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Background: Opioid use disorder (OUD) during pregnancy is a leading contributor to peripartum morbidity and mortality, with overdose deaths rising significantly in recent years. Despite the identification of various factors associated with overdose events, including social, demographic, psychiatric, and neonatal outcomes, the relative contributions of these factors to peripartum overdose history (or lack thereof) remain unclear. Thus, this study aims to characterize factors associated with lifetime opioid-involved overdose events among currently pregnant individuals receiving buprenorphine (BUP) treatment for OUD.
Methods: Treatment-seeking pregnant individuals with an estimated gestational age of 6 to 30 weeks were enrolled in a large multisite randomized controlled trial evaluating 2 BUP formulations for OUD. Participant baseline demographic, substance use, and mental health data were collected using validated measures, and random forest modeling identified key factors associated with lifetime opioid overdose events.
Results: The 140 pregnant participants (Mage = 31.2 years, SD = 4.7; 87.1% White) reported an average of 8.7 years (SD = 5.8) of opioid use, with 92.1% endorsing lifetime prescription opioid use and 82.9% reporting heroin use. The average lifetime number of nonfatal opioid overdose events was 4.8 (SD = 12.1); an overdose was reported by 55% of the sample (n = 77). Random forest analysis (area under the receiver operating characteristic curve = 0.797) incorporating sociodemographic, substance use, and mental health characteristics found that the most important factors associated with lifetime overdose events were, in order, lifetime heroin use, trauma exposure, reliance on partners or parents for financial support, depressive symptoms, and lifetime cocaine use.
Conclusions: These findings underscore the critical need to address substance use, co-occurring mental health, and socioeconomic challenges that are associated with previous opioid overdose. Identifying and targeting key modifiable overdose risk factors can inform the development of tailored interventions to improve outcomes for this population.
Related protocols: CTN-0080
Introduction: Cigarette smoking rates among pregnant women with opioid use disorder (OUD), are significantly higher than those found in the general population.
Methods: We conducted a secondary analysis of baseline data from a multisite, randomized clinical trial comparing two different buprenorphine formulations on outcomes during pregnancy. Cigarette use and smoking cessation goals were evaluated with the Fagerström Test for Nicotine Dependence and the Thoughts About Abstinence (TAA) questionnaire respectively. Factors associated with differences in cigarette use and smoking cessation goals were compared.
Results: Among 156 participants, 85 (54.5 %) reported that they currently smoked cigarettes. Most participants had a desire to quit smoking (TAA score = 6), but they had low expectations of success (TAA score = 4) and a relatively high perceived difficulty (TAA score = 6.5) of quitting during pregnancy. Among participants who smoked, less than half (45.5 %) had a smoking cessation goal. Participants who had a smoking cessation goal were significantly more likely to have a stronger desire to quit and higher expectations of success in quitting than participants who did not have a goal.
Conclusions: Many pregnant women with OUD would like to quit or reduce smoking during pregnancy. A combination of pharmacologic and non-pharmacologic interventions to reduce or eliminate cigarette use should be incorporated into obstetric and substance use treatment clinical settings. Smoking cessation interventions should be aligned with patients’ goals and preferences.
Related protocols: CTN-0080
This is the primary outcomes article for CTN-0150.
Overdose is a leading cause of pregnancy-associated mortality in the US. Our personally-tailored opioid-overdose (OOD) and medication for opioid use disorder (MOUD) education intervention has been shown to significantly improve MOUD/OOD knowledge in out-of-treatment persons using illicit opioids. We evaluated the ability of the intervention modified for peripartum (pregnant or within one year postpartum) individuals, the personally-tailored OOD and MOUD education (TOME) intervention, to increase MOUD (primary) and OOD (key secondary) knowledge.
Methods: A six-site, two-arm, open-label, trial with 131 peripartum individuals receiving MOUD (methadone or buprenorphine) randomized to TOME, a 15-minute, computer-facilitated, individually-tailored intervention, or Control. TOME participants received education on MOUD and OOD questions they missed in a pre-test. Control participants received SAMHSA handouts on OOD and MOUD. All participants were scheduled for a 3-week post-test.
Results: Participants were enrolled in MOUD for an average of 15.6 months (SD=20.4) at baseline, with 30.5% enrolled in methadone and 69.5% enrolled in buprenorphine treatment. On the pre-test, participants answered 66.7% of the MOUD and 82.1% of the OOD questions correctly on average. Linear regressions indicated that participants’ MOUD (X2=33.96, p<0.001) and OOD (X2=45.78, p<0.001) knowledge increased significantly more in the TOME, relative to Control, group.
Conclusions: In a sample of peripartum patients enrolled in MOUD for a substantial length of time, TOME significantly increased MOUD and OOD knowledge. Taken together with past research, these findings suggest that there are gaps in MOUD and OOD knowledge in individuals with opioid use disorder that can be addressed with brief personally-tailored education.
Related protocols: CTN-0150
Objectives: Assessment and counseling are recommended for individuals with prenatal cannabis use. We examined characteristics that predict prenatal substance use assessment and counseling among individuals who screened positive for prenatal cannabis use in prenatal settings.
Methods: Electronic health record data from Kaiser Permanente Northern California’s Early Start perinatal substance use screening, assessment, and counseling program was used to identify individuals with =1 pregnancies positive for prenatal cannabis use. Outcomes included completion of a substance use assessment and among those assessed, attendance in Early Start counseling only or Addiction Medicine Recovery Services (AMRS) treatment. Predictors included demographics and past-year psychiatric and substance use disorder diagnoses evaluated with GEE multinomial logistic regression.
Results: The sample included 17,782 individuals with 20,398 pregnancies positive for cannabis use (1/2011-12/2021). Most pregnancies (80.3%) had an assessment. Individuals with Medicaid, anxiety, depression and tobacco use disorders, compared to those without, had higher odds and those with greater parity, older age (=35) and in later trimesters, had lower odds of assessment. Among 64% (n = 10,469) pregnancies needing intervention based on assessment, most (88%) attended Early Start counseling only or AMRS (with or without Early Start). Greater parity and later trimester assessment was associated with lower odds, while Medicaid was associated with higher odds of Early Start counseling. Nearly all diagnosed psychiatric and substance use disorders were associated with higher odds of AMRS treatment.
Conclusions: A comprehensive prenatal substance use program engaged most pregnant individuals with prenatal cannabis use in substance use assessment and counseling. Opportunities to improve care gaps remain.
Related protocols: CTN-0140
This brochure, intended for clinicians participating in the CTN-0013 clinical trial (MET to Improve Treatment Utilization and Outcome in Pregnant Substance Users), provides an overview of Motivational Enhancement Therapy (MET) and answers to questions participants might have about being involved in the research project.
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 (CTN-0051, X:BOT), 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.
Related protocols: CTN-0051
Brief cannabis screening followed by standardized assessment of symptoms may support diagnosis and treatment of cannabis use disorder (CUD). This study tested whether the probability of a medical provider diagnosing and treating CUD increased with the number of substance use disorder (SUD) symptoms documented in patients’ EHRs.
This observational study from the Health Systems Node (related to CTN-0113) used EHR and claims data from an integrated healthcare system. Adult patients were included who reported daily cannabis use and completed the Substance Use Symptom Checklist, a scaled measure of DSM-5 SUD symptoms (0-11), during routine care 3/1/2015-3/1/2021. Logistic regression estimated associations between SUD symptom counts and: 1) CUD diagnosis; 2) CUD treatment initiation; and 3) CUD treatment engagement, defined based on Healthcare Effectiveness Data and Information Set (HEDIS) ICD-codes and timelines. We tested moderation across age, gender, race, and ethnicity.
Patients (N=13,947) were predominantly middle-age, male, White, and non-Hispanic. Among patients reporting daily cannabis use without other drug use (N=12,568), the probability of CUD diagnosis, treatment initiation, and engagement increased with each 1-unit increase in Symptom Checklist score (p’s<0.001). However, probabilities of diagnosis, treatment, and engagement were low, even among those reporting =2 symptoms consistent with SUD: 14.0% diagnosed (95% CI: 11.7-21.6), 16.6% initiated treatment among diagnosed (11.7-21.6), and 24.3% engaged in treatment among initiated (15.8-32.7). Only gender moderated associations between Symptom Checklist and diagnosis (p=0.047) and treatment initiation (p=0.012). Findings were similar for patients reporting daily cannabis use with other drug use (N=1,379).
Conclusions: This study highlights the need to improve diagnosis and treatment of CUD in general medical settings. While the probability of provider-documented CUD diagnosis and treatment increased with patient-report of symptoms, most patients with severe CUD did not receive diagnosis or treatment. The probability of CUD diagnosis and treatment could be even lower in other settings without routine cannabis assessment. There were missed opportunities across all sociodemographic subgroups, but women with severe CUD may be particularly less likely to initiate treatment. Further research should identify optimal approaches for initiating and engaging patients in CUD treatment in medical settings.
Related protocols: CTN-0113
Pregnant individuals with substance use disorders face complex issues that may serve as barriers to treatment entry and retention. Several professional organizations have established recommendations on comprehensive, collaborative approaches to treatment to meet the needs of this population, but information on real-world application is lacking. Sites participating in the NIDA CTN-0080 “Medication treatment for Opioid use disorder in expectant Mothers (MOMs)”–a randomized clinical trial of extended release compared to sublingual buprenorphine among pregnant and postpartum individuals (PPI)–were selected, in part, because they have a collaborative approach to treating PPI with opioid use disorder (OUD). However, organizational differences among sites and how they implement expert recommendations for collaborative care could impact study outcomes.
Prior to study launch at each of the 13 MOMs sites, investigators used the Pregnancy and Addiction Services Assessment (PAASA) to collect information about organizational factors. Input from a team of addiction, perinatal, and economic evaluation experts guided the development of the PAASA. Investigators programmed the PAASA into a web-based data system and summarized the resultant site data using descriptive statistics.
Study sites represented four US census regions. Most sites were specialty obstetrics & gynecology (OB/GYN) programs providing OUD services (n = 9, 69.2 %), were affiliated with an academic institution (n = 11, 84.6 %), and prescribed buprenorphine in an ambulatory/outpatient setting (n = 11, 84.6 %); all sites offered access to naloxone. Sites reported that their population was primarily White, utilized public insurance, and faced numerous psychosocial barriers to treatment. Although all sites offered many services recommended by expert consensus groups, they varied in how they coordinated these services.
Conclusions: By providing the organizational characteristics of sites participating in the MOMs study, this report assists in filling the current gap in knowledge regarding similar programs providing services to PPI with OUD. Collaborative care programs such as those participating in MOMs are uniquely positioned to participate in research to determine the most effective models of care and to determine how research can be integrated into those clinical care settings.
Related protocols: CTN-0080
Symptom counts as the basis for Post-Traumatic Stress Disorder (PTSD) diagnoses in the DSM presume each symptom is equally reflective of underlying disorder severity. However, the “equal weight” assumption fails to fit PTSD symptom data when tested. The present study, funded in part by CTN-0015, developed an enhanced PTSD diagnosis based on (a) a conventional PTSD diagnosis from a clinical interview and (b) an empirical classification of full PTSD that reflected the relative clinical weights of each symptom.
Baseline structured interview data from Project Harmony (N = 2658) was used. An enhanced diagnosis for full PTSD was estimated using an empirical threshold from moderated nonlinear factor analysis (MNLFA) latent PTSD scale scores, in combination with a full conventional PTSD diagnosis based on interview data.
One in 4 patients in the sample had a PTSD diagnosis that was inconsistent with their empirical PTSD grouping, such that the enhanced diagnostic standard reduced the diagnostic discrepancy rate by 20%. Veterans, and in particular female Veterans, were at greatest odds for discrepancy between their underlying PTSD severity and DSM diagnosis.
Conclusions: Psychometric methodologies that differentially weight symptoms can complement DSM criteria and may serve as a platform for symptom prioritization for diagnoses in future editions of DSM.
Related protocols: CTN-0015
Approximately 40% of participants enrolled in CTN studies are women. Yet, women face unique issues when it comes to getting help with substance use disorder. It can be especially difficult for women to receive assistance for substance use disorder during or after pregnancy and when navigating the criminal justice system due to social stigma, legal issues, or other barriers.
The CTN prioritizes enrollment of women and minorities in research studies and recognizes the issues related to their participation. Accordingly, this 60-minute web seminar will consider the unique challenges that women face in the criminal justice system while struggling with substance use disorder. This will help research teams have a better understanding of the experience of women, including those that are pregnant and in the criminal justice system, and help researchers manage study retention and follow-up more effectively.
Presenters: Ank Nijhawan, MD, MPH (UT Southwestern Medical Center, Dallas, TX), Jaimie Meyer, MD, MS, FACP (Yale University, New Haven, CT), Mishka Terplan, MD, MPH, FACOG, DFASAM (Friends Research Institute, Baltimore, MD)
Learning Objectives:
- Describe the background and treatment of women with substance use in the criminal justice system.
- Discuss unique challenges of women in the criminal justice system, including considerations for pregnant women.
- Consider how this impacts research participation for women who use substances and pregnant women who use substances.
Side effects of medications for opioid use disorder (MOUD) such as weight gain contribute to their stigma. Substantial evidence suggests that women have a more severe side effect profile to MOUD than men, and concerns about weight gain during treatment are prevalent. However, the few studies reporting sex differences in weight gain during treatment show conflicting results and are restricted to methadone. In addition, little is known about possible sex differences in weight gain to buprenorphine, which is the most commonly prescribed MOUD in the United States.
