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Abstract: 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

Abstract:

Background and Objectives: Tobacco smoking and alcohol use disorder (AUD) are highly prevalent among individuals receiving medication for opioid use disorder (MOUD) treatment, yet their combined impact on treatment outcomes remains underexplored. This study investigates the differences in clinical profiles and treatment outcomes based on smoking and AUD status among individuals initiating MOUD.

Methods: This secondary analysis utilized data from a multi-site randomized clinical trial (CTN-0027) evaluating the hepatotoxicity during 24 weeks of buprenorphine or methadone treatment. Participants were categorized into four groups based on baseline smoking and AUD status: Non-AUD/Non-smoker, Smoker Only, AUD Only, and AUD+Smoker. Clinical profiles and treatment outcomes were compared across groups.

Results: Among 973 participants (68.6% male, 70.5% White, mean age 37.5 years), 50% were Smoker Only, 16% AUD+Smoker, 8% AUD Only, and 27% Non-AUD/Non-smoker. Smoking prevalence was high (66%), while AUD prevalence was lower (24%). AUD+Smoker and AUD Only groups had significantly higher rates of additional substance use disorders (p < .01). However, treatment outcomes—measured by urinalysis results, retention, and completion—did not differ significantly across groups.

Discussion and Conclusions: Smoking and AUD status were not associated with poorer MOUD outcomes, but the high prevalence of smoking, and the clustering of additional substance use disorders among individuals with AUD suggest the need for integrated care. These findings support inclusion of adjunctive behavioral and public health interventions within MOUD programs.

Related protocols: CTN-0027

Abstract:

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

Abstract:

Objective: This secondary analysis evaluated the validation results of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) tool for older adults.

Methods: Researchers performed a subgroup analysis of older adults aged =65 (n = 184) from the TAPS tool validation study conducted in 5 primary care clinics (CTN-0059). They compared the interviewer and self-administered versions of the TAPS tool at a cutoff of =1 for identifying problem use with a reference standard measure, the modified World Mental Health Composite International Diagnostic Interview.

Results: The mean age was 70.6 ± 5.9 years, 52.7% were female, and 49.5% were non-Hispanic Black. For identifying problem use, the self-administered TAPS tool had sensitivity of 0.91 (95% CI: 0.75–0.98) and specificity of 0.91 (95% CI: 0.85–0.95) for tobacco; sensitivity of 0.68 (95% CI: 0.45–0.86) and specificity of 0.88 (95% CI: 0.82–0.93) for alcohol; and sensitivity 0.86 (95% CI: 0.42–1.00) and specificity 0.94 (95% CI: 0.90–0.97) for cannabis. The interviewer-administered TAPS tool had similar results. Researchers were unable to evaluate its performance for identifying problem use of individual classes of drugs other than cannabis in this population due to small sample sizes.

Conclusions: While the TAPS had excellent sensitivity and specificity for identifying tobacco use among older adults, the results for other substances lack precision, and we were unable to evaluate its performance for prescription medications and individual illicit drugs in this sample. This analysis underlines the critical need to adapt and validate screening tools for unhealthy substance use, specifically for older populations who have unique risks.

Related protocols: CTN-0059

Abstract:

Compared to the general population, persons entering addiction treatment are three to four times more likely to be tobacco dependent and even addiction treatment staff members are two to three times more likely to be tobacco dependent. In these settings, tobacco use continues to be the norm; however, addiction treatment programs are increasingly aware of the need to assess for and treat tobacco dependence. The problem is a cultural issue that is so ingrained that assumptions about tobacco use and dependence in addiction treatment are rarely questioned. Denial, minimization, and rationalization are common barriers to recovery from other addictions; now is the time to recognize how tobacco use and dependence must be similarly approached. This article describes the Addressing Tobacco through Organizational Change (ATTOC) model, which has successfully helped many addiction treatment programs to more effectively address tobacco use. The article will review the six core strategies used to implement the ATTOC intervention, the 12-step approach guiding the model, and describe a case study where the intervention was implemented in one clinic setting (at Willamette Family Treatment Services, part of the CTN Oregon/Hawaii Node). Other treatment programs may use the experience and lessons learned from this CTN platform study about the ATTOC organization change model to better address tobacco use in the context of drug abuse treatment.

