Discontinuation of medication treatment for opioid use disorder after a successful course: The discontinuation phase of the CTN-0100 (RDD) trial.

INTRODUCTION AND BACKGROUND: Buprenorphine, and extended-release naltrexone, are effective in decreasing opioid use, morbidity and mortality. The available evidence suggests that these medications should be used for long term treatment; however, patients often ask how long they need to be on medication, and whether it would be safe to discontinue. There are sparse data to guide us. The CTN-0100 trial will address this gap in our knowledge by studying participants who have decided to discontinue buprenorphine and extended-release naltrexone for OUD. RESEARCH DESIGN AND METHODS: The trial is a multicenter, randomized, non-blinded study. Participants are stable adult volunteers, on sublingual buprenorphine, extended-release buprenorphine, or extended-release naltrexone, expressing an interest in discontinuing medication. Participants on buprenorphine must be stable for at least 1 year and participants on extended-release naltrexone must be stable for at least 6 months. Participants are engaged in the study for up to 96 weeks, including a flexible taper period, and are then transitioned to follow-up within the trial. All participants are randomly assigned to the study Medical Management (MM) or to MM plus Connections (CHESS health) digital smartphone application aimed at recovery and abstinence (MMD). Sublingual Buprenorphine participants are also randomized (2 × 2 design) to a taper using either sublingual or extended-release buprenorphine. DISCUSSION/CONCLUSION: It is hoped that this trial will provide a rich source of data on management of patients discontinuing medication for opioid use disorder (MOUD) to inform future research and practice. The trial will shed light on which strategies are most likely to lead to long-term success (absence of relapse), and what participant characteristics distinguish those who can safely discontinue MOUD from those who remain at risk of relapse should they discontinue. CLINICALTRIALS: gov Identifier: NCT04464980.

A randomized clinical trial of strengths-based case management to link emergency department patients to opioid use disorder treatment.

BACKGROUND: Despite the existence of effective pharmacotherapies, rates of opioid use disorder and opioid overdose deaths have continued to increase. Emergency department (ED) visits provide an important opportunity to engage in treatment patients with untreated opioid use disorder (OUD). Case management implemented in other settings is effective in linking those with opioid and other drug use disorders to longer-term treatment, but research has not established its efficacy in the ED. Here we report the results of a trial of Strengths-Based Case Management (SBCM) for people with untreated OUD who are identified during ED visits, with the primary goal of linking them to pharmacologic treatment. METHODS: The study identified patients with untreated OUD during a treatment episode at a large urban ED. The study randomly assigned three hundred participants in 1:1 ratio to receive SBCM or screening, assessment, and referral (SAR) to OUD treatment. Those assigned to SBCM received up to six sessions of SBCM with the primary goal of linkage to treatment. Primary outcomes were initiation of treatment and engagement in pharmacotherapy for OUD. The study defined a "successful outcome" for opioid use as a 3-month urine negative for illicit opioids and no more than 2 days of self-reported opioid misuse in the 4 weeks prior to the 3-month interview. RESULTS: Rates of treatment initiation were not significantly different in the SBCM and SAR groups (57.4% vs. 49.7%, respectively, p > 0.05), nor did engagement in pharmacotherapy differ significantly between groups (p > 0.05). During the 90 days following the index ED visit, SBCM and SAR participants engaged in pharmacotherapy for a mean of 21.8% (SD = 35.1%) versus 17.7% (SD = 31.0%) of days, respectively. Likewise, no significant difference occurred between groups in rates of "successful opioid use outcome" as defined a priori (p > 0.05), although self-reported opioid use over the entire 6-month follow-up period was lower in the SBCM group (10.8 vs. 13.4 days/month, p = 0.042). CONCLUSIONS: SBCM-ED did not improve OUD treatment initiation and engagement in this ED study. Although these findings do not necessarily generalize to all EDs, other approaches, such as direct referral or initiation of treatment in the ED, have considerable empirical support, and should be implemented where they are feasible.

