Michelle R. Lent

Importance: Adjunctive psychosocial treatments are recommended for many using medications for opioid use disorder (MOUD), but it is unclear which approaches can best enhance treatment outcomes. Objectives: To evaluate the comparative effectiveness of 2 psychosocial treatments, peer recovery support (PRS) and cognitive-behavioral therapy (CBT), on opioid abstinence when used as adjunctive therapies to office-based buprenorphine treatment in adults with opioid use disorder (OUD). Design, Setting, and Participants: This randomized clinical trial included US adults diagnosed with OUD referred for care at 5 federally qualified health centers with office-based addiction treatment programs by their clinicians from 2020 to 2024. Participants were followed up for 1 year postenrollment. Analyses were conducted September through November 2025. Interventions: Participants were randomized to 1 of 4 conditions: MOUD treatment as usual, MOUD plus 12 weeks of CBT, MOUD plus 12 weeks of PRS, or MOUD plus 12 weeks of CBT and PRS. The CBT intervention consisted of 12 individual, manualized sessions over 12 weeks focused on goal setting, functional analysis, cognitive restructuring, skill building, and relapse prevention. The PRS intervention required at least once-weekly contact for 12 weeks and focused on shared lived experience, goal setting, and navigation assistance to meet immediate needs. In the CBT plus PRS condition, participants were assigned to 12 weeks of concurrent CBT and PRS. Main Outcome and Measure: The primary outcome was urinalysis-confirmed opioid abstinence at 3, 6, 9, and 12 months. Results: A total of 340 participants were included (mean [SD] age, 42.3 [10.9] years; 100 female [29.4%]). Neither CBT (odds ratio [OR], 1.16; 95% CI, 0.63-2.13), PRS (OR, 0.87; 95% CI, 0.48-1.59), nor their interaction (OR, 0.99; 95% CI, 0.30-3.27) was associated with urinalysis-confirmed opioid use. Conclusions and Relevance: In this randomized clinical trial, CBT and PRS had no effect on rates of opioid abstinence in the year following the initiation of MOUD. Trial Registration: ClinicalTrials.gov Identifier: NCT04257214

Background: The objective of this qualitative study was to better understand the experiences of individuals living with opioid use disorder (OUD) and chronic pain using medical cannabis (MC) for 12 months. Methods: Perspectives were captured via 10 key informant interviews conducted after 12 months of treatment with MC Results: Key themes identified regarding the reasons for initially pursuing MC included: (1) cannabis supply safety; (2) a desire to reduce or eliminate prescription medication usage for pain, OUD and mood; (3) to induce feelings of calm or relaxation; and (4) to improve levels of chronic pain. At 12 months, key themes identified surrounding their lived experiences with MC use were: (1) reductions in pain levels; (2) positive changes in emotional regulation and mood; (3) improvements in sleep quality and duration; and (4) reductions in cravings to use illicit drugs. The primary concerns expressed by interviewees surrounding MC use at 12 months related to changes in weight and appetite, and the cost of MC products. Conclusions: These qualitative data provide targets for future quantitative investigations of the potential mechanisms by which MC can impact recovery in the context of OUD.