Abstract:

The goal of this study, part of CTN-0140 (Cannabis Use Among Pregnant Women with Polysubstance Use and Psychiatric Problems), was to estimate the strength of association between psychiatric disorders and substance use disorders (SUD), and cannabis use and cannabis use disorder (CUD) during early pregnancy. Participants were 299,496 pregnancies from 227,555 individuals screened for cannabis use by self-report and a urine toxicology test at entrance to prenatal care in Kaiser Permanente Northern California during January 2011-December 2021 (excepting year 2020). The sample was 62.5% non-White, with a mean (standard deviation) age of 31.1 (5.5) years; 6.8% used cannabis; 0.2% had a CUD.

Exposure variables included electronic health record-based psychiatric diagnoses of attention deficit hyperactivity, anxiety, bipolar, depressive, personality, posttraumatic stress and psychotic disorders; and alcohol, opioid, stimulant and tobacco use disorders, during the two years prior to pregnancy up to the day before the prenatal substance use screening date. Outcome variables were any cannabis use, frequency of self-reported cannabis use and CUD during early pregnancy.

Psychiatric disorder prevalence ranged from 0.2% (psychotic) to 14.3% (anxiety), and SUD ranged from 0.3% (stimulant/opioid) to 3.8% (tobacco). Psychiatric disorders were associated with cannabis use and CUD, with the strongest association for any use found for bipolar disorder (adjusted odds ratio [aOR] = 2.83; 95% confidence interval [CI] = 2.53-3.17) and the strongest association for CUD found for psychotic disorders (aOR = 10.01, 95% CI = 6.52-15.37). SUDs were associated with cannabis use and CUD, with the strongest association for any use found for tobacco use disorder (aOR = 4.03, 95% CI = 3.82-4.24) and the strongest association for CUD found for stimulant use disorder (aOR = 21.99, 95% CI = 16.53-29.26). Anxiety, bipolar, depressive disorders and tobacco use disorder were associated with greater odds of daily than monthly or less cannabis use.

Conclusions: Psychiatric disorders and substance use disorders appear to be associated with elevated odds of any and frequent cannabis use as well as cannabis use disorder during early pregnancy. In most cases, the associations with cannabis outcomes were stronger for substance use disorders than other psychiatric disorders.

Related protocols: CTN-0140

Abstract:

Medical cannabis is commonly used for chronic pain, but little is known about differences in characteristics, cannabis use patterns, and perceived helpfulness among primary care patients who use cannabis for pain versus nonpain reasons.

Among 1688 patients who completed a 2019 cannabis survey administered in a health system in Washington state, where recreational use is legal, participants who used cannabis for pain (n = 375) were compared with those who used cannabis for other reasons (n = 558) using survey and electronic health record data. We described group differences in participant characteristics, use patterns, and perceptions and applied adjusted multinomial logistic and modified Poisson regression.

Participants who used cannabis for pain were significantly more likely to report using applied (50.7% vs 10.6%) and beverage cannabis products (19.2% vs 11.6%), more frequent use (47.1% vs 33.1% for use =2 times per day; 81.6% vs 69.7% for use 4 to 7 days per week), and smoking tobacco cigarettes (19.2% vs 12.2%) than those who used cannabis for other reasons. They were also significantly more likely to perceive cannabis as very/extremely helpful (80.5% vs 72.7%), and significantly less likely to use cannabis for nonmedical reasons (4.8% vs 58.8%) or report cannabis use disorder symptoms (51.7% vs 61.1%).

Conclusions: Primary care patients who use cannabis for pain use it more frequently, often in applied and ingested forms, and have more co-use of tobacco, which may differentially impact safety and effectiveness. These findings suggest the need for different approaches to counseling in clinical care.

Related protocols: CTN-0077-Ot

Abstract:

Cocaine use disorder (CUD) is a significant public health issue for which there is no Food and Drug Administration-approved pharmacotherapy. Depressive disorders are common psychiatric comorbidity amongst individuals with CUD.