Time-lagged association between counseling and/or 12-Step attendance with subsequent opioid use in a secondary analysis from a randomized, clinical trial of medications for opioid use disorder.

Introduction: Psychosocial support is recommended in conjunction with medication for opioid use disorder (MOUD), although optimal "dose," modality, and timing of participation is not established. This study comprised a secondary analysis of counseling and 12-Step attendance and subsequent opioid use in a MOUD randomized clinical trial. Methods: The parent study randomly assigned 570 participants to receive buprenorphine-naloxone (BUP-NX, n=287) or extended-release injectable naltrexone (XR-NTX, n=283). Mixed-effects logistic regression models were fit with opioid use as the response variable, and a counseling/12-Step attendance predictor. Differences by treatment assignment were examined. Results: Any counseling or 12-Step attendance was associated with reduced odds of opioid use at the subsequent visit, whether considered individually or aggregated across type. A continuous relationship was observed for 12-Step attendance (F(1,5083)=5.01, p=.025); with each additional hour associated with 13% (95% CI: 0.83, 0.90) reduction in odds of opioid use. The strength of this association grew over time. In the BUP-NX arm, group counseling was associated with a greater reduction in odds of opioid use than for XR-NTX, (OR=0.32 (95% CI: .22, 0.48) vs. OR=0.69 (95% CI: 0.43, 1.08)). For XR-NTX, 12-Step was associated with a greater reduction in odds of opioid use (OR=0.35 (95% CI: 0.22, 0.54) vs. OR=0.65 (95% CI: 0.47, 0.89) for BUP-NX)). Conclusions: Psychosocial engagement has a proximal association with opioid use, the strength of that association may grow with dose and time. Alternatively, more motivated individuals may both attend more counseling/12-Step and have better treatment outcomes, or the relationship may be reciprocal.

Patients' perspectives on initiating treatment with extended-release naltrexone (XR-NTX).

BACKGROUND: The National Drug Abuse Treatment Clinical Trials Network (CTN) multisite comparative-effectiveness study ("X:BOT") by Lee et al. (2018) found that, once initiated, extended-release naltrexone (XR-NTX) is as similarly safe and effective as sublingual buprenorphine-naloxone (BUP-NX) for the treatment of opioid use disorder (OUD). However, the detoxification hurdle makes XR-NTX much more difficult to initiate than BUP-NX. This hurdle highlights the need to better understand how patients transition from active opioid use to XR-NTX treatment. OBJECTIVE: To explore patient-identified barriers and facilitators to initiating antagonist treatment (XR-NTX) within the context of an inpatient hospital setting and to reflect postdischarge experiences of those who did and did not initiate XR-NTX treatment. METHOD: We used a convenience sampling strategy to identify study candidates, with the intention of recruiting approximately an equal number of medication-initiated and noninitiated patients. Study participants (N = 14) included 13 males and 1 female with OUD randomized to the XR-NTX arm of the X:BOT study at 1 of the 8 study sites. Seven participants in this sample initiated XR-NTX treatment, and seven did not. Each participant completed one semistructured qualitative interview. We analyzed transcripts using deductive and inductive approaches to conventional content analysis. RESULTS: Although the majority of participants viewed opioid blockade, once-monthly dosing, and no dependence or withdrawal as favorable attributes of XR-NTX, participant ambivalence and lack of familiarity with antagonist treatment were barriers to treatment initiation. The long duration of action and the perceived "commitment" to the medication (e.g., "At the time, a month sounded like a year") compounded the patients' concerns and ambivalence. The majority of those who initiated XR-NTX described it as an effective treatment for OUD, with treatment satisfaction and sustained abstinence emerging as central themes among this population. Some participants who did not successfully initiate XR-NTX expressed regret and a willingness to try XR-NTX in the future. CONCLUSION: Achieving full opioid detoxification is one, but not the only, barrier to initiating treatment with XR-NTX. Additional participant-identified barriers to XR-NTX initiation include fears and ambivalence regarding antagonist treatment. Once initiated, participants perceive XR-NTX to be an effective treatment for maintaining abstinence from opioids. XR-NTX appealed to participants due to the autonomy it affords with once-monthly dosing and no physical dependence.

