Clinical and psychosocial outcomes by sex among individuals prescribed buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX) for opioid use disorder.

BACKGROUND AND OBJECTIVES: Limited research has explored sex differences in opioid use disorder medication (MOUD) treatment outcomes. The purpose of this study was to examine MOUD initiation onto buprenorphine-naloxone (BUP-NX) versus extended-release naltrexone (XR-NTX) by sex, and sex differences in clinical and psychosocial outcomes. METHODS: Using data from a 24-week open-label comparative effectiveness trial of BUP-NX or XR-NTX, this study examined MOUD initiation (i.e., receiving a minimum one XR-NTX injection or first BUP-NX dose) and 24-week self-report outcomes. We used regression models to estimate the probability of MOUD initiation failure among the intent-to-treat sample (N = 570), and the main and interaction effects of sex on outcomes of interest among the subsample of participants who successfully initiated MOUD (n = 474). RESULTS: In the intent-to-treat sample, the odds of treatment initiation failure were not significantly different by sex. In the subsample of successful MOUD initiates, the effect of treatment on employment at week 24 was significantly moderated by sex (p = .003); odds of employment were not significantly different among males by MOUD type; females randomized to XR-NTX versus BUP-NX had 4.63 times greater odds of employment (p < .001). Males had significantly lower odds of past 30-day exchanging sex for drugs versus females (adjusted odds ratios [aOR] = 0.10, p = .004), controlling for treatment and baseline outcomes. DISCUSSION AND CONCLUSIONS: Further research should explore how to integrate employment support into OUD treatment to improve patient outcomes, particularly among women. SCIENTIFIC SIGNIFICANCE: The current study addressed gaps in the literature by examining sex differences in MOUD initiation and diverse treatment outcomes in a large, national sample.

Prescribed and Penalized: The Detrimental Impact of Mandated Reporting for Prenatal Utilization of Medication for Opioid Use Disorder.

OBJECTIVES: Some states, including Massachusetts, require automatic filing of child abuse and neglect for substance-exposed newborns, including infants exposed in-utero to clinician-prescribed medications to treat opioid use disorder (MOUD). The aim of this article is to explore effects of these mandated reporting policies on pregnant and postpartum people receiving MOUD. METHODS: We used modified grounded research theory, literature findings, and constant comparative methods to extract, analyze and contextualize perinatal experiences with child protection systems (CPS) and explore the impact of the Massachusetts mandated reporting policy on healthcare experiences and OUD treatment decisions. We drew from 26 semi-structured interviews originally conducted within a parent study of perinatal MOUD use in pregnancy and the postpartum period. RESULTS: Three themes unique to CPS reporting policies and involvement emerged. First, mothers who received MOUD during pregnancy identified mandated reporting for prenatally prescribed medication utilization as unjust and stigmatizing. Second, the stress caused by an impending CPS filing at delivery and the realities of CPS surveillance and involvement after filing were both perceived as harmful to family health and wellbeing. Finally, pregnant and postpartum individuals with OUD felt pressure to make medical decisions in a complex environment in which medical recommendations and the requirements of CPS agencies often compete. CONCLUSIONS FOR PRACTICE: Uncoupling of OUD treatment decisions in the perinatal period from mandated CPS reporting at time of delivery is essential. The primary focus for families affected by OUD must shift from surveillance and stigma to evidence-based treatment and access to supportive services and resources.

What is already known on this subject? Child protection systems (CPS) reporting is associated with barriers to prenatal care and family resources and services. Some state policies in the United States mandate reporting to CPS for prenatal substance exposure, including prescribed medications for opioid use disorder.What this study adds? This study centers the experiences of pregnant and postpartum people with opioid use disorder with mandated reporting policies for prenatal substance exposure, describes the harms to families associated with these policies, and makes recommendations for policy change. Findings emphasize the need to uncouple medical decisions from CPS reporting and involvement.

Measuring affiliation in group therapy for substance use disorders in the Women's Recovery Group study: Does it matter whether the group is all-women or mixed-gender?

