Bidirectional associations between self-regulation and deviance from adolescence to adulthood.

Self-regulation is considered a major predictor of crime and deviant behavior. However, longitudinal research investigating these associations, frequently looked only at the effect of self-regulation on deviant behavior, but not the other way around. The current study argued that deviance may contribute to later problems in self-regulation, and examined bidirectional associations, comparing a unidirectional and bidirectional model of associations between these variables. A Random Intercept Cross-Lagged Panel Model and eight data waves from 772 participants, aged 10-12 years to 30 years were used. Results showed that a bidirectional model fit the data better than a unidirectional model. The final model revealed an influence of deviance on self-regulation mainly in adolescence, whereas self-regulation influenced deviance only over two time points in adulthood. The results suggest that, in adolescence, problems in self-regulation may follow, rather than precede deviant behavior. Thus, decreasing deviant behavior or intervening in the aftermaths of deviant behavior in adolescence might have a positive effect on self-regulation in young adulthood, lowering the chance of adult deviant behavior. The current study shows that the long-presumed directionality of self-regulation to deviance can lead to bias, and more rigorous longitudinal research is needed in order to further inform theory and practice.

Do the Transmissible Liability Index (TLI) and Adolescent Cannabis Use Predict Paranoid and Schizotypal Symptoms at Young Adulthood?

Background: Adolescent cannabis use is an established risk factor for the development of psychosis, but the premorbid vulnerability factors and specificity versus generality of the psychotic symptom domains affected in cannabis-psychosis relationships remain incompletely understood. To improve our understanding of these relationships, we used longitudinal data to examine the individual and interactive effects of preadolescent transmissible liability to substance use disorders (SUD), measured via the transmissible liability index (TLI), and adolescent cannabis use on the development of two distinct psychotic symptom domains, paranoid and schizotypal personality traits in young adulthood. Methods: We performed secondary analysis of data from the Center for Education and Drug Abuse (CEDAR) study, which longitudinally assessed offspring of men with (N = 211) and without (N = 237) lifetime history of SUD at ages 10-12, and across adolescence as they transitioned to young adulthood. TLI scores were calculated at age 10-12, self-reported cannabis use was assessed at age 16, and paranoid and schizotypal symptoms were assessed at age 19. Results: Cannabis use at age 16 and family history of SUD were significantly associated with paranoid and schizotypal symptoms at age 19, but TLI scores were not. The interactive effect of TLI x cannabis use was also not significant. Paranoid and schizotypal symptoms showed different dose-dependent sensitivities to cannabis exposure at age 16. Conclusions: These findings indicate that adolescent cannabis use and family history of SUD differentially contribute to the development of paranoid and schizotypal personality traits through mechanisms that do not include behavioral disinhibition.

Forecasting Opioid Use Disorder at 25 Years of Age in 16-Year-Old Adolescents.

OBJECTIVE: To evaluate the accuracy of detecting 16-year-old male (n = 465) and female (n = 162) youths who subsequently manifest opioid use disorder (OUD) at 25 years of age. We hypothesized that the combined measures of 2 components of etiology, heritable risk, and substance use, accurately detect youths who develop OUD. STUDY DESIGN: Heritable risk was measured by the transmissible liability index (TLI). Severity of the prodrome presaging OUD was quantified by the revised Drug Use Screening Inventory containing the consumption frequency index (CFI) documenting substance use events during the past month and the overall problem density (OPD) score indicating co-occurring biopsychosocial problems. Diagnosis of OUD was formulated by a clinical committee based on results of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition in conjunction with medical and social history records. RESULTS: Bivariate analysis shows that the TLI, CFI, and OPD scores at 16 years of age predict OUD at 25 years. Multivariate modeling indicates that the TLI combined with the CFI predict OUD with 86% accuracy (sensitivity = 87%; specificity = 62%). The TLI and CFI at 16 years of age mediate the association between parental substance use disorder and OUD in offspring at 25 years of age, indicating that these measures respectively evaluate risk and prodrome. CONCLUSIONS: These results demonstrate the feasibility of identifying youths requiring intervention to prevent OUD.

Derivation and assessment of the opioid use disorder severity scale: prediction of health, psychological and social adjustment problems.

