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Abstract: Introduction: Given the continued rise in opioid exposed pregnancies and overdose during the postnatal period, it is critical to identify risk characteristics among this population to enable clinicians to better tailor interventions. This exploratory study sought to develop a deeper understanding of overdose risk characteristics among pregnant people with opioid use disorder and which characteristics may contribute to differing risk profiles. Methods: Design and participants. This exploratory secondary analysis utilized baseline data from a large-scale national multi-site randomized controlled trial that compared two buprenorphine formulations among treatment seeking pregnant individuals with opioid use disorder. Assessments: For risk group identification, the Personal Opioid-Overdose Risk Survey was used. Trauma history experience was assessed using the Trauma History Screen and substance use history was captured using the DSM-5 Checklist and Treatment Services Review V6. Analyses: Latent class analysis identified unique subgroups of participants based on overdose risk factors. Latent class group membership was associated with trauma history and substance use characteristics using logistic and stepwise logistic regression. Results: Three distinct classes of overdose risk emerged: the tolerance and polysubstance/alcohol use (HIGH-ALC) class (n = 14, 10 %), synthetic opioid and polysubstance use (LOW-ALC/FENT) class (n = 65, 46.4 %), and the low risk (LOW-RISK) class (n = 61, 43.6 %). The HIGH-ALC class reported the most (non-opioid) substance use in the last 12 months with 6 times higher odds of marijuana use (95 % CI, 1.01-35.67) and 17.48 times higher odds of cocaine use (95 % CI, 3.45-88.48) compared to the LOW-RISK class. The LOW-ALC/FENT class (n = 65, 46.4 %) had the highest reports of childhood physical abuse, greater odds of experiencing intimate partner violence regarding recovery (OR = 4.82, 95 % CI = 1.90-12.26), and greater odds of a threat to safe living (OR = 3.35, 95 % CI = 0.72-15.66). The LOW-RISK class (n = 61, 43.6 %) had the lowest reports of polysubstance use in the last 12 months and the least reports of both childhood sexual trauma and adulthood sexual trauma. Conclusions: Through better understanding distinct patient overdose risk profiles, healthcare providers can deliver more targeted prevention interventions to address individual needs and improve maternal outcomes. Related protocols: CTN-0080

Abstract:

Trauma screening is recommended for pregnant persons with opioid use disorder (OUD), but there is limited literature on screening results from buprenorphine treatment. This study’s objectives were to 1) describe the types, and severity, of traumatic events reported and 2) evaluate the associations between trauma and health-related quality of life (HRQoL).

Baseline data from an ongoing trial were analyzed (CTN-0080). Participants were 155 pregnant persons with OUD receiving, or enrolling in, buprenorphine treatment at one of 13 sites. The experience, and relative severity, of 14 high magnitude stressors were assessed with the trauma history screen. The Patient-Reported Outcomes Measurement Information System-29+2 was used to assess 8 HRQoL domains.

Traumatic stressors were reported by 91% of the sample (n = 155), with 54.8% reporting a lifetime persisting posttraumatic distress (PPD) event and 29.7% reporting a childhood PPD event. The most prevalent lifetime PPD event was sudden death of a close family/friend (25.8%); physical abuse was the most prevalent childhood PPD event (10.3%). Participants with lifetime PPD, relative to no PPD, reported significantly greater pain interference (P = 0.02). Participants with childhood PPD, relative to no PPD, had significantly worse HRQoL overall (P = 0.01), and worse pain intensity (P = 0.002), anxiety (P = 0.003), depression (P = 0.007), fatigue (P = 0.002), and pain interference (P < 0.001).

Conclusions: A majority of pregnant persons enrolled/enrolling in buprenorphine treatment reported persisting posttraumatic distress with sudden death of close family/friend being the most prevalent originating event; clinicians should consider the impact that the opioid-overdose epidemic may be having in increasing trauma exposure in patients with OUD.

Related protocols: CTN-0080

Abstract:

Substance use is a public crisis in the U.S. Substance use can be understood as a series of events in the life course, from initiation to mortality. Social Determinants of Health (SDoH) have increasingly been recognized as essential contributors to individuals’ health. This scoping review aims to examine available evidence of SDoH impact on the life course of substance use disorder (SUD).

Substance use is a public crisis in the U.S. Substance use can be understood as a series of events in the life course, from initiation to mortality. Social Determinants of Health (SDoH) have increasingly been recognized as essential contributors to individuals’ health. This scoping review, supported by the NIDA CTN Greater Southern California Node, aims to examine available evidence of SDoH impact on the life course of substance use disorder (SUD).

Among the 50 studies identified, ten revealed parental monitoring/support and early childhood education as protective factors, while negative peer influences and neighborhood instability were risk factors of substance use initiation. Nineteen articles reported factors associated with escalation in substance use, including unemployment, neighborhood vulnerability, negative peer influence, violence/trauma, and criminal justice system (CJS) involvement. Ten articles suggested that employment, social support, urban living, and low-barrier medication treatment facilitated treatment participation, while stigma and CJS involvement had negative impact on treatment trajectory. Social support and employment could foster progress in recovery and CJS involvement and unstable housing deterred recovery. Four studies suggested that unemployment, unstable housing, CJS involvement, and lack of social support were associated with overdose and mortality.

Conclusions: This review underscores the influence of social networks and early life experiences on the life course of SUD. Future SDoH research should investigate overdose and mortality and the impact of broader upstream SDoH on SUD. Interventions addressing these social factors are needed to mitigate their detrimental effects on the trajectories of SUD over the life course.

Abstract:

The learning health care system (LHS) envisions the integration of research and care delivery in a manner that rapidly generates and adopts new evidence to improve health care quality and patient experience. Efforts to operationalize and evaluate the LHS have identified facilitation as a core construct when describing the implementation support needed to achieve the desired outcomes. There is a rich literature documenting the effectiveness of facilitation as a strategy for implementing evidence-based innovations that improve the quality of health care. Facilitation is enabled by practice facilitators (PFs) who activate implementation of changes that improve care quality. They help others navigate complex change processes when implementing new evidence into practice by assessing and responding to unique characteristics of both the interventions and the context within which they are being implemented. For the evaluation of LHSs, one proposed measure of the presence of adequate implementation support is a count of PF hours provided for care delivery initiatives. As a result, there is a growing interest in understanding how an LHS might prepare and support individuals to be effective in this role with the goal of improving care quality. This commentary piece examines five critical supports needed for a PF program within an LHD and offers suggested practical actions based on the authors’ experience that an LHS can take to enhance the effectiveness of facilitation as an implementation strategy to improve care quality and outcomes.

Abstract:

Benzodiazepines and opioids are used alone or in conjunction in certain care settings, but each have the potential for misuse. This longitudinal observational study, developed with CTN support through the Ohio Valley Node “base” award, evaluated substance use and mental health outcomes associated with providing opioids with or without benzodiazepine to treat traumatic injury in the emergency department (ED) setting.

Researchers analyzed a limited dataset obtained through the IBM Watson Health Explorys. Matched cohorts were defined for: 1) patients treated with opioids during the ED encounter (ED-Opioid) vs. neither opioid or benzodiazepine treatment (No medication) (n = 5372); 2) patients treated with opioids and benzodiazepines during the ED encounter (ED-Opioid+Benzodiazepines) vs. No Medication (n = 2454); and 3) ED-Opioid+Benzodiazepines vs. ED-Opioid (n = 2454). Patients consisted of adults with an emergency department encounter in the MetroHealth System (Cleveland, Ohio) with a chief complaint of traumatic injury and medical records for five years following the encounter. Control patients for each cohort were matched to the exposure patients on demographics, body mass index, and residential zip code median income. Outcomes were five-year incidence rates for alcohol, substance use, depression, and anxiety-related diagnoses.

Results indicated that, although receiving opioids during the ED visit predicted a relatively lower likelihood of subsequent substance use and mental health diagnoses, the brief co-use of benzodiazepines was strongly associated with poorer outcomes.

Conclusions: Even brief exposure to co-prescribed opioids and benzodiazepines during emergency traumatic injury care may be associated with negative substance use and mental health consequences in the years following the event.

Abstract:

Black women are at heightened risk for trauma exposure, post-traumatic stress disorder (PTSD), and substance use disorders (SUDs) compared to white women and the general population. However, disparities in treatment engagement and retention persist, particularly for Black women with co-occurring PTSD and SUD. Although therapeutic alliance is an important predictor and mediator of treatment retention and outcomes, we know little about predictors of alliance and the mediating role of alliance for PTSD+SUD outcomes among Black women.

This study used data previously collected for the National Drug Abuse Treatment Clinical Trials Network (CTN) Women and Trauma Study (CTN-0015), which compared Seeking Safety (a cognitive-behavioral intervention for PTSD+SUD) to Women’s Health Education (control). It includes 88 Black/African American women from both arms of the original trial. Measures included the Helping Alliance Questionnaire, Addiction Severity Index-Lite, and Clinician Administered PTSD Scale. Women in the intervention arm also completed the Seeking Safety Feedback Questionnaire.