BACKGROUND AND OBJECTIVES: A Stage II, two-site randomized clinical trial compared the manualized, single-gender Women's Recovery Group (WRG) to mixed-gender group therapy (Group Drug Counseling; GDC) and demonstrated efficacy. Enhanced affiliation and support in the WRG is a hypothesized mechanism of efficacy. This study sought to extend results of the previous small Stage I trial that showed the rate of supportive affiliative statements occurred more frequently in WRG than GDC. METHODS: Participants (N = 158; 100 women, 58 men) were 18 years or older, substance dependent, and had used substances within the past 60 days. Women were randomized to WRG (n = 52) or GDC (n = 48). Group therapy videos were coded by two independent raters; Rater 1 coded 20% of videos (n = 74); Rater 2 coded 25% of videos coded by Rater 1 (n = 19). RESULTS: The number of affiliative statements made in WRG was 66% higher than in GDC. Three of eight affiliative statement categories occurred more frequently in WRG than GDC: supportive, shared experience, and strategy statements. DISCUSSION AND CONCLUSIONS: This larger Stage II trial provided a greater number of group therapy tapes available for analysis. Results extended our previous findings, demonstrating both greater frequency of all affiliative statements, as well as specific categories of statements, made in single-gender WRG than mixed-gender GDC. SCIENTIFIC SIGNIFICANCE: Greater frequency of affiliative statements among group members may be one mechanism of enhanced support and efficacy in women-only WRG compared with standard mixed-gender group therapy for substance use disorders. (Am J Addict 2016;25:573-580).

Mutual Mistrust: The Multilayered Experiences at the Intersection of Healthcare and Early Parenting Among Mothers With Opioid Use Disorder.

OBJECTIVE: The aim of the study is to explore the early parenting experiences among a cohort of postpartum individuals with opioid use disorder (OUD) both during and after the delivery hospitalization to identify areas of intervention to strengthen bonding and attachment. METHODS: Semistructured qualitative interviews with recently pregnant people with OUD assessed parenting needs, supports, and goals in the context of the demands of addiction treatment and early motherhood. Probes explored the relationship between early parenting experiences, addiction, and recovery, as well as enabling factors and barriers to mother-infant bonding. Interviews were completed between 2019 to 2020. A constant comparative methods approach was used for codebook development and analysis. RESULTS: Twenty-six women completed interviews a mean of 10.1 months postpartum. Twenty-four women were receiving methadone or buprenorphine treatment at delivery for OUD. Four interrelated themes emerged. Women experienced the following: (1) increased surveillance from healthcare workers who doubted their parenting ability; (2) a desire for a "normal" early parenting experience that was not disrupted by increased medical monitoring and surveillance; (3) complex and intersecting identities of being both a mother and a person in recovery; and (4) the importance of support from and advocacy by clinicians and peers to developing maternal confidence and connection. CONCLUSIONS: Interventions are needed to improve the early parenting experiences of opioid-exposed mother-infant dyads, to address the mutual mistrust between health care providers and parents, and to provide additional supports to families. Promotion of positive attachment and parental self-efficacy should be prioritized over increased surveillance and scrutiny to sustain maternal recovery trajectories into early childhood and foster family well-being.

Behavioral health services in separate CHIP programs on the eve of parity.

The Children's Health Insurance Program (CHIP) plays a vital role in financing behavioral health services for low-income children. This study examines behavioral health benefit design and management in separate CHIP programs on the eve of federal requirements for behavioral health parity. Even before parity implementation, many state CHIP programs did not impose service limits or cost sharing for behavioral health benefits. However, a substantial share of states imposed limits or cost sharing that might hinder access to care. The majority of states use managed care to administer behavioral health benefits. It is important to monitor how states adapt their programs to comply with parity.

Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs.

OBJECTIVE: We sought to 1) identify models of integrated care that offer medical care and social services for children and families impacted by opioid use disorder (OUD) in the postpartum year; and 2) describe how each program was developed, designed, and sustained, and explore facilitators and barriers to implementation of a dyadic, two-generation approach to care. METHODS: In-depth semi-structured interviews (n = 23) were conducted with programs for women and children affected by OUD across North America. Using a phenomenologic approach, key program components and themes were identified. Following thematic saturation, these results were triangulated with experts in program implementation and with a subset of key informants to ensure data integrity. RESULTS: Five distinct types of programs were identified that varied in the degree of medical and behavioral care for families. Three themes emerged unique to the provision of dyadic care: 1) families require supportive, frequent visits with a range of providers, but constraints around billable services limit care integration across the perinatal continuum; 2) individual program champions are critical, but degree and reach of interdisciplinary care is limited by siloed systems for medical and behavioral care; and 3) addressing dual, sometimes competing, responsibilities for both parental and infant health following recurrence of parental substance use presents unique challenges. CONCLUSIONS: The key components of dyadic care models for families impacted by OUD included prioritizing care coordination, removing barriers to integrating medical and behavioral services, and ensuring the safety of children in homes with ongoing parental substance use while maintaining parental trust.

The relationship between perceived stress and depression in substance use disorder treatment.

BACKGROUND: Depression is highly prevalent among individuals with substance use disorders (SUDs), especially women, and has been noted to improve during SUD treatment. Perceived stress is independently related to severity of depression and substance use disorders (SUDs) as well as recurrence of symptoms and relapse following treatment. The aim of this study was to investigate among adults enrolled in SUD treatment whether levels of perceived stress and substance use over the course of treatment were related to reduction in depression. METHODS: This is a secondary analysis of data from the Women's Recovery Group Study. Women (n = 100) were randomized to either single- or mixed-gender group therapy and men (n = 58) received mixed-gender group therapy. Measures of substance use, perceived stress and depressive symptoms were collected for 6 months following treatment completion. In this study, we used lagged mixed models to investigate whether levels of substance use and perceived stress at each time point were associated with changes in depression at the subsequent time point. RESULTS: Results indicated that depressive symptoms significantly improved over time. Both substance use and perceived stress were associated with subsequent depressive symptoms. Importantly, stress was associated with symptoms when controlling for substance use, suggesting that changes in depressive symptoms were not solely attributable to levels of substance use. CONCLUSIONS: These results suggest that both stress and substance use are associated with improvements in depressive symptoms in substance use disorder treatment. Although preliminary, these results provide further support for the importance of targeting stress reduction in people with substance use disorders.

Trajectory classes of opioid use among individuals in a randomized controlled trial comparing extended-release naltrexone and buprenorphine-naloxone.

OBJECTIVES: To advance our understanding of medication treatments for opioid use disorders (OUDs), identification of distinct subgroups and factors associated with differential treatment response is critical. We examined trajectories of opioid use for patients with OUD who were randomized to (but not in all cases inducted onto) buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and identified characteristics associated with each trajectory. METHODS: Growth mixture models (GMMs) were run to identify distinct trajectories of days of opioid use among a subsample of 535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of BUP-NX (n = 281) or XR-NTX (n = 254). RESULTS: Four distinct opioid use trajectory classes were identified for BUP-NX (near abstinent/no use (59%); low use (13.2%); low use, increasing over time (15%); and moderate use, increasing over time (12.8%)). Three distinct opioid use trajectory classes were found for XR-NTX (near abstinent/no use (59.1%); low use (14.6%); and moderate use, increasing over time (26.4%)). Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits. Within BUP-NX, the low use class had a greater proportion of individuals with a previous successful treatment history compared with other classes. Within XR-NTX, the moderate use, increasing over time class had the highest proportion of Hispanic participants compared with other classes. CONCLUSIONS: Findings highlight the significant heterogeneity of opioid use during a RCT of BUP-NX and XR-NTX and factors associated with opioid use patterns including medical management visits and history of treatment success.

Substance abuse treatment entry, retention, and outcome in women: a review of the literature.

