CUD). Establishing an association between cocaine use outcomes and improvements in psychiatric symptomatology would support clinical validity to these outcome measures. METHOD: With data pooled from 5 clinical trials evaluating treatment for CUD (n = 474) multiple linear mixed models were conducted to determine how five specific cocaine use outcome measures performed in terms of improvements in psychiatric symptomatology assessed with the Brief Symptom Inventory (BSI) at baseline, end-of-treatment and 6-month follow-up. RESULTS: Three outcome measures performed comparably well (maximum days of consecutive abstinence, 3 or more weeks of abstinence and end-of-treatment abstinence), in that they consistently predicted improvements in several BSI composite scores at the end-of-treatment and follow-up. The poorer-performing outcome measures were complete abstinence during treatment, percentage of negative urinalysis results and percentage of days abstinent. Improvements in the BSI's global index of distress, positive symptom total, as well as depression, interpersonal sensitivity, obsessive-compulsion, phobic-anxiety and psychoticism dimensions were consistently associated with outcome effects, while anxiety, hostility, paranoid ideation and somatization were not. CONCLUSION: The consistent short and long-term association of three outcome measures evaluated here (maximum days of consecutive abstinence, 3 or more weeks of abstinence and end-of-treatment abstinence) with improvements psychiatric symptomatology adds support to their clinical relevance as well as their adoption in trials and treatments for CUD.

Sociodemographic Characteristics, Patterns of Crack Use, Concomitant Substance Use Disorders, and Psychiatric Symptomatology in Treatment-Seeking Crack-Dependent Individuals in Brazil.

Crack cocaine (crack) dependence is a severe disorder associated with considerable morbidity and mortality, constituting a major public health problem in Brazil. The aim of this study was to improve understanding of the profile of treatment-seeking crack-dependent individuals. We recruited 65 crack-dependent individuals from among those seeking treatment at an outpatient clinic for alcohol and drug treatment in the city of São Paulo, Brazil. Assessments, conducted between August 2012 and July 2014, focused on sociodemographic characteristics, the pattern/history of crack use, treatment history, concomitant substance use disorders, psychiatric symptomatology, and impulsivity. In the study sample, males predominated, as did unemployment, homelessness, and low levels of education. On average, the participants had smoked crack for 10 years. Most had previously been treated for crack dependence. Concomitant DSM-IV diagnoses of dependence on other substances were common, dependence on tobacco and alcohol being the most prevalent. Participants presented significant psychiatric symptomatology and impulsivity, with nearly half of the sample presenting psychotic symptoms, 90% presenting depressive symptoms, and 80% presenting anxiety symptoms. Most treatment-seeking crack-dependent individuals in Brazil are living in extremely poor social conditions and are struggling with the severe, chronic, and comorbid features of this disorder.

Crack cocaine users views regarding treatment with contingency management in Brazil.

BACKGROUND: Contingency management (CM) has recently shown efficacy in promoting abstinence and retention in treatment among crack cocaine users in Brazil. However, partially because of unawareness and resistance among health care providers, CM has not been widely employed. The objective of this study was to conduct a secondary analysis in order to evaluate how CM participants perceive their treatment experience. METHODS: Twenty-seven crack cocaine users, previously assigned to 12 weeks of CM treatment, were assessed with a structured questionnaire designed to assess their personal opinion of, difficulty in understanding, and acceptance of the CM intervention, as well as their opinion regarding its impact on their treatment responses. RESULTS: Descriptive analyses showed that 92.6% of the participants found it very easy to understand the CM protocol. All participants reported liking their CM experience quite a bit. For the perceived effects of CM on their treatment response, 81.5% of the participants stated that CM helped them considerably, the mean score for the impact of CM on treatment response (out of a maximum of 10) being 9 (SD = 1.5). When asked if they believed CM could help other people with crack cocaine dependence, 92.6% of the participants stated that CM could help such people a lot and 7.4% stated that it could help them a little. CONCLUSIONS: From the perspective of the patients, CM was easily assimilated, easily accepted, and had a direct positive effect on treatment response. These findings provide additional support for the incorporation of CM into substance abuse treatment services in Brazil.