Background: Medical cannabis (MC) is approved for the treatment of opioid use disorder (OUD) in Pennsylvania, but little is known about how MC impacts illicit opioid use or the clinical and psychosocial factors including pain severity levels that can precede illicit opioid use. This observational study examined the extent to which changes in rates of illicit opioid use and in pain and psychosocial functioning were observed following the first three months of MC treatment. Methods: A referred sample of 47 adults taking buprenorphine/naloxone for OUD with a minimum pain severity rating of 5/10 enrolled from March 2022–April 2023. Participants were recruited from an outpatient MC physician recommender’s office and were offered a discounted MC 1:1 tetrahydrocannabinol:cannabidiol 5 mg:5 mg daily oral capsule. The primary study outcomes were pain severity, self-efficacy and interference, and the rates of illicit substance use as assessed via urine drug screening (UDS). Results: Participants (64% male, 49% Black, average age = 44 years) reported significant decreases in pain severity from baseline (M = 5.18, SD = 2.09) to Month 3 (M = 4.39, SD = 2.28), P < 0.01, Cohen’s d = 0.54, and pain interference from baseline (M = 5.21, SD = 2.79) to Month 3 (M = 4.32, SD = 2.86), P < 0.01, Cohen’s d = 0.47, and increases in pain-related self-efficacy from baseline (M = 6.55, SD = 3.57) to Month 3 (M = 8.05, SD = 3.30), P < 0.01, Cohen’s d = 0.44. Rates of opioid use (X ²[1] = 4.00, P = 0.13) did not differ significantly from baseline (16%) to Month 3 (5%). Cravings for opioids were mildly higher at baseline (M = 2.15, SD = 2.88) than at 3-months (M = 1.78, SD = 2.95) but this difference was not statistically significant, P = 0.49, d = 0.1. Sleep quality scores improved significantly from baseline (M = 12.38, SD = 4.40) to Month 3 (M = 10.95, SD = 4.95), P < 0.05, d = 0.33. Quality of life significantly improved in seven of eight domains (P < 0.05). Conclusion: MC treatment initiation was associated with reductions in pain severity and interference and improvements in quality of life and sleep quality, but not in illicit opioid use or cravings in adults with chronic pain receiving buprenorphine/naloxone for OUD.

Background: The psychosocial impact of medical marijuana use is not yet known. This study evaluated short-term changes in health-related quality of life (HRQoL) over the first three months of medical marijuana use. Methods: This prospective, observational, longitudinal study followed adults newly recommended for medical marijuana by a physician for any of the more than 20 qualifying medical conditions in Pennsylvania. Participants (N = 438) provided their clinical status and demographic information, and completed semi-structured interviews prior to medical marijuana initiation (baseline) and at three months. HRQoL was assessed by the Short Form-36 (SF-36). Paired-samples t-tests evaluated changes in HRQoL over time. Results: Participants (M age = 46.4 years [15.6]; 66.4% female) were mostly commonly referred for medical marijuana to treat anxiety disorders (61.9%) or severe chronic or intractable pain (53.6%). Participants reported rapid and significant improvements in all of the domains of HRQoL from baseline to three months after initiating medical marijuana use (physical functioning, role limitations due to physical health problems, emotional well-being, role limitations due to emotional problems, bodily pain, social functioning, energy/fatigue and general health, P < .001 for all). Age was negatively predictive of level of improvement over time for the physical functioning (P < .0001), role limitations due to physical health problems (P < .001), and pain (P < .0001) domains after controlling for baseline, with older participants displaying less improvement than younger participants. Conclusions: Gains were observed in all HRQoL domains assessed after three months of medical marijuana use. In several domains, age was a significant predictor of degree of improvement.

Background: Individuals who have substance use disorders may have an elevated risk of suicidality. This study sought to examine the prevalence of, and identify factors associated with, suicidality in adults with opioid use disorder (OUD) initiating office-based buprenorphine treatment. Methods: Individuals were eligible to participate if they had OUD and had initiated treatment in the past month. Participants (n = 244) completed a semi-structured interview using the Addiction Severity Index—Lite. Results: At baseline, 37.70% of participants reported significant thoughts of suicide over their lifetime and 27.46% reported suicidal attempts over their lifetime. Logistic regression analyses were used to identify predictors of lifetime suicidal thoughts and attempts. A history of physical abuse (OR = 4.31, p < .001), having chronic pain-related conditions (OR = 3.28, p < .001), a history of depression (OR = 3.30, p = .001) or anxiety (OR = 7.47, p = .001), and Latino/a/x ethnicity (OR = 2.66, p = .01) were associated with an increased risk of lifetime suicidal thoughts. A history of sexual abuse (OR = 2.89, p = .01), Latino/a/x ethnicity (OR = 4.01, p < .001), a history of depression (OR = 4.03, p = .001) or anxiety (OR = 15.65, p = .007) and having a chronic pain-related condition (OR = 2.43, p = .01), were associated with an increased risk of lifetime suicide attempts. Conclusions: Results demonstrate the high prevalence of suicidal thoughts and attempts among patients initiating buprenorphine. Findings may help to better identify at-risk patients and to inform screening, prevention, and mental health treatment efforts. Trial registration: ClinicalTrials.gov, NCT04650386 (registered 12 December 2020, https://clinicaltrials.gov/ct2/show/NCT04650386) and NCT04257214 (registered 5 February 2020, https://clinicaltrials.gov/ct2/show/NCT04257214).