To address these issues, the authors performed a systematic review and meta-analysis on the few studies reporting longitudinal data on sex differences in body mass index (BMI) gain during methadone treatment (Study 1). In a separate study, they also re-analyzed data from trial CTN-0030 of the National Institute on Drug Abuse Clinical Trial Network (NIDA CTN), which involved a 12-week buprenorphine treatment regimen (Study 2; n = 360; 209 Male, 151 Female).
For Study 1, across all papers reporting longitudinal data (k = 4, n = 362 OUD patients), there were BMI increases that ranged from 2.2 to 5.4 BMI after at least one year of methadone treatment, but there were no significant sex differences in BMI increases (Standardized Mean Difference, Female > Male = 0.352, SE =0.270; 95 % CI = [-0.18 0.88]; p = .193). Study 2 showed no significant differences in weight before and after 12 weeks of buprenorphine treatment nor did it show sex differences in weight change with treatment (ß = 2.34, p = .511).
Conclusions: These analyses corroborate evidence of weight gain with methadone treatment but did not observe a sex-based disparity in weight gain with methadone or buprenorphine treatment for OUD.
Related protocols: CTN-0030
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
Opioid use disorder (OUD) and chronic pain frequently co-occur. Little is known about change in pain during buprenorphine/naloxone (BUP/NX) maintenance and whether outcomes vary by pain levels. The present study examined changes in pain intensity and pain interference over 12 weeks of BUP/NX maintenance among participants with OUD and chronic pain (N=194). Differences in outcomes were assessed during BUP/NX maintenance (Week 12) and 2 months following a BUP/NX taper (Week 24). Data from Phase 2 of the CTN Prescription Opioid Addiction Treatment Study (POATS, CTN-0030) were used. Two latent transition models were conducted to characterize profiles and transitions between profiles of pain intensity or pain interference (estimated separately). Each model identified a high and low profile. In the pain interference model, the majority were classified in the low profile at baseline. In the pain intensity model, the majority were classified in the high profile at baseline. In both models, patients were more likely to remain in or transition to the low profiles by Week 12. Worse depression was associated with membership in the high pain interference profile at both timepoints. Women were more likely to be in the high pain intensity profile at baseline. Those in the high intensity and high pain interference profiles at Week 12 reported worse mental health quality of life (MH-QOL) at Week 12, as well as high pain intensity and high pain interference at Week 24.
Conclusions: For a subgroup of patients, high pain intensity and high pain interference remains unchanged during BUP/NX maintenance treatment.
Related protocols: CTN-0030
This study examined the associations of multiple psychiatric and chronic conditions with the self-reported history of major depressive disorder (MDD) among patients with opioid use disorder (OUD) and tested whether the associations differed by gender. Using data from CTN-0027 (START), a clinical trial including 1,646 participants with OUD, of which 465 had MDD, a variable cluster analysis was used to classify chronic medical and psychiatric conditions. Multivariate logistic regression analyses were used to estimate their associations with MDD in subjects with OUD.
Nine variables were divided into three clusters: cluster 1 included heart condition, hypertension, and liver problems; cluster 2 included gastrointestinal (GI) problems and head injury; and cluster 3 included anxiety disorder, bipolar disorder, and schizophrenia. The overall prevalence of MDD in participants with OUD was 28.3% (22.8% for males and 39.5% for females). Gender, anxiety disorder, schizophrenia, liver problems, heart condition, GI problems, and head injury were significantly associated with MDD. Gender-stratified analyses showed that bipolar disorder, liver problems and individuals with one chronic condition were associated with MDD only in males, whereas heart condition, hypertension, and GI problems were associated with MDD only in females. In addition, anxiety disorder, head injury, individuals with one or more than two psychiatric conditions, and individuals with more than two chronic conditions were associated with MDD regardless of gender.
Conclusions: This study showed a high prevalence of MDD in individuals with OUD as compared to the general population. In those with OUD, there is a significant association between MDD and gender, anxiety disorder, liver problems, heart condition, GI problems, and head injury. Furthermore, multiple psychiatric and chronic conditions were significantly associated with MDD. Additionally, gender-stratified analyses showed that bipolar disorder, liver problems and one chronic condition was associated with MDD in males, while heart condition, hypertension, and GI problems were associated with MDD only in females. Treatment plans in patients with OUD should not only address MDD but also co-morbid psychiatric and chronic medical conditions that occur with MDD.
Related protocols: CTN-0027
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.