Background: Severity of substance use disorder (SUD) is typically evaluated by tabulating the number of symptoms. The resulting estimate of disorder severity is, however, biased due to intercorrelations among symptoms and their unequal salience. Objective. Employing item response theory (IRT) methodology, opioid use disorder symptoms were calibrated to derive the Opioid Use Disorder Severity Scale (OUDSS) and assess its predictive ability in men and women separately. Methods: A two-parameter IRT model was utilized to derive the OUDSS from DSM-IV symptoms recorded on the Structured Clinical Interview for DSM-IV (SCID) in 438 men and 429 women who reported at least one lifetime opioid consumption event. The predictive ability of the OUDSS was evaluated using the 10 health, psychological, and social adjustment domains of the revised Drug Use Screening Inventory (DUSI-R) assessed 2 years later. Results: The OUDSS score predicted the severity of problems in all 10 DUSI-R domains in men and women. The OUDSS also predicted the DUSI-R diagnostic cutoff score of overall problem density score in men and women (OR = 2.21 and OR = 4.83, respectively). Withdrawal was the most frequently endorsed symptom in this sample of opioid users. The other symptoms' frequencies, while somewhat lower than withdrawal's, did not differ from it substantially, indicating a similar severity threshold. Conclusions: OUDSS enables dimensional measurement of opioid use severity on an interval scale. The OUDSS and DUSI-R together can identify problem areas requiring prevention or treatment.

Correspondence of Pubertal Neuroendocrine and Tanner Stage Changes in Boys and Associations With Substance Use.

This study examined correspondence between timing (onset) and tempo (rate) of sexual maturation prospectively (average ages 11-16 years) measured by gonadal hormones and secondary sex characteristics (Tanner stage) using dual-process models, and associations of these measures with substance use (SU) involvement in boys at age 16 years (N = 534, 77.5% White/22.5% Non-White). All measures of timing were highly associated. Early Tanner stage timing often predicted slower increases in gonadal steroids, but not the reverse; patterns varied by ethnicity. Hormone and Tanner stage measures were similar earlier in development but diverged later in development. In White boys only, early timing of the pubertal rise in testosterone was associated with increased SU involvement, suggesting a physiological rather than psychosocial mechanism of association.

Association of cognitive function and liability to addiction with childhood herpesvirus infections: A prospective cohort study.

Liability to substance use disorder (SUD) is largely nonspecific to particular drugs and is related to behavior dysregulation, including reduced cognitive control. Recent data suggest that cognitive mechanisms may be influenced by exposure to neurotropic infections, such as human herpesviruses. In this study, serological evidence of exposure to human herpesvirus Herpes simplex virus Type 1 (HSV-1), cytomegalovirus (CMV), and Epstein-Barr virus (EBV) as well as Toxoplasma gondii was determined in childhood (age ~11 years) in 395 sons and 174 daughters of fathers with or without SUD. Its relationships with a cognitive characteristic (IQ) in childhood and with risk for SUD in adulthood were examined using correlation, regression, survival, and path analyses. Exposure to HSV-1, EBV, and T. gondii in males and females, and CMV in males, was associated with lower IQ. Independent of that relationship, EBV in females and possibly in males, and CMV and possibly HSV-1 in females were associated with elevated risk for SUD. Therefore, childhood neurotropic infections may influence cognitive development and risk for behavior disorders such as SUD. The results may point to new avenues for alleviating cognitive impairment and SUD risk.

A community pharmacy intervention for opioid medication misuse: A pilot randomized clinical trial.

OBJECTIVES: Community pharmacy continues to play a crucial role in the national response to the opioid epidemic. The purpose of this article is to describe the protocol for a pilot study that is examining the feasibility and acceptability of the Motivational Intervention-Medication Therapy Management (MI-MTM) model. This study also examines the preliminary clinical effect of MI-MTM for improving opioid medication misuse and patient activation in self-management of health conditions that increase risk for misuse. DESIGN: MI-MTM is a pharmacy-based integrated care model made up of 4 evidence-based practices: medication therapy management; brief motivational intervention; patient navigation; and naloxone training and referral. To test MI-MTM compared with Standard Medication Counseling (SMC), we are conducting a 2-group randomized single-blinded controlled trial with assessments at 3 time points. SETTING AND PARTICIPANTS: The study is being conducted within a western Pennsylvania university-based community pharmacy with 46 patients with opioid misuse (MI-MTM = 23; SMC = 23). MAIN OUTCOME MEASURES: Feasibility will be measured by capturing patient completion rate of MI-MTM sessions. Acceptability will be measured by administering satisfaction surveys regarding pharmacist and patient navigator services. Acceptability will also be captured by conducting intensive qualitative interviews. Preliminary effect of the intervention on misuse will be measured with the use of the Prescription Opioid Misuse Index and the Opioid Compliance Checklist. Activation in self-management will be measured with the use of the Patient Activation Measure. RESULTS: This project is currently recruiting, and results are to come. CONCLUSION: This study is the first in the United States to implement an evidence-based integrated behavioral intervention into the community pharmacy setting to address opioid medication misuse among pharmacy patients. The results of this study will provide necessary foundational data that allow further testing of this intervention model in a larger trial.