Stepwise, hierarchical linear regressions indicted that years of education and previous alcohol/drug treatment attempts significantly predicted early alliance in the second week of therapy, but not late alliance in the last week of therapy. Greater education and more treatment attempts were associated with higher early alliance. Alliance did not mediate relationships between these significant predictors and treatment outcomes (e.g., attendance, post-treatment PTSD and SUD symptoms) or treatment feedback in the Seeking Safety group.

Conclusions: Education and prior treatment attempts predicted early alliance among Black/African American women in PTSD+SUD group treatment, and higher education level was associated with poorer Seeking Safety feedback topic ratings. Educational level and treatment history should be considered during alliance building in therapeutic interventions with Black women. Clinicians may consider the integration of pre-treatment alliance-building strategies with Black female patients who have lower levels of education. This study provides insight into the relative impact of several important factors that influence early alliance among Black women with co-occurring PTSD and SUD.

Related protocols: CTN-0015

Abstract:

The co-occurrence of substance use disorders (SUD) and trauma-exposure is a risk factor for suicidal thoughts and behaviors (STB). However, traditional methods of measurement for suicidal thoughts and behaviors are limited by an overreliance on dichotomous (i.e., yes or no) and averaged/summed scale score measurements. Further, among trauma-exposed individuals with SUD, it remains unclear which specific demographic factors, types of SUDs, and trauma sequelae (e.g., posttraumatic stress disorder [PTSD] symptom clusters) may be associated with elevated STB.

The present study utilized item response theory to (a) generate empirically derived STB severity scores and, (b) examine which demographic factors, SUD diagnoses, and DSM-IV PTSD symptom clusters are associated with suicidality in a trauma-exposed sample with SUDs.

Female trauma-exposed participants with SUDs (N=544) were recruited from community substance use treatment facilities in the NIDA Clinical Trials Network (CTN). Clinician-administered interviews assessed STB, SUDs, and PTSD symptoms.

Results indicated that the unidimensional item response theory (IRT) model used to estimate latent STB severity scores fit well, with strong local reliability and higher levels of latent STB severity. Regression predictors of elevated STB severity included younger age, opioid dependence, and higher PTSD reexperiencing symptoms.

Conclusions: Despite the critical importance of understanding, assessing, and identifying STB in trauma-exposed populations with SUDs, research methodologies that measure these variables are limited. This study used an innovative statistical analytic methodology to examine STB in a way that mirrors the weighting of various factors in suicide risk assessment. The findings highlight that trauma-exposed women with substance dependence who are younger, have opioid dependence, and/or have higher reexperiencing symptoms may warrant focused suicide risk assessment and management strategies. Clinicians are advised to screen for and target opioid use disorders and reexperiencing symptoms when addressing suicidal thoughts and behavior in trauma-exposed individuals with SUDs. Future work to elucidate the mechanisms through which these relationships operate would be beneficial.

Abstract:

Research studies suggest racial/ethnic differences in posttraumatic stress disorder (PTSD) diagnosis and symptom severity. Few studies to date, however, have examined the extent to which these findings are due to differences in measurement properties of existing PTSD scales. This study examined measurement equivalence across race/ethnicity in the Clinician-Administered PTSD Scale (CAPS) by testing for differential item functioning (DIF) in the item response theory (IRT) framework.

Participants were 506 trauma-exposed women (M=39.41 years), who participated in the NIDA Clinical Trials Network Women and Trauma study (CTN-0015). PTSD severity score estimates were improved upon as part of IRT estimation incorporating symptom “weights” (i.e., factor loadings) and group-specific DIF. Six symptoms from the CAPS showed DIF, with the majority of differences in measurement driven by White/African Americans and White/Latina differences, particularly for (a) avoidance of thoughts and (b) a sense of foreshortened future. Despite both racial/ethnic minority groups being slight (not significantly) more likely to receive a PTSD diagnosis, African Americans and Latinas had significantly lower PTSD severity scores than Whites as estimated under IRT with group-specific DIF. Examination of PTSD severity scores based on symptom counts revealed these differences were either dampened or entirely negated.

Conclusions: These findings suggest the importance of considering differences in symptom relevance across race/ethnicity and their impact on capturing symptom severity parallel to diagnostic criteria. Implications for clinical practice are discussed.

Related protocols: CTN-0015

Abstract:

Most of the work on understanding subthreshold PTSD has focused on inconsistencies in defining subthreshold PTSD and how those inconsistencies impact prevalence rates. The present study distinguishes between full and subthreshold PTSD using empirical categorization and assesses the circumstances under which empirical categorization is discordant with full and subthreshold PTSD diagnoses.

Using data from the NIDA Clinical Trials Network protocol “Women’s Treatment for Trauma and Substance Use Disorders” (CTN-0015), researched used a modernized adaptation of the Jacobson and Truax (1991) framework, assessing whether patients were above or below an empirical threshold on latent PTSD severity scores estimated under categorical confirmatory factor analysis; the empirical categorizations were then crossed with the diagnosis to form four diagnostic by empirical categorization groupings.

Compared to a reference group (full PTSD diagnosis and empirical categorization), patients who had a full PTSD diagnosis but a subthreshold empirical categorization had lower symptom endorsement rates on 15 PTSD symptoms, were more likely to be married, ethnic minorities with fewer lifetime traumas. Conversely, patients with a subthreshold PTSD diagnosis and a full PTSD empirical grouping looked similar to “Full/Fulls,” only differing on avoidance symptoms.

Conclusions: Although alternative definitions of subthreshold PTSD and coding of symptom endorsement, as well as use of DSM-IV symptoms (though reconciled against overlapping symptoms from DSM-5), may impact results, these results suggest that empirical categorization can be a useful supplement to diagnosis in distinguishing subthreshold PTSD from full PTSD, using a methodology that could provide a platform for melding dimensional and categorical nosology approaches in the DSM.

Related protocols: CTN-0015

Abstract:

The “Women and Trauma” Study (WTS) conducted in the National Drug Abuse Treatment Clinical Trials Network (CTN-0015) resulted in research publications, presentations, and a train-the-trainer workshop to support dissemination efforts for skills-based trauma treatment in substance use community treatment. Twelve years after its completion, this paper aims to examine whether and how the WTS contributed to knowledge in the field of trauma and addictions and inspired community treatment programs (CTPs) to train staff to identify and provide trauma-related services.

This article presents findings from two different analyses that explored longer-term study impacts on treatment and dissemination: (1) a post-study site survey covering 4 domains from 4/7 programs that participated in delivering the WTS to evaluate their perceptions of study impact on their treatment community; and (2) an analysis of citations of its publications to determine impact on the scientific community.

Surveys from responding sites indicated that participation in the study significantly increased their agencies” awareness of the need to take a focused approach to treating trauma issues in this population. Specifically, these sites increased their commitment to using skills-based trauma treatment with the study’s target population of female patients with SUD and trauma histories, as well as expanding it to other groups affected by trauma. Citation analysis revealed that according to the Web of Science, as of August 2019, the number of citations of 24 CTN-0015 articles, ranged from 1 to 135 (Mean = 20, SD = 33; Median = 6). Four of the most influential are discussed.

Conclusions: This article provides original information about the contributions of the WTS study, demonstrating how the study contributed to serving women with trauma in community substance use treatment.

Related protocols: CTN-0015

Abstract:

The aim of this research was to explore the association of abuse experiences (child sexual abuse and adult physical/sexual violence) to sexual relationship power among Black substance-abusing women. The study was a secondary analysis of baseline data collected from 124 Black women in 12 drug treatment programs across the United States who initially participated in an HIV risk reduction trial conducted within the NIDA Clinical Trials Network. The findings revealed that adult sexual abuse, but not childhood sexual or adult physical abuse, was associated with lower relationship control and decision-making dominance as measured by the Sexual Relationship Power Scale.

Conclusions: These findings suggest that a history of adult sexual abuse may disempower Black substance-abusing women from negotiating for safer sex. That argues for addressing a history of adult sexual abuse as a strategy for empowering women to advocate for their sexual health. Designing and implementing sexual risk reduction interventions that address adult sexual violence may enhance the relationship power of Black substance-abusing women and in turn may promote safer sex practices.

Related protocols: CTN-0019

Abstract:

While the detrimental effects of concurrent substance use disorders (SUDs) are now being well documented, very few studies have examined this comorbidity among women with posttraumatic stress disorder (PTSD). Data for these analyses were derived from the “Women and Trauma” study conducted within the NIDA Clinical Trials Network. Women with full or subthreshold PTSD and co-occurring cannabis use disorder (CUD) and cocaine use disorder (COD; N=99) were compared to their counterparts with co-occurring CUD only (N=26) and co-occurring COD only (N=161) on rates of trauma exposure, psychiatric disorders, psychosocial problems, and other substance use utilizing a set of multivariate logistic regressions. In models adjusted for age and race/ethnicity, women with PTSD and COD only were significantly older than their counterparts with CUD only and concurrent CUD+COD. Relative to those with CUD only, women with concurrent CUD+COD had higher odds of adult sexual assault. Relative to those with COD only, women with concurrent CUD+COD had higher odds of alcohol use disorder in the past 12 months. Finally, relative to those with CUD only, women with COD only had higher odds of ever being arrested/convicted and adult sexual assault.