This paper reviews the literature examining characteristics associated with treatment outcome in women with substance use disorders. A search of the English language literature from 1975 to 2005 using Medline and PsycInfo databases found 280 relevant articles. Ninety percent of the studies investigating gender differences in substance abuse treatment outcomes were published since 1990, and of those, over 40% were published since the year 2000. Only 11.8% of these studies were randomized clinical trials. A convergence of evidence suggests that women with substance use disorders are less likely, over the lifetime, to enter treatment compared to their male counterparts. Once in treatment, however, gender is not a significant predictor of treatment retention, completion, or outcome. Gender-specific predictors of outcome do exist, however, and individual characteristics and treatment approaches can differentially affect outcomes by gender. While women-only treatment is not necessarily more effective than mixed-gender treatment, some greater effectiveness has been demonstrated by treatments that address problems more common to substance-abusing women or that are designed for specific subgroups of this population. There is a need to develop and test effective treatments for specific subgroups such as older women with substance use disorders, as well as those with co-occurring substance use and psychiatric disorders such as eating disorders. Future research on effectiveness and cost-effectiveness of gender-specific versus standard treatments, as well as identification of the characteristics of women and men who can benefit from mixed-gender versus single-gender treatments, would advance the field.

Understanding HIV Risk Behavior among Tuberculosis Patients with Alcohol Use Disorders in Tomsk, Russian Federation.

Russian Federation's (RF) HIV epidemic is the fastest growing of any country. This study explores factors associated with high HIV risk behavior in tuberculosis (TB) patients with alcohol use disorders in Tomsk, RF. This analysis was nested within the Integrated Management of Physician-delivered Alcohol Care for TB Patients (IMPACT, trial number NCT00675961) randomized controlled study of integrating alcohol treatment into TB treatment in Tomsk. Demographics, HIV risk behavior (defined as participant report of high-risk intravenous drug use and/or multiple sexual partners with inconsistent condom use in the last six months), clinical data, alcohol use, depression and psychosocial factors were collected from 196 participants (161 male and 35 female) at baseline. Forty-six participants (23.5%) endorsed HIV risk behavior at baseline. Incarceration history(Odds Ratio (OR)3.93, 95% confidence interval (CI) 1.95, 7.95), age under 41 (OR:2.97, CI:1.46, 6.04), drug addiction(OR: 3.60 CI:1.10, 11.77), history of a sexually transmitted disease(STD)(OR 2.00 CI:1.02, 3.90), low social capital (OR:2.81 CI:0.99, 8.03) and heavier alcohol use (OR:2.56 CI: 1.02, 6.46) were significantly more likely to be associated with HIV risk behavior at baseline. In adjusted analysis, age under 41(OR: 4.93, CI: 2.10, 11.58), incarceration history(OR: 3.56 CI:1.55, 8.17) and STD history (OR: 3.48, CI: 1.5, 8.10) continued to be significantly associated with HIV risk behavior. Understanding HIV transmission dynamics in Russia remains an urgent priority to inform strategies to address the epidemic. Larger studies addressing sex differences in risks and barriers to protective behavior are needed.

Gender-based Outcomes and Acceptability of a Computer-assisted Psychosocial Intervention for Substance Use Disorders.

BACKGROUND: Digital technologies show promise for increasing treatment accessibility and improving quality of care, but little is known about gender differences. This secondary analysis uses data from a multi-site effectiveness trial of a computer-assisted behavioral intervention, conducted within NIDA's National Drug Abuse Clinical Trials Network, to explore gender differences in intervention acceptability and treatment outcomes. METHODS: Men (n=314) and women (n=192) were randomly assigned to 12-weeks of treatment-as-usual (TAU) or modified TAU+Therapeutic Education System (TES), whereby TES substituted for 2hours of TAU per week. TES is composed of 62 Web-delivered, multimedia modules, covering skills for achieving and maintaining abstinence plus prize-based incentives contingent on abstinence and treatment adherence. Outcomes were: (1) abstinence from drugs and heavy drinking in the last 4weeks of treatment, (2) retention, (3) social functioning, and (4) drug and alcohol craving. Acceptability was the mean score across five indicators (i.e., interesting, useful, novel, easy to understand, and satisfaction). RESULTS: Gender did not moderate the effect of treatment on any outcome. Women reported higher acceptability scores at week 4 (p=.02), but no gender differences were detected at weeks 8 or 12. Acceptability was positively associated with abstinence, but only among women (p=.01). CONCLUSIONS: Findings suggest that men and women derive similar benefits from participating in a computer-assisted intervention, a promising outcome as technology-based treatments expand. Acceptability was associated with abstinence outcomes among women. Future research should explore characteristics of women who report less satisfaction with this modality of treatment and ways to improve overall acceptability.