A retrospective cohort study was conducted among 161,544 patients diagnosed with CUD and depression to evaluate the effectiveness of 13 antidepressants on CUD remission. For any antidepressant found to be associated with CUD remission that had an additional indication, we conducted an additional analysis to evaluate the effectiveness of the candidate drug in patients with CUD with that indication. We then analyzed publicly genomic and functional databases to identify potential explanatory mechanisms of action of the candidate drug in the treatment of CUD.

Among these antidepressants, bupropion was associated with higher rates of CUD remission compared to propensity-score matched patients prescribed other antidepressants: hazard ratio (HR) and 95% confidence interval (CI) 1.57 (95% CI: 1.27-1.94). Bupropion is also approved for smoking cessation. We identified CUD patients with co-occurring nicotine dependence and observed that patients prescribed bupropion displayed a higher rate of CUD remission compared to matched individuals prescribed other drugs for nicotine dependence: 1.38 (95% CI: 1.11-1.71). Genetic and functional analyses revealed that bupropion interacts with four protein-encoding genes (COMT, DRD2, SLC6A3, and SLC6A4) which are also associated with CUD and targets CUD-associated pathways including serotonergic synapses, cocaine addiction, and dopaminergic synapses.

Conclusions: Our findings suggest that bupropion might be considered a treatment for improving CUD remission in patients with CUD and co-occurring depression or nicotine dependence.

Related protocols: CTN-0114

Abstract:

Screening for substance use in rural primary care clinics faces unique challenges due to limited resources, high patient volumes, and multiple demands on providers. To explore the potential for electronic health record (EHR)-integrated screening in this context, researchers conducted an implementation feasibility study with a rural federally-qualified health center (FQHC) in Maine. This was an ancillary study to a NIDA Clinical Trials Network study of screening in urban primary care clinics (CTN-0062).

Researchers worked with stakeholders from three FQHC clinics to define and implement their optimal screening approach. Clinics used the Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) Tool, completed on tablet computers in the waiting room, and results were immediately recorded in the EHR. Adult patients presenting for annual preventive care visits, but not those with other visit types, were eligible for screening. Data were analyzed for the first 12 months following implementation at each clinic to assess screening rates and prevalence of reported unhealthy substance use, and documentation of counseling using an EHR-integrated clinical decision support tool, for patients screening positive for moderate-high risk alcohol or drug use.

Screening was completed by 3749 patients, representing 93.4% of those with screening-eligible annual preventive care visits, and 18.5% of adult patients presenting for any type of primary care visit. Screening was self-administered in 92.9% of cases. The prevalence of moderate-high risk substance use detected on screening was 14.6% for tobacco, 30.4% for alcohol, 10.8% for cannabis, 0.3% for illicit drugs, and 0.6% for non-medical use of prescription drugs. Brief substance use counseling was documented for 17.4% of patients with any moderate-high risk alcohol or drug use.

Conclusions: Self-administered EHR-integrated screening was feasible to implement, and detected substantial alcohol, cannabis, and tobacco use in rural FQHC clinics. Counseling was documented for a minority of patients with moderate-high risk use, possibly indicating a need for better support of primary care providers in addressing substance use. There is potential to broaden the reach of screening by offering it at routine medical visits rather than restricting to annual preventive care visits, within these and other rural primary care clinics.

Related protocols: CTN-0062-Ot

Abstract:

Methamphetamine (MA) use is marked by high rates of comorbid tobacco smoking, which is associated with more severe drug use and worse clinical outcomes compared to single use of either drug. Research has shown the combination of naltrexone plus oral bupropion (NTX-BUP) improves smoking cessation outcomes in non-MA-using populations. In the National Drug Abuse Treatment Clinical Trials Network (CTN) Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) study, NTX-BUP successfully reduced MA use. Our aim in this secondary data analysis was to examine changes in cigarette smoking among the subgroup of participants reporting comorbid tobacco use in the ADAPT-2 trial.