Conclusions: The higher rates of adult sexual assault and alcohol use disorder among those with concurrent CUD+COD suggest the need for trauma-informed approaches that can response to the needs of this dually-diagnosed population. Moreover, the causal link between repeated traumatic stress exposure and polysubstance use requires further examination.

Related protocols: CTN-0015

Abstract:

Eating disorders (ED) and substance use disorders (SUD) commonly co-occur, especially in conjunction with posttraumatic stress disorder (PTSD), yet little is known about ED and ED symptoms in women presenting to addiction treatment programs. This study examined the association between ED symptoms and substance use frequency and severity in a sample of women with a DSM IV diagnosis of current SUD and PTSD enrolled in SUD treatment. Participants were 122 women from four substance abuse treatment sites who participated in a multi-site clinical trial through NIDA’s Clinical Trials Network (CTN). The Eating Disorder Examination-Questionnaire (EDE-Q), the Clinician Administered PTSD Scale (CAPS), and the Addiction Severity Index (ASI) were administered at baseline and correlational analyses were performed. Variables that significantly correlated with EDE-Q total and subscale scores were entered into a linear regression analysis. Results found that scores on the EDE-Q Global scale, as well as the Eating Concern, Weight Concern, and Shape Concern subscales of the EDE-Q were significantly associated with Caucasian race/ethnicity, past 30 day opiate use, higher ASI Psychiatric Subscale score, and lower ASI Employment Subscale score.

Conclusions: Women in recovery from SUD and PTSD reported concerns about weight, shape, and eating at a higher rate than in the general US population of women. The finding that past 30 day opiate use was associated with EDE scores may indicate that opiates also play a substantial role in disordered eating symptoms. Though exploratory, these findings suggest that there may be a relationship between addiction severity, use of certain drugs of abuse, and eating disorder symptoms, particularly those involving weight and shape concerns in women with comorbid PTSD and SUD. Comprehensive and integrated treatment approaches need to be developed to address this complex but common comorbidity.

Related protocols: CTN-0015, CTN-0015-A-1

Abstract:

Despite advances toward integration of care for women with co-occurring substance use disorder (SUD) and post-traumatic stress disorder (PTSD), low abstinence rates following SUD/PTSD treatment remain the norm. The utility of investigating distinct substance use trajectories is a critical innovation in the detection and refining of effective interventions for this clinical population. The present study reanalyzed data from the largest randomized clinical trial to date for co-occurring SUD and PTSD in women (National Drug Abuse Treatment Clinical Trials Network protocol CTN-0015, “Women’s Treatment for Trauma and Substance Use Disorders”). Randomized participants (n=353) received one of two interventions in addition to treatment as usual for SUD: 1) trauma-informed integrative treatment for PTSD/SUD (Seeking Safety); or 2) an active control psychoeducation course on women’s health (Women’s Health Education).

The present study utilized latent growth mixture models (LGMM) with multiple groups to estimate women’s substance use patterns during the 12-month follow-up period. Findings provided support for three different trajectories of substance use in the post-treatment year: 1) consistently low likelihood and use frequency; 2) consistently high likelihood and use frequency; and 3) high likelihood and moderate use frequency. Covariate analyses revealed improvement in PTSD severity was associated with membership in a specific substance use trajectory, although receiving trauma-informed treatment was not. Additionally, SUD severity, age, and after-care efforts were shown to be related to trajectory membership.

Conclusions: Findings highlight the necessity of accounting for heterogeneity in post-treatment substance use, relevance of trauma-informed care in SUD recovery, and benefits of incorporating methodologies like LGMM when evaluating SUD treatment outcomes. For women dually diagnosed with PTSD and SUD, the current study established the presence of several varied clinical presentations linked to substance use following treatment, each with potentially different needs, vulnerabilities, and strengths. Results of this study also point to opportunities for tailing interventions to the specific clinical presentation and potential impact of these choices on a woman’s trajectory of recovery.

Abstract:

Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and post-traumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on “superiority” designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment.

This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses as a case example one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (CTN). The paper concludes with implications of this secondary analytic approach to improve addiction researchers’ ability to identify best practices for community-based treatment of these disorders.

Conclusions: Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Given the continuing gap between research and practice, appropriately executed secondary analytic studies are an important step in addressing questions that have real-world value to community clinicians. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal consideration and care to the primary outcome analysis.