Remission, residual symptoms, and nonresponse in the usual treatment of major depression in managed clinical practice.

BACKGROUND: Although published guidelines recommend the continuation of treatment for depression until full remission of symptoms and restoration of functioning, little is known about how often remission is achieved in usual practice and the precipitants of treatment termination when treatment outcome has not been optimal. METHOD: A naturalistic study design examined 1859 patients receiving treatment for DSM-III-R major depression between 1995 and 1997 in the national provider network of a managed behavioral health organization (MBHO). Symptom and impairment ratings by clinicians were used to group patients into full remission, partial remission, and no response. Claims data were used to characterize treatment and identify comorbid medical conditions. RESULTS: According to clinician ratings, approximately 27% to 39% of patients achieved full remission. Medical and substance use comorbidity and hospital admission were more common in those with a partial response to treatment. Only half of patients without a treatment response received a trial of medication during their treatment. Patient choice was the most common reason for termination of treatment, although nearly 40% of clinicians concurred with patients' decisions even when symptoms had not improved. CONCLUSION: Although rates of full remission were comparable to those in clinical trials of antidepressants, results suggest that clinicians may fail to recommend continuation and maintenance treatment consistent with best practice guidelines and that unsuccessful treatment often does not include antidepressant medication.

Substance use and perceived symptom improvement among patients with bipolar disorder and substance dependence.

BACKGROUND: Bipolar disorder (BPD) is the Axis I disorder with the highest risk for coexisting substance use disorder. One explanation for this phenomenon is the 'self-medication hypothesis', which states that some patients experience improvement in psychiatric symptoms as a result of substance use. We thus investigated reasons for substance use and perceived substance-induced improvement in BPD symptoms among patients with current BPD and substance dependence. METHODS: A total of 45 patients received six monthly assessments; 21 also received integrated group therapy (IGT), focusing simultaneously on BPD and substance dependence, while 24 did not receive IGT. Patients reported at intake their current reasons for initiating substance use (including BPD symptoms) and the effects of substance use on those symptoms. RESULTS: Nearly all patients initiated substance use because of at least one BPD symptom, especially depression (77.8%) and racing thoughts (57.8%); most (66.7%) reported improvement in at least one BPD symptom as a result of substance use. Among patients reporting substance-induced improvement in BPD symptoms, those receiving IGT reported fewer days of drug use over the 6-month study period than those not receiving IGT; this difference was not significant among patients without substance-induced improvement in BPD symptoms. LIMITATIONS: The study is limited by its small sample size and by the potential inaccuracy of self-reports regarding the effects of substance use on mood. CONCLUSIONS: Substance dependent patients who report that substance use improves their BPD symptoms may benefit from treatment that focuses simultaneously on both disorders.

Epidemiology of substance use disorders in women.

Significant gender differences exist in the prevalence of substance use disorders in the United States. There is a trend among boys and girls aged 12 to 17 years toward comparable rates of use and initiation for alcohol, cocaine, heroin, and tobacco. If this trend continues, over time there may be a narrowing of the male-to-female prevalence ratios of substance abuse in the older age groups. This possibility is particularly disturbing because women have a heightened vulnerability to medical, physical, mental, and social consequences of substance use. Women also carry additional unique risks during pregnancy because of the effect on neonates. In addition, they have certain gender-specific cancer risks. Given this and the declining age of initiation of substance use in women, prevention and treatment efforts especially geared toward women (eg, education of all medical and paramedical staff, screening in primary care clinics, detection of drug use early in pregnancy or before conception, brief interventions and treatment programs that integrate women's needs) are exceedingly important to stop and ultimately reverse this growing trend.