Implementation of strength-based case management for opioid-dependent patients presenting in medical emergency departments: rationale and study design of a randomized trial.

BACKGROUND: As the USA grapples with an opioid epidemic, medical emergency departments (EDs) have become a critical setting for intervening with opioid-dependent patients. Brief interventions designed to bridge the gap from acute ED care to longer-term treatment have shown limited efficacy for this population. Strength-based case management (SBCM) has shown strong effects on treatment linkage among patients with substance use disorders in other healthcare settings. This study aimed to investigate whether SBCM is an effective model for linking opioid-dependent ED patients with addiction treatment and pharmacotherapy. Here, we describe the implementation and challenges of adapting SBCM for the ED (SBCM-ED). Study rationale, design, and baseline characteristics are also described. METHODS: This study compared the effects of SBCM-ED to screening, assessment, and referral alone (SAR) on treatment linkage, substance use, and functioning. We recruited participants from a public hospital in NYC. Working alliance between case managers and participants and the feasibility of SBCM implementation were evaluated. Baseline data from the randomized sample were analyzed for group equivalency. Outcomes analyses are forthcoming. RESULTS: Three hundred adult participants meeting DSM-IV criteria for opioid dependence were randomly assigned to either SBCM, in which they received a maximum of six case management sessions within 90 days of enrollment, or SAR, in which they received a comprehensive referral list and pamphlet outlining drug use consequences. No significant differences were found between groups at baseline on demographic or substance use characteristics. All SAR participants and 92.6% of SBCM-ED participants initiated their assigned intervention. Over half of SBCM-ED first sessions occurred in the ED on the day of enrollment. Case managers developed a strong working alliance with SBCM-ED participants after just one session. CONCLUSION: Interventions that exceed SBIRT were accepted by an opioid-dependent patient population seen in an urban medical ED. At the time of study funding, this trial was one of the first to focus specifically on this population in this challenging setting. The successful implementation of SBCM demonstrates its adaptability to the ED and may serve as a potential model for EDs seeking to adopt an intervention that overcomes the barrier between the ED encounter and more intensive treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT02586896 . Registered on 27 October 2015.

Interventions for children affected by war: an ecological perspective on psychosocial support and mental health care.

BACKGROUND: Children and adolescents exposed to armed conflict are at high risk of developing mental health problems. To date, a range of psychosocial approaches and clinical/psychiatric interventions has been used to address mental health needs in these groups. AIMS: To provide an overview of peer-reviewed psychosocial and mental health interventions designed to address mental health needs of conflict-affected children, and to highlight areas in which policy and research need strengthening. METHODS: We used standard review methodology to identify interventions aimed at improving or treating mental health problems in conflict-affected youth. An ecological lens was used to organize studies according to the individual, family, peer/school, and community factors targeted by each intervention. Interventions were also evaluated for their orientation toward prevention, treatment, or maintenance, and for the strength of the scientific evidence of reported effects. RESULTS: Of 2305 studies returned from online searches of the literature and 21 sources identified through bibliography mining, 58 qualified for full review, with 40 peer-reviewed studies included in the final narrative synthesis. Overall, the peer-reviewed literature focused largely on school-based interventions. Very few family and community-based interventions have been empirically evaluated. Only two studies assessed multilevel or stepped-care packages. CONCLUSIONS: The evidence base on effective and efficacious interventions for conflict-affected youth requires strengthening. Postconflict development agendas must be retooled to target the vulnerabilities characterizing conflict-affected youth, and these approaches must be collaborative across bodies responsible for the care of youth and families.

Psychosocial adjustment and mental health in former child soldiers--systematic review of the literature and recommendations for future research.