Objectives: Black, indigenous and people of color (BIPOC) remain underrepresented in research occupations. This report discusses a collaboration to train undergraduate BIPOC students in clinical research between a public health institute, two medical schools, and a historically Black College or University (HBCU). This nine-month program trained BIPOC undergraduates in research methodology, psychology, and addiction science, and immersed trainees in real-world research. The program included didactic seminars, experiential activities, and a mentored research project culminating in a poster and oral presentation. Methods: Key learnings, program satisfaction survey results, and preliminary outcomes from the first three program cohorts (N = 6 students) are presented. This program addressed several barriers hypothesized to contribute to the limited number of BIPOC students pursuing research careers, including mentorship from BIPOC faculty and financial concerns. Results: Students reported moderate to high satisfaction with the program and endorsed gaining new research skills. Limitations and future directions are discussed. Conclusion: The expansion of the BIPOC health and research workforce is an urgent priority given the importance of BIPOC professionals to the health of our nation. Trial registration: ClinicalTrials.gov Identifier: NCT04650386.

Background: We aim to evaluate the association between meal intervals and weight trajectory among adults from a clinical cohort. Methods and Results: This is a multisite prospective cohort study of adults recruited from 3 health systems. Over the 6‐month study period, 547 participants downloaded and used a mobile application to record the timing of meals and sleep for at least 1 day. We obtained information on weight and comorbidities at each outpatient visit from electronic health records for up to 10 years before until 10 months after baseline. We used mixed linear regression to model weight trajectories. Mean age was 51.1 (SD 15.0) years, and body mass index was 30.8 (SD 7.8) kg/m ² ; 77.9% were women, and 77.5% reported White race. Mean interval from first to last meal was 11.5 (2.3) hours and was not associated with weight change. The number of meals per day was positively associated with weight change. The average difference in annual weight change (95% CI) associated with an increase of 1 daily meal was 0.28 kg (0.02–0.53). Conclusions: Number of daily meals was positively associated with weight change over 6 years. Our findings did not support the use of time‐restricted eating as a strategy for long‐term weight loss in a general medical population.

Few studies have evaluated weight change in patients who initiate medical marijuana treatment to address diagnosed health concerns. The objective of this study was to examine whether patients initiating medical marijuana use for a qualifying health condition experienced changes in health and biopsychosocial functioning over time, including weight gain or loss. Specifically, this observational, longitudinal study evaluated changes in the body mass index (BMI) of adults with co-morbid obesity (body mass index [BMI] ≥ 30 kg/m²) and severe obesity (BMI ≥ 40 kg/m²) who were starting medical marijuana treatment for any of the 23 qualifying medical conditions at one of three dispensaries in Pennsylvania. Height and weight measurements were collected at baseline (prior to medical marijuana use) and then 90 days (± 14 days) later. Participants included in analyses (n = 52, M = 55.0 ± 13.6 years, 59.6% female) had a mean baseline BMI of 36.2 ± 5.4 kg/m² and the majority sought medical marijuana for chronic pain (73.1%). No significant change in BMI was observed from baseline to month three (p > 0.05) in the sample. Additionally, no significant change in BMI was observed in the subset of patients with severe obesity (n = 12, p > 0.05). Our findings are limited by low follow-up rates and convenience sampling methodology but may help to mitigate weight gain concerns in the context of medical marijuana use.