Beyond drug use: a systematic consideration of other outcomes in evaluations of treatments for substance use disorders.

Across the addictions field, the primary outcome in treatment research has been reduction in drug consumption. A comprehensive view of the impact of substance use disorders on human functioning suggests that effective treatments should address the many consequences and features of addiction beyond drug use, a recommendation forwarded by multiple expert panels and review papers. Despite recurring proposals, and a compelling general rationale for moving beyond drug use as the sole standard for evaluating addiction treatment, the field has yet to adopt any core set of 'other' measures that are routinely incorporated into treatment research. Among the many reasons for the limited impact of previous proposals has been the absence of a clear set of guidelines for selecting candidate outcomes. This paper is the result of the deliberations of a panel of substance abuse treatment and research experts convened by the National Institute on Drug Abuse to discuss appropriate outcome measures for clinical trials of substance abuse treatments. This paper provides an overview of previous recommendations and outlines specific guidelines for consideration of candidate outcomes. A list of outcomes meeting those guidelines is described and illustrated in detail with two outcomes: craving and quality of life. The paper concludes with specific recommendations for moving beyond the outcome listing offered in this paper to promote the programmatic incorporation of these outcomes into treatment research.

Implementing evidence-based alcohol interventions in a resource-limited setting: novel delivery strategies in Tomsk, Russia.

Effective implementation of evidence-based interventions in "real-world" settings can be challenging. Interventions based on externally valid trial findings can be even more difficult to apply in resource-limited settings, given marked differences-in provider experience, patient population, and health systems-between those settings and the typical clinical trial environment. Under the auspices of the Integrated Management of Physician-Delivered Alcohol Care for Tuberculosis Patients (IMPACT) study, a randomized, controlled effectiveness trial, and as an integrated component of tuberculosis treatment in Tomsk, Russia, we adapted two proven alcohol interventions to the delivery of care to 200 patients with alcohol use disorders. Tuberculosis providers performed screening for alcohol use disorders and also delivered naltrexone (with medical management) or a brief counseling intervention either independently or in combination as a seamless part of routine care. We report the innovations and challenges to intervention design, training, and delivery of both pharmacologic and behavioral alcohol interventions within programmatic tuberculosis treatment services. We also discuss the implications of these lessons learned within the context of meeting the challenge of providing evidence-based care in resource-limited settings.

Integrated employee assistance program/managed behavioral health plan utilization by persons with substance use disorders.

New federal parity and health reform legislation, promising increased behavioral health care access and a focus on prevention, has heightened interest in employee assistance programs (EAPs). This study investigated service utilization by persons with a primary substance use disorder (SUD) diagnosis in a managed behavioral health care (MBHC) organization's integrated EAP/MBHC product (N = 1,158). In 2004, 25.0% of clients used the EAP first for new treatment episodes. After initial EAP utilization, 44.4% received no additional formal services through the plan, and 40.4% received regular outpatient services. Overall, outpatient care, intensive outpatient/day treatment, and inpatient/residential detoxification were most common. About half of the clients had co-occurring psychiatric diagnoses. Mental health service utilization was extensive. Findings suggest that for service users with primary SUD diagnoses in an integrated EAP/MBHC product, the EAP benefit plays a key role at the front end of treatment and is often only one component of treatment episodes.

What is "women-focused" treatment for substance use disorders?

Over the past three decades research has highlighted gender differences in substance use disorders and substance abuse treatment participation. Programs devoted to addressing women's treatment needs, broadly encompassed in the term "women-focused treatment," have multiplied. This column examines the rationale for women-focused treatment and describes some of its components. The authors cite the need to evaluate women-focused treatment by developing validated measures of the processes embodied in such treatment and by conducting empirically sound research on clinical outcomes, treatment effectiveness, cost-effectiveness, and the optimal means of providing services to women with substance use disorders.