AIMS AND SCOPE: This article reviews the available quantitative research on psychosocial adjustment and mental health among children (age <18 years) associated with armed forces and armed groups (CAAFAG)--commonly referred to as child soldiers. METHODS: PRISMA standards for systematic reviews were used to search PubMed, PsycInfo, JSTOR, and Sociological Abstracts in February 2012 for all articles on former child soldiers and CAAFAG. Twenty-one quantitative studies from 10 countries were analyzed for author, year of publication, journal, objectives, design, selection population, setting, instruments, prevalence estimates, and associations with war experiences. Opinion pieces, editorials, and qualitative studies were deemed beyond the scope of this study. Quality of evidence was rated according to the systematic assessment of quality in observational research (SAQOR). FINDINGS: According to SAQOR criteria, among the available published studies, eight studies were of high quality, four were of moderate quality, and the remaining nine were of low quality. Common limitations were lack of validated mental health measures, unclear methodology including undefined sampling approaches, and failure to report missing data. Only five studies included a comparison group of youth not involved with armed forces/armed groups, and only five studies assessed mental health at more than one point in time. Across studies, a number of risk and protective factors were associated with postconflict psychosocial adjustment and social reintegration in CAAFAG. Abduction, age of conscription, exposure to violence, gender, and community stigma were associated with increased internalizing and externalizing mental health problems. Family acceptance, social support, and educational/economic opportunities were associated with improved psychosocial adjustment. CONCLUSIONS: Research on the social reintegration and psychosocial adjustment of former child soldiers is nascent. A number of gaps in the available literature warrant future study. Recommendations to bolster the evidence base on psychosocial adjustment in former child soldiers and other war-affected youth include more studies comprising longitudinal study designs, and validated cross-cultural instruments for assessing mental health, as well as more integrated community-based approaches to study design and research monitoring.

Annual Research Review: Mental health and resilience in HIV/AIDS-affected children-- a review of the literature and recommendations for future research.

BACKGROUND: To date, research on mental health in HIV-affected children (children who have an HIV-positive caregiver or live with the virus themselves) has focused on risk factors associated with the disease. However, simultaneous identification of factors that contribute to resilience in the face of risks is also needed. A greater understanding of modifiable protective processes that contribute to resilience in the mental health of children affected by HIV can inform the design of interventions that bolster naturally occurring supports and contribute to early prevention or better management of risks. METHODS: We reviewed the recent literature on mental health and resilience in children and adolescents affected by HIV/AIDS. Literature searches of PsycInfo and PubMed were conducted during July-December 2011 consistent with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards. Qualitative and quantitative studies were included for review if primary research questions pertained to mental health and coping or protective processes in children and families affected by HIV/AIDS. All studies subject to full review were evaluated for quality using a modified Systematic Assessment of Quality in Observational Research (SAQOR) rating system. RESULTS: One hundred and seventy one unique studies were returned from online searches of the literature and bibliography mining. Of these, 29 were evaluated as pertaining directly to mental health and resilience in families and children living with HIV/AIDS. Eight studies presented qualitative analyses. Ten quantitative studies examined individual resources contributing to child resilience and four quantitative studies looked at family-level resources. Ten studies also investigated community level interactions. Four presented findings from resilience-focused interventions. CONCLUSIONS: There is a clear need for rigorous research on mental health and resilience in HIV-affected children and adolescents. The evidence base would greatly benefit from more standardized and robust approaches to thinking about resilience from an ecological perspective inclusive of resources at multiple levels and their interactions.

Validating the Center for Epidemiological Studies Depression Scale for Children in Rwanda.