Background: To address the obesity epidemic, there is a need for novel paradigms, including those that address the timing of eating and sleep in relation to circadian rhythms. Electronic health records (EHRs) are an efficient way to identify potentially eligible participants for health research studies. Mobile health (mHealth) apps offer available and convenient data collection of health behaviors, such as timing of eating and sleep. Objective: The aim of this descriptive analysis was to report on recruitment, retention, and app use from a 6-month cohort study using a mobile app called Daily24. Methods: Using an EHR query, adult patients from three health care systems in the PaTH clinical research network were identified as potentially eligible, invited electronically to participate, and instructed to download and use the Daily24 mobile app, which focuses on eating and sleep timing. Online surveys were completed at baseline and 4 months. We described app use and identified predictors of app use, defined as 1 or more days of use, versus nonuse and usage categories (ie, immediate, consistent, and sustained) using multivariate regression analyses. Results: Of 70,661 patients who were sent research invitations, 1021 (1.44%) completed electronic consent forms and online baseline surveys; 4 withdrew, leaving a total of 1017 participants in the analytic sample. A total of 53.79% (n=547) of the participants were app users and, of those, 75.3% (n=412), 50.1% (n=274), and 25.4% (n=139) were immediate, consistent, and sustained users, respectively. Median app use was 28 (IQR 7-75) days over 6 months. Younger age, White race, higher educational level, higher income, having no children younger than 18 years, and having used 1 to 5 health apps significantly predicted app use (vs nonuse) in adjusted models. Older age and lower BMI predicted early, consistent, and sustained use. About half (532/1017, 52.31%) of the participants completed the 4-month online surveys. A total of 33.5% (183/547), 29.3% (157/536), and 27.1% (143/527) of app users were still using the app for at least 2 days per month during months 4, 5, and 6 of the study, respectively. Conclusions: EHR recruitment offers an efficient (ie, high reach, low touch, and minimal participant burden) approach to recruiting participants from health care settings into mHealth research. Efforts to recruit and retain less engaged subgroups are needed to collect more generalizable data. Additionally, future app iterations should include more evidence-based features to increase participant use.

Introduction: Despite the rising availability and use of medical marijuana (MM) in the USA, little is known about the demographics, clinical characteristics, or quality of life of MM patients. This study describes the demographic characteristics and health-related quality of life (HRQoL) of MM patients who are initiating treatment in Pennsylvania. Methods: Two-hundred adults naive to MM and referred for any of the 23 state-approved qualifying conditions were recruited at three MM dispensaries in Pennsylvania between September 2020 and March 2021. All participants consented to the study; completed semi-structured interviews that included demographic questionnaires, the Short Form-36 (SF-36), and Generalized Anxiety Disorder-7 (GAD-7); provided height and weight measurements; and allowed access their dispensary medical records. Results: Participants had a mean age of 48.5 ± 15.6 years, predominantly identified as female (67.5%), and were most commonly referred for chronic pain (63.5%) and/or anxiety (58.5%). Additionally, 46.0% were living with obesity as determined by BMI. Relative to a normative sample, participants reported diminished HRQoL in several domains, most notably in role limitations due to physical health (M = 46.0 ± 42.0), role limitations due to emotional problems (M = 52.5 ± 42.3), energy and fatigue (M = 39.8 ± 20.2), and pain (M = 49.4 ± 26.0). Discussion/Conclusion: Patients initiating MM treatment experienced low HRQoL in multiple domains. Future studies could evaluate the relationship between HRQoL and patients’ decisions to pursue MM treatment, as well as changes in HRQoL with MM use over time.