Dose-adjusted plasma concentrations of sublingual buprenorphine are lower during than after pregnancy.

BACKGROUND: Buprenorphine is a Food and Drug Administration-approved maintenance therapy for opioid use disorders and is increasingly being used in pregnant women with opioid use disorders as an alternative to methadone. Dosing of buprenorphine in pregnant women is based on the regimen recommended for nonpregnant females and males. Limited data are available defining the pharmacokinetic properties of sublingual buprenorphine administered during pregnancy. OBJECTIVE: This study evaluated the impact of physiological changes associated with pregnancy on the pharmacokinetics of sublingual buprenorphine during and after pregnancy. STUDY DESIGN: Pregnant women (n = 13), between 180/7 and 376/7 weeks' singleton gestation, receiving sublingual buprenorphine twice daily for opioid use disorders were studied. Pharmacokinetic-2 studies were performed between 18 and 25 weeks (n = 7), pharmacokinetic-3 studies were performed between 31 and 37 weeks (n = 11), and pharmacokinetic-P was performed 4-18 weeks postpartum (n = 10). On the day of the study, blood was withdrawn prior to the daily morning dose of buprenorphine and at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, and 12 hours after the dose. Buprenorphine plasma concentrations were analyzed by liquid chromatography tandem mass spectrometric detection. All pharmacokinetic parameters were observed or estimated using Microsoft Excel. Statistical analyses were performed to identify significant changes in study participants' buprenorphine pharmacokinetic parameter estimates over the duration of the study. Univariate linear and generalized linear mixed models were used to investigate changes in these measures over time, some of which were log transformed for normality. RESULTS: Dose-normalized (plasma concentration per dose) buprenorphine plasma concentrations were significantly lower during pregnancy (pharmacokinetic-2 plus pharmacokinetic-3) than during the postpartum period (pharmacokinetic-P). Specific pharmacokinetic parameters (and level of significance) were as follows: the area under the buprenorphine plasma concentration-time curves (P < .003), maximum buprenorphine concentrations (P < .018), buprenorphine concentrations at 0 hour (P < .002), and buprenorphine concentrations at 12 hours (P < .001). None of these parameters differed significantly during pregnancy (ie, pharmacokinetic-2 vs pharmacokinetic-3). The time to maximum buprenorphine concentrations did not differ significantly between groups. CONCLUSION: The dose-normalized plasma concentrations during a dosing interval and the overall exposure of buprenorphine (area under the buprenorphine plasma concentration-time curves) are lower throughout pregnancy compared with the postpartum period. This indicates an increase in apparent clearance of buprenorphine during pregnancy. These data suggest that pregnant women may need a higher dose of sublingual buprenorphine compared with postpartum individuals. The dose of buprenorphine should be assessed after delivery to maintain similar buprenorphine exposure during the postpartum period.

Prescription opioid use: Patient characteristics and misuse in community pharmacy.

OBJECTIVES: Opioid pain medication misuse is a major concern for US public health. The purpose of this article is to: 1) describe the demographic and physical, behavioral, and mental health characteristics of patients who fill opioid medications in community pharmacy settings; and 2) describe the extent of opioid medication misuse behaviors among these patients. DESIGN: We recruited and screened a convenience sample of patients with the use of a tablet computer-based assessment protocol that examined behavioral, mental, and physical health. Descriptive and inferential statistics were calculated to describe respondents and their opioid medication misuse and health characteristics. SETTING: Patients were screened in 2 urban and 2 rural community pharmacies in southwestern Pennsylvania. PARTICIPANTS: Survey participants were adult patients filling opioid pain medications who were not currently receiving treatment for a cancer diagnosis. INTERVENTION: None. MAIN OUTCOME MEASURES: Validated screening measures included the Prescription Opioid Misuse Index, Alcohol Use Disorders Identification Test C, Short Form 12, Drug Abuse Screening Test 10, Primary Care Post-traumatic Stress Disorder (PTSD) screen, and the Patient Health Questionnaire 2. RESULTS: A total of 333 patients were screened (71.2% response rate). Nearly the entire population reported pain above and general health below national norms. Hydrocodone (19.2%) and morphine (20.8%) were found to be the medications with the highest rates of misuse-with hydrocodone having more than 4 times higher odds of misuse compared with other medications (adjusted odds ratio [AOR] 4.48, 95% confidence interval [CI] 1.1-17.4). Patients with positive screens for illicit drug use (AOR 8.07, 95% CI 2.7-24.0), PTSD (AOR 5.88, 95% CI 2.3-14.7), and depression (AOR 2.44, 95% CI 1.0-5.9) also had significantly higher odds for misuse compared with those with negative screening results. CONCLUSION: These findings provide important foundational data that suggest implementation of regular opioid misuse screening protocols within community pharmacies. Such screening activities could foster a culture of prevention and overall reduction for misuse among patients filling opioid medications in community pharmacies.

Genetic relationship between the addiction diagnosis in adults and their childhood measure of addiction liability.

Transmissible liability index (TLI), developed employing a high-risk design and item response theory, enables quantification of the latent trait of liability to drug use disorders (DUD) in children. TLI has been shown to have high heritability and predict DUD in young adulthood. This study extends prior research and determines the genetic contribution of DUD liability measured by TLI to adult liability as indexed by DUD diagnosis. The study utilizes data from a twin sample tracked from age 11 to age 25. In addition to confirming TLI's high heritability and predictive validity, it shows that the genetic component of variance in TLI assessed in childhood accounts for over half of the genetic variance in DUD diagnosis and the entire phenotypic relationship between the two liability measures. This validates TLI as an early measure of DUD liability and supports its utility in early-age genetic and other mechanistic studies of DUD.

Review of hookah tobacco smoking among college students: policy implications and research recommendations.

BACKGROUND: About 30% of college students have smoked hookah tobacco. Although most students perceive this product to be innocuous and non-addictive, hookah tobacco increases the risk for disease and nicotine dependence. Currently, the US Food and Drug Administration (FDA) does not regulate the manufacture, distribution, or sale of hookah tobacco. OBJECTIVE: Empirical literature pertaining to hookah tobacco smoking is reviewed with a focus on the implications for regulatory policy. METHODS: PubMed, PsycINFO, and Scopus databases were searched to locate articles published in English. The literature search combined several key words including "hookahs", "college", "advertising", "health effects", and "health policy". RESULTS: Smoking hookah tobacco may play a role in the initiation of smoking among tobacco-naïve college students and may portend persistent smoking among those who have smoked cigarettes. College students are typically nondaily, social smokers. They do not perceive that their heightened risk for tobacco diseases and nicotine dependence relates to their smoking behavior. However, few public health messages target college-age adults to counter media messages that endorse hookah tobacco smoking. CONCLUSION: Given that the FDA is not authorized to ban specific tobacco products, policy actions should focus on the development of effective risk communication strategies that target college-age adults and on limiting the accessibility of hookah tobacco products to these adults. Accordingly, a research agenda that would inform these policy actions is proposed.

Does the Transmissible Liability Index (TLI) assessed in late childhood predict suicidal symptoms at young adulthood?

OBJECTIVE: Our previous work demonstrated that the Transmissible Liability Index (TLI), an instrument designed as an index of liability for substance use disorder (SUD), is associated with risk of substance use disorder. This longitudinal study assessed whether TLI measured in 10-12-year-olds (late childhood) predicts suicidal behavior from age 12-14 (preadolescence) to age 25 (young adulthood). We hypothesized that TLI would predict number and severity of suicide attempts. METHODS: Subjects were sons of men who had lifetime history of SUD (n = 250), called the High Average Risk (HAR) group, and sons of men with no lifetime history of a SUD (n = 250), called the Low Average Risk (LAR) group. The TLI was delineated at baseline (age 10-12), and age-specific versions were administered at 12-14, 16, 19, 22, and 25 years of age. RESULTS: TLI was significantly associated with number and severity of lifetime suicide attempts. CONCLUSIONS: These findings confirm the hypothesis that TLI assessed at late childhood is a predictor of frequency and severity of suicidal behavior from preadolescence to young adulthood.

Temperament disturbances measured in infancy progress to substance use disorder 20 years later.