OBJECTIVE: We assessed the validity of the Center for Epidemiological Studies Depression Scale for Children (CES-DC) as a screen for depression in Rwandan children and adolescents. Although the CES-DC is widely used for depression screening in high-income countries, its validity in low-income and culturally diverse settings, including sub-Saharan Africa, is unknown. METHOD: The CES-DC was selected based on alignment with local expressions of depression-like problems in Rwandan children and adolescents. To examine criterion validity, we compared CES-DC scores to depression diagnoses on a structured diagnostic interview, the Mini International Neuropsychiatric Interview for Children (MINI KID), in a sample of 367 Rwandan children and adolescents aged 10 through 17 years. Caregiver and child or adolescent self-reports endorsing the presence of local depression-like problems agahinda kenshi (persistent sorrow) and kwiheba (severe hopelessness) were also examined for agreement with MINI KID diagnosis. RESULTS: The CES-DC exhibited good internal reliability (α = .86) and test-retest reliability (r = .85). The area under the receiver operating characteristic curve for the CES-DC was 0.825 when compared to MINI KID diagnoses, indicating a strong ability to distinguish between depressed and nondepressed children and adolescents in Rwanda. A cut point of≥30 corresponded with a sensitivity of 81.9% and a specificity of 71.9% in this referred sample. MINI KID diagnosis was well aligned with local expressions of depression-like problems. CONCLUSION: The CES-DC demonstrates good psychometric properties for clinical screening and evaluation in Rwanda, and should be considered for use in this and other low-resource settings. Population samples are needed to determine a generalizable cut point in nonreferred samples.

Nothing can defeat combined hands (Abashize hamwe ntakibananira): protective processes and resilience in Rwandan children and families affected by HIV/AIDS.

In Rwanda, the dual vectors of HIV and legacy of the 1994 genocide have had devastating consequences for children and families. In this and other low-resource settings, extreme poverty, poor access to services, family conflict, and other adversities put children and families affected by HIV/AIDS at increased risk of mental health problems. However, even in the face of tremendous hardship, many children and families demonstrate better than expected outcomes. To design interventions that harness these natural sources of resilience, greater knowledge of local protective processes is needed. This study used free listing exercises (N = 68) and key informant interviews (N = 58) with adults and children (ages 10-17) to investigate strengths and sources of resilience in Rwandan children and families at risk for psychosocial difficulties due to HIV/AIDS. Clinician key informants (N = 10) were also interviewed. Five forms of protective resources emerged through this research: perseverance (kwihangana); self-esteem/self-confidence (kwigirira ikizere); family unity/trust (kwizerana); good parenting (kurera neza) and collective/communal support (ubufasha abaturage batanga). Operating within individual, family, and collective/community systems, these resources support children at multiple ecological levels. Study evidence suggests that these protective processes provide "leverage points" for strengths-based interventions designed to increase resilient outcomes and prevent mental health problems. This information on culturally-appropriate practices for building resilience, along with input from local community advisory boards and the government, has informed the development of a Family Strengthening Intervention, which has broad applications to many forms of adversity and trauma.

Using Mixed-Methods Research to Adapt and Evaluate a Family Strengthening Intervention in Rwanda.

INTRODUCTION: Research in several international settings indicates that children and adolescents affected by HIV and other compounded adversities are at increased risk for a range of mental health problems including depression, anxiety, and social withdrawal. More intervention research is needed to develop valid measurement and intervention tools to address child mental health in such settings. OBJECTIVE: This article presents a collaborative mixed-methods approach to designing and evaluating a mental health intervention to assist families facing multiple adversities in Rwanda. METHODS: Qualitative methods were used to gain knowledge of culturally-relevant mental health problems in children and adolescents, individual, family and community resources, and contextual dynamics among HIV-affected families. This data was used to guide the selection and adaptation of mental health measures to assess intervention outcomes. Measures were subjected to a quantitative validation exercise. Qualitative data and community advisory board input also informed the selection and adaptation of a family-based preventive intervention to reduce the risk for mental health problems among children in families affected by HIV.. Community-based participatory methods were used to ensure that the intervention targeted relevant problems manifest in Rwandan children and families and built on local strengths. RESULTS: Qualitative data on culturally-appropriate practices for building resilience in vulnerable families has enriched the development of a Family-Strengthening Intervention (FSI). Input from community partners has also contributed to creating a feasible and culturally-relevant intervention. Mental health measures demonstrate strong performance in this population. CONCLUSION: The mixed-methods model discussed represents a refined, multi-phase protocol for incorporating qualitative data and community input in the development and evaluation of feasible, culturally-sound quantitative assessments and intervention models. The mixed-methods approach may be applied to research in other parts of sub-Saharan Africa and beyond.