Feasibility pilot of a novel coaching intervention to optimize cannabis use for chronic pain management among Veterans.

Introduction: Chronic pain is common among Veterans, some of whom use cannabis for pain. We conducted a feasibility pilot study of a novel coaching intervention to help Veterans optimize use of medical cannabis products for pain management (NCT06320470).

Methods: The intervention drew from scientific literature, consultation with cannabis experts, Veteran input via a Community Advisory Board, and tenets of motivational interviewing.

Bayesian Sample Size Calculation in Small n, Sequential Multiple Assignment Randomized Trials (snSMART).

A recent study design for clinical trials with small sample sizes is the small n, sequential, multiple assignment, randomized trial (snSMART). An snSMART design has been previously proposed to compare the efficacy of two dose levels versus placebo. In such a trial, participants are initially randomized to receive either low dose, high dose or placebo in stage 1.

Self-acupressure for patients with breast cancer experiencing aromatase inhibitor-associated musculoskeletal symptoms: Protocol for the AcuAIM randomized pilot trial.

Background: Aromatase inhibitors (AI) reduce hormone receptor-positive breast cancer recurrence risk by about 50%. However, half of AI-treated postmenopausal women report new or worsened musculoskeletal symptoms (AIMSS), and 20% discontinue therapy prematurely. Acupuncture is effective for reducing symptoms, but many women are not able to access acupuncture therapy.

The use of sequential multiple assignment randomized trials (SMARTs) in physical activity interventions: a systematic review.

Background: Physical activity (PA) is often the cornerstone in risk-reduction interventions for the prevention and treatment of many chronic health conditions. PA interventions are inherently multi-dimensional and complex in nature. Thus, study designs used in the evaluation of PA interventions must be adaptive to intervention components and individual capacities.

Prevalence of Tobacco and Poly-Tobacco Use as a Function of Sexual Orientation Identity and Sex.

Introduction: Limited research has characterized poly-tobacco use (i.e., use of at least two nicotine/tobacco products) among adults with sexual minoritized (SM) identities (i.

A meta-analytic review of cognitive behavior therapy and motivational interviewing for adolescent and young adult sleep concerns.

Cognitive behavioral therapy (CBT) is an evidenced-based treatment for sleep concerns but may be insufficient on its own to resolve adolescent sleep problems - combining this treatment with motivational interviewing may result in more robust improvements to sleep in adolescents and young adults (AYA). This study aimed to conduct the first meta-analysis of integrated CBT and motivational interviewing (MI) for AYA sleep concerns. Following PRISMA guidelines, PsycINFO, PubMed, and Google Scholar were searched through January 2024.

A Partially Randomized Patient Preference, Sequential, Multiple-Assignment, Randomized Trial Design Analyzed via Weighted and Replicated Frequentist and Bayesian Methods.

Results from randomized control trials (RCTs) may not be representative when individuals refuse to be randomized or are excluded for having a preference for which treatment they receive. If trial designs do not allow for participant treatment preferences, trials can suffer in accrual, adherence, retention, and external validity of results. Thus, there is interest surrounding clinical trial designs that incorporate participant treatment preferences.

Study protocol for a sequential multiple assignment randomized trial to decrease alcohol use before and after surgery.

Background: High-risk alcohol consumption in the weeks before and after surgery poses significant risks for postoperative recovery. Despite this, elective surgical patients are rarely offered alcohol-focused education, interventions, or treatment. This paper describes the protocol of a research study designed to evaluate the effectiveness of brief, non-pharmacological, therapeutic approaches to reduce alcohol use before and after surgery.

A sequential, multiple assignment, randomized trial design with a tailoring function.

We present a trial design for sequential multiple assignment randomized trials (SMARTs) that use a tailoring function instead of a binary tailoring variable allowing for simultaneous development of the tailoring variable and estimation of dynamic treatment regimens (DTRs). We apply methods for developing DTRs from observational data: tree-based regression learning and Q-learning. We compare this to a balanced randomized SMART with equal re-randomization probabilities and a typical SMART design where re-randomization depends on a binary tailoring variable and DTRs are analyzed with weighted and replicated regression.

Emotional Eating Prevalence and Correlates in Adolescents in the United States.

Adolescent obesity rates continue to rise. A better understanding of who engages in emotional eating, a maladaptive eating style, is needed. Despite emotional eating being a frequent research target, the prevalence of emotional eating in US adolescents is currently unknown.

Protocol for a pragmatic trial of Cannabidiol (CBD) to improve chronic pain symptoms among United States Veterans.