OBJECTIVE: This prospective study determined whether temperament before two years of age predicts transmissible risk for substance use disorder (SUD) up to a decade later and SUD outcome in adulthood. METHOD: Boys between 10 and 12 years of age (N = 482) were tracked to age 22. The previously validated transmissible liability index (TLI) was administered at baseline, and temperament prior to two years of age was retrospectively rated. The Structured Clinical Interview for DSM-III-R (SCID) was administered to document presence/absence of SUD for parents at baseline and sons at age 22. RESULTS: Path analysis revealed that number of parents with SUD predicted severity of temperament disturbance in their sons which in turn predicted TLI score at age 10-12, presaging SUD. Temperament before age two did not predict SUD at age 22. The association between number of SUD parents and transmissible risk was mediated by severity of temperament disturbance. CONCLUSION: Temperament disturbance in early childhood, reflecting quality of behavioral and emotion regulation, comprise psychological antecedents of transmissible risk for SUD.

Does stress mediate the development of substance use disorders among youth transitioning to young adulthood?

BACKGROUND: Stress is a well-documented factor in the development of addiction. However, no longitudinal studies to date have assessed the role of stress in mediating the development of substance use disorders (SUD). Our previous results have demonstrated that a measure called Transmissible Liability Index (TLI) assessed during pre-adolescent years serves as a significant predictor of risk for substance use disorder among young adults. However, it remains unclear whether life stress mediates the relationship between TLI and SUD, or whether stress predicts SUD. METHODS: We conducted a longitudinal study involving 191 male subjects to assess whether life stress mediates the relationship between TLI as assessed at age 10-12 and subsequent development of SUD at age 22, after controlling for other relevant factors. RESULTS: Logistic regression demonstrated that the development of SUD at age 22 was associated with stress at age 19. A path analysis demonstrated that stress at age 19 significantly predicted SUD at age 22. However, stress did not mediate the relationship between the TLI assessed at age 10-12 and SUD in young adulthood. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: These findings confirm that stress plays a role in the development of SUD, but also shows that stress does not mediate the development of SUD. Further studies are warranted to clarify the role of stress in the etiology of SUD.

Psychological dysregulation during adolescence mediates the association of parent-child attachment in childhood and substance use disorder in adulthood.

OBJECTIVE: This prospective study tested the hypothesis that psychological dysregulation in mid-adolescence (age 16) mediates the association between parent-child attachment in late childhood (age 10-12) and development of substance use disorder (SUD) in adulthood (age 22). METHOD: The Youth Attachment to Parents Scale (YAPS) was developed in 10-12-year-old boys and girls (N = 694) at baseline residing in western Pennsylvania. Psychological dysregulation was measured by the neurobehavior disinhibition trait. Substance use was assessed at ages 10-12, 12-14, 16 and 19. SUD was diagnosed at age 22 using the Structured Clinical Interview for DSM Disorders. The mediation of parent-child attachment and SUD by neurobehavior disinhibition was tested separately for mothers and fathers while controlling for baseline substance use. RESULTS: Psychological dysregulation mediates the association between attachment to mothers and SUD, and partially mediates the association between attachment to fathers and SUD. Significant mediation effects remains after controlling for baseline substance use. CONCLUSION: Optimal prevention of SUD should include ameliorating both psychological dysregulation predisposing to SUD and quality of the parent-child relationship.

A new approach to researching the etiology of cannabis use disorder: integrating transmissible and nontransmissible risk within a developmental framework.

Rapidly occurring changes in law enforcement and licensing of retail outlets to sell marijuana raises the prospect that the population of consumers will expand and accordingly the prevalence of cannabis use disorder (CUD) will increase. This report presents a novel approach to researching CUD etiology joining multivariate and ontogenetic perspectives. CUD is conceptualized as a developmental outcome consisting of transmissible (intergenerational) and nontransmissible components. Partitioning the liability for CUD into these 2 dimensions enables implementing interventions targeted at the particular source and severity of risk. In addition, results showing that infant temperament disturbances predict transmissible risk leading to CUD 2 decades later underscore the importance of implementing early prevention.

Amygdala Activation and Emotional Processing in Adolescents at Risk for Substance Use Disorders.