The multi-site ADAPT-2 study used a randomized, double blind, sequential parallel comparison design to evaluate treatment with extended-release injectable NTX (380 mg every 3 weeks) combined with once-daily oral extended-release BUP (450 mg/day) vs matching injectable and oral placebo in outpatients with moderate or severe MA use disorder. The study assessed smoking outcomes, based on self-reported timeline followback (TLFB) data, twice/week for 13 weeks.

Of the 403 participants in the ADAPT-2 trial, 290 reported being current cigarette smokers (71.9 %). The study found significant differences (p’s < 0.0001) for each smoking outcome indicating greater change in the proportion of nonsmoking days, number of cigarettes smoked per week, and consecutive nonsmoking days, all favoring the group receiving NTX-BUP versus placebo.

Conclusions: NTX-BUP was associated with significant reductions in self-reported cigarette smoking in the context of concurrent treatment for MA use disorder. These off-target medication effects warrant prospective investigation using biochemically confirmed measures of smoking abstinence. The development of NTX-BUP as a co-addiction treatment strategy has a potential for high public health impact.

Related protocols: CTN-0068

Abstract:

The aim of this exploratory analysis was to evaluate cannabis exposure, reasons for use and problematic cannabis use among adult primary care patients in Washington State (United States) who co-use cannabis and nicotine (tobacco cigarettes and/or nicotine vaping) compared to patients who endorse current cannabis use only. As part of a NIDA Clinical Trials Network (CTN-0077-Ot) parent study, patients who completed a cannabis screen as part of routine primary care were randomly sampled (N=5000) to receive a confidential cannabis survey. Patients were stratified and oversampled based on the frequency of past-year cannabis use and for Black, indigenous, or other persons of color. Patients who endorsed past 30-day cannabis use are included here (N=1388). Outcomes included: prevalence of cannabis use, days of cannabis use per week and times used per day, methods of use, THC:CBD content, non-medical and/or medical use, health symptoms managed, and cannabis use disorder (CUD) symptom severity. Researchers conducted unadjusted bivariate analyses comparing outcomes between patients with cannabis and current nicotine co-use to patients with cannabis-only use. Nicotine co-use (n = 352; 25.4 %) was associated with differences in method of cannabis use, THC:CBD content, days of use per week and times used per day, number of health symptoms managed, and CUD severity (all p < 0.001), compared to primary care patients with cannabis-only use (n = 1036).

Conclusions: Primary care patients in Washington state who reported cannabis-nicotine co-use reported greater cannabis use frequency, a greater number of health symptoms managed by cannabis, and greater prevalence of CUD compared to patients who only used cannabis. Additional research focused on screening and intervention is warranted on co-use among primary care patients given the adverse health outcomes associated with co-use and potential treatment implications for single or dual substance cessation. These results highlight the importance of, at minimum, identification of co-use within a primary care setting in order to refer and/or intervene on use.

Related protocols: CTN-0077-Ot

Abstract:

Cannabis use is common among individuals with pain who are prescribed opioids, occurring in approximately 10% of this population. This study aimed to explore the relationship between non-medical cannabis use and other health risks among individuals filling opioids at community pharmacies.

This study was an exploratory secondary data analysis of a National Drug Abuse Treatment Clinical Trials Network (CTN)-sponsored study, Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening (CTN-0093), examining the relationship between risky cannabis use and depressive symptoms, pain, overdose, and other substance misuse among individuals filling opioid prescriptions in community pharmacies (N = 1440).

Participants reporting moderate- to high-risk compared to low-risk cannabis use were more likely to report depressive symptoms (adjusted OR = 1.67, 95% CI = 1.11–2.56), history of overdose (adjusted OR = 2.15, 95% CI = 1.34–3.44), and moderate- to high-risk use of alcohol (adjusted OR = 2.10, 95% CI = 1.28–3.45), opioids (adjusted OR = 2.50, 95% CI = 1.67–3.76), sedatives (adjusted OR = 2.58, 95% CI = 1.72–3.86), stimulants (adjusted OR = 4.79, 95% CI = 2.83–8.01), and tobacco (adjusted OR = 3.60, 95% CI = 2.47–5.24).

Conclusion: Community pharmacies may be valuable sites for identifying, studying, and intervening with substance use problems.

Related protocols: CTN-0093

Abstract:

Primary care settings provide salient opportunities for identifying patients with problematic substance use and addressing unmet treatment needs. The aim of this study was to examine the extent and correlates of problematic substance use by substance-specific risk categories among primary care patients to inform screening/intervention efforts.

This secondary analysis of CTN-0059 (TAPS Tool) looked at data from 2000 adult primary care patients aged 18 or older (56% female) across 5 clinics in the eastern U.S. Participants completed the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Prevalence and ASSIST-defined risk-level of tobacco use, alcohol use, and nonmedical/illicit drug use was examined. Multinomial logistic regression models analyzed the demographic correlates of substance use risk-levels.

Among the total sample, the prevalence of any past 3-month use was 53.9% for alcohol, 42% for tobacco, 24.2% for any illicit/Rx drug, and 5.3% for opioids; the prevalence of ASSIST-defined moderate/high-risk use was 45.1% for tobacco, 29% for any illicit/Rx drug, 14.2% for alcohol, and 9.1% for opioids. Differences in the extent and risk-levels of substance use by sex, race/ethnicity, and age group were observed. Adjusted logistic regression showed that male sex, white race, not being married, and having less education were associated with increased odds of moderate/high-risk use scores for each substance category; older ages (versus ages 18-25 years) were associated with increased odds of moderate/high-risk opioid use.

Conclusions: Intervention need for problematic substance use was prevalent in this sample. Providers should maintain awareness and screen for problematic substance use more consistently in identified high risk populations.

Related protocols: CTN-0059

Abstract:

Substance use disorder (SUD) management by medical providers may be important for patients with comorbid health conditions exacerbated by SUD. This study, supported by protocol CTN-0080 (Medication Treatment for Opioid Use Disorder in Expectant Mothers), evaluated potential associations of SUD with morbidity and mortality in a large sample of hypertensive patients.

Analysis of a limited data set was obtained through IBM Watson Health Explorys, a platform integrating data from electronic health records. Matched controls were defined for each of five SUDs: tobacco use disorder (TUD), alcohol use disorder (AUD), cocaine use disorder (SOUD), opioid use disorder (OUD), and cannabis use disorder (CUD) using Mahalanobis distance within propensity score calipers. All patients were from the MetroHealth System (Cleveland, OH) and had diagnosed hypertension. SUD group participants had diagnosed abuse/dependence for the substance of interest. Controls for each SUD group had no diagnosis code related to the substance of interest and were selected to match the SUD patients on several factors. Total sample sizes for each SUD-control comparison ranged from 3,176 (CUD) to 49,696 (TUD); proportions of female patients ranged from 31.7% (AUD) to 51.2% (TUD). Outcomes were diagnosis (yes/no) of the following: cerebrovascular accident, myocardial infarction, renal failure, and all-cause mortality.

Logistic regressions revealed that SUD was significantly associated with cerebrovascular accident, renal failure, myocardial infarction, and mortality.

Conclusions: Among patients with hypertension, those with SUDs appear to have significantly greater risk for morbidity and mortality, suggesting the importance of managing SUD in hypertensive patients.

Abstract:

This study, part of CTN-0053, evaluated the associations between regular cannabis use, with and without tobacco co-use, and cardiovascular outcomes.

Using electronic health records, control patients, with no cannabis-use-documentation, were matched to the cannabis-using patients on demographics, residential zip code median income, body mass index, and, for the total sample, tobacco use disorder (TUD) status. Outcomes were encounter diagnosis (yes/no) of cerebrovascular accident (CVA), heart arrhythmia, myocardial infarction, subarachnoid hemorrhage (SAH), and all-cause mortality.

TUD-patients had the greatest prevalence of cardiovascular disease, regardless of cannabis-use indication. In the total sample and non-TUD subgroup, regular cannabis use was significantly associated with greater risk for CVA, arrhythmia, SAH, and mortality. In the TUD subgroup, regular cannabis use was significantly associated with greater risk for arrhythmia and SAH.

Conclusions: Cannabis use is associated with significantly greater risk of adverse cardiovascular diagnoses and overall death, particularly in non-tobacco users.

Related protocols: CTN-0053