Contingency management targeting abstinence is effective in reducing depressive and anxiety symptoms among crack cocaine-dependent individuals.

Although contingency management (CM) is effective in promoting abstinence and treatment retention among crack cocaine users who meet the criteria for cocaine dependence, less is known about its off-target effects. In this secondary analysis, we evaluated the impact of CM on depressive and anxiety symptoms in a sample of cocaine-dependent individuals under treatment. Sixty-five crack cocaine users who met the criteria for cocaine dependence were randomly assigned to receive 12 weeks of standard treatment alone (STA; n = 32) or 12 weeks of standard treatment plus CM (STCM; n = 33). The outcome measures of the secondary analysis were depressive and anxiety symptoms assessed with the Beck Depression Inventory-II (BDI-II) and the Beck Anxiety Inventory (BAI). At baseline, 59 (90.8%) of the participants reported at least mild depressive symptoms and 47 (72.5%) reported at least mild anxiety symptoms. The mean BDI-II (24.5 ± 12.1) and BAI (20.7 ± 13.5) scores in the sample as a whole was moderate. After treatment, the reported levels of depressive symptoms (ß = -9.6, p < .05) and anxiety symptoms (ß = -9.9, p < .05) were lower among the individuals receiving STCM than among those receiving STA. This study provides evidence that an STCM intervention targeting crack cocaine abstinence also produces significant reductions in depressive and anxiety symptoms. This low cost intervention also demonstrated significant promise and optimization potential for crack cocaine users in a setting of scarce resources and high mental health comorbidity. Relevance Statement: We found that the prevalence of depressive and anxiety symptoms were extremely high among crack cocaine users, and that, among such individuals, contingency management (CM) reduced depressive and anxiety symptomatology to a greater degree than did standard treatment. Our results suggest that CM targeting crack cocaine abuse can have off-target effects on psychiatric symptomatology. (PsycINFO Database Record

Contingency management is effective in promoting abstinence and retention in treatment among crack cocaine users in Brazil: A randomized controlled trial.

Crack cocaine dependence has become a severe public health problem in Brazil, and current psychosocial approaches to this problem have shown little or no effectiveness. Although contingency management is among the most effective behavioral treatments for substance use disorders, it has never been applied in the treatment of crack cocaine-dependent individuals in Brazil. The aim of this study was to evaluate the efficacy of incorporating contingency management into standard outpatient treatment for crack cocaine dependence, as well as the impact that doing so has on treatment attendance, retention in treatment, maintenance of abstinence, and the frequency of substance use. We evaluated 65 treatment-seeking, crack cocaine-dependent individuals, randomized to receive 12 weeks of standard treatment plus contingency management (STCM; n = 33) or 12 weeks of standard treatment alone (STA; n = 32). Those in the STCM group received monetary incentives for being abstinent, earning up to US$235.50 if they remained abstinent throughout the entire treatment period. The STCM group participants attended a mean of 19.5 (SD = 14.9) treatment sessions, compared with 3.7 (SD = 5.9) for the STA group participants (p < .01). Those in the STCM group were 3.8, 4.6, and 68.9 times more likely to be retained in treatment at weeks 4, 8, and 12 than were those in the STA group. The likelihood of detecting 4, 8, and 12 weeks of continuous abstinence was 17.7, 9.9, and 18.6 times higher in the STCM group than in the STA group (p < .05). Compared to the STA group, the STCM group submitted a significantly higher proportion of negative samples for crack cocaine, delta-9-tetrahydrocannabinol, and alcohol (p < .001) when all expected samples were included in the denominator but not when only submitted samples were considered. The average monthly cost/participant for incentives was $29.00. Contingency management showed efficacy in a sample of Brazilian crack cocaine users. The intervention holds promise for broader application in international settings. (PsycINFO Database Record