Studies are needed that examine neurobiological characteristics in high risk individuals prior to substance use disorder (SUD) development. In this pilot study, 4 adolescent subjects at high risk (having at least 1 parent with a SUD) for SUD were compared with 4 adolescent reference subjects on a corticolimbic reactivity paradigm, where they were presented with affect-laden faces or geometric shapes. FMRI was used to measure cortical activation in response to these stimuli. High risk subjects, compared to low risk, exhibited greater left amygdala activation (t=3.60, df=6, p=0.01), suggesting they may exhibit hyper-responsivity of the amygdala in response to emotional stimuli.

Pharmacist-implemented intervention to surmount COVID-19 vaccination hesitancy in adults with substance use disorders.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: Substance use disorders (SUDs) increase the risk and severity of infectious diseases, including coronavirus disease 2019 (COVID-19). Adults with a co-occurring SUD and psychiatric disorder were studied to elucidate the association between SUD severity and (1) COVID-19 vaccination status, (2) receptivity to a one-session intervention with a pharmacist advocating the benefits of vaccination, and (3) acceptance of referral for vaccination following the intervention. METHODS: COVID-19 vaccination status was recorded in 460 adults with SUD (324 males and 136 females) upon entry into inpatient treatment. A 2-parameter item response theory (IRT) model quantified SUD severity. Pharmacist-delivered intervention, modeled after the screening, brief intervention, and referral to treatment (SBIRT) protocol, was offered to unvaccinated participants. RESULTS: Higher SUD severity was associated with a lower vaccination rate. Nicotine, opioid, and sedative use disorders were most frequently associated with unvaccinated status. SUD severity was not associated with receptivity to intervention advocating vaccination or subsequent acceptance of a referral for vaccination. The portion of the sample that received the intervention was over 7 times more likely to accept a referral for vaccination when compared to participants who rejected the intervention (20.8% vs 2.8%). CONCLUSION: Pharmacist-administered intervention produced motivation for vaccination in a number of recipients; however, receptivity to the intervention was not related to SUD severity.

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial.

BACKGROUND AND AIMS: Patient navigation (PN) may benefit pregnant individuals with opioid use disorder (OUD) by improving treatment adherence. We examined participant enrollment, session delivery and assessment feasibility for a PN intervention among pregnant participants and compared PN preliminary effectiveness for OUD treatment engagement with participants in usual care (UC). DESIGN: This study was a pilot single-blinded multi-site randomized trial. SETTING: Two academic medical centers in Pennsylvania (n = 57) and Utah (n = 45), United States participated. PARTICIPANTS: One hundred and two pregnant adult participants unestablished (fewer than 6 weeks) on medication for OUD (MOUD) were randomized to PN (n = 53) or UC (n = 49). INTERVENTION: PN was composed of 10 prenatal sessions (delivered after baseline but before the prenatal assessments) and four postnatal sessions (delivered before the 2- and 6-month postpartum assessments) focused upon OUD treatment and physical/mental health needs. UC involved brief case management. MEASUREMENTS: Feasibility assessments included consent, session delivery and assessment rates. Mixed-effect models for intent-to-treat (ITT) and per protocol (PP, received six or more sessions) populations were estimated to compare outcomes of MOUD use, secondary outcomes of substance use disorder (SUD) treatment attendance and non-prescribed opioid use, and exploratory outcome of overdose at baseline, predelivery and 2 and 6 months postpartum. FINDINGS: We consented 87% (106 of 122) of the proposed target, delivered ~60% of sessions delivered and completed ≥ 75% assessments. PN ITT and PP had better MOUD adherence, SUD treatment attendance, non-prescribed opioid use and overdose outcomes than UC. Notable changes included good evidence for greater percentage change in days for PN PP MOUD use from baseline to 2 months postpartum [PN = 28.0 versus UC = -10.9, 95% confidence interval (CI) = 9.7, 62.1] and some evidence for baseline to 6 months postpartum (PN = 45.4 versus UC = 23.4, 95% CI = -0.7, 48.2). PN PP percentage change in days for SUD treatment attendance also showed good evidence for improvements from baseline to prenatal assessment (PN = 7.4 versus UC = -21.3, 95% CI = 3.3, 53.5). PN compared to UC participants reported fewer overdoses at 2 months (PN = 11.9%/UC = 16.1%) and at 6 months postpartum (PN = 3.8%/UC = 6.2%). CONCLUSIONS: Patient navigation appears to be associated with improvements in opioid use disorder treatment engagement and overdoses during pregnancy. This pilot trial shows the feasibility of the intervention and a future large-scale trial.