Background: Chronic pain affects over 100 million Americans, with a disproportionately high number being Veterans. Chronic pain is often difficult to treat and responds variably to medications, with many providing minimal relief or having adverse side effects that preclude use. Cannabidiol (CBD) has emerged as a potential treatment for chronic pain, yet research in this area remains limited, with few studies examining CBD's analgesic potential.

Attention-deficit/hyperactivity symptoms and loss of control eating in emerging adults: Role of psychological resilience.

Objective: This study aimed to fill a gap in the literature regarding the role of resilience in the relationship between symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) and loss of control (LOC) eating in a nonclinical sample of emerging adults. Resilience was examined as a potential moderator and as a potential mediator of ADHD symptoms and engagement in LOC eating behaviors. Improved understanding of this relationship may inform clinical intervention and risk screening methodologies for disordered eating behaviors in college students.

Engagement in mHealth-Prompted Self-Measured Blood Pressure Monitoring Among Participants Recruited From a Safety-Net Emergency Department: Secondary Analysis of the Reach Out Trial.

Background: Hypertension, a key modifiable risk factor for cardiovascular disease, is more prevalent among Black and low-income individuals. To address this health disparity, leveraging safety-net emergency departments for scalable mobile health (mHealth) interventions, specifically using text messaging for self-measured blood pressure (SMBP) monitoring, presents a promising strategy. This study investigates patterns of engagement, associated factors, and the impact of engagement on lowering blood pressure (BP) in an underserved population.

Hospital Associated Disability among Older Adults with Plasma Cell Disorders Receiving Autologous Stem Cell Transplant.

Increasing number of older adults with Plasma Cell Disorders (PCDs) are receiving autologous stem cell transplant (ASCT) in the US. Hospital associated disability (HAD) is a common complication associated with acute care hospitalization among older adults. To estimate the prevalence and prognostic significance of HAD among older adults with MM undergoing ASCT.

Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement.

Most patients with alcohol-associated liver disease (ALD) engage in heavy drinking defined as 4 or more drinks per day (56 g) or 8 (112 g) or more drinks per week for women and 5 or more drinks per day (70 g) or 15 (210 g) or more drinks per week for men. Although abstinence from alcohol after diagnosis of ALD improves life expectancy and reduces the risk of decompensation of liver disease, few studies have evaluated whether treatment of alcohol use disorders will reduce progression of liver disease and improve liver-related outcomes. In November 2021, the National Institute of Alcohol Abuse and Alcoholism commissioned a task force that included hepatologists, addiction medicine specialists, statisticians, clinical trialists and members of regulatory agencies to develop recommendations for the design and conduct of clinical trials to evaluate the effect of alcohol use, particularly treatment to reduce or eliminate alcohol use in patients with ALD.

Feasibility and acceptability of patient- and clinician-level antithrombotic stewardship interventions to reduce gastrointestinal bleeding risk in patients using warfarin (Anticoagulation with Enhanced Gastrointestinal Safety): a factorial randomized controlled pilot trial.

Background: Overuse of antiplatelet therapy and underuse of gastroprotection contribute to preventable bleeding in patients taking anticoagulants.

Objectives: (1) Determine the feasibility of a factorial trial testing patient activation and clinician outreach to reduce gastrointestinal (GI) bleeding risk in patients prescribed warfarin-antiplatelet therapy without proton pump inhibitor gastroprotection and (2) assess intervention acceptability.

Methods: Pragmatic 2 × 2 factorial cluster-randomized controlled pilot comparing (1) a patient activation booklet vs usual care and (2) clinician notification vs clinician notification plus nurse facilitation was performed.

Polypharmacy, over-the-counter medications, and aromatase inhibitor adherence in early-stage breast cancer.

Purpose: Polypharmacy is associated with negative health outcomes and decreased medication adherence. Polypharmacy is common in cancer populations, but few studies have evaluated the relationship between polypharmacy and aromatase inhibitor (AI) adherence. No studies have evaluated the relationship between over-the-counter (OTC) supplements and AI adherence.

Feasibility of Electronic Medication Monitoring Among Adolescents and Emerging Adults with Sickle Cell Disease.

Purpose: To examine the feasibility of using MEMS bottles to assess adherence among adolescents and emerging adults with sickle cell disease.

Patients And Methods: Eighteen non-Hispanic Black participants with HbSS (M = 17.8 years; 61% male) were given a MEMS bottle to store hydroxyurea (n = 14) or deferasirox (n = 4).

Improving alcohol treatment engagement using integrated behavioral interventions in alcohol-associated liver disease: A randomized pilot trial.

Introduction: Alcohol cessation improves mortality in alcohol-associated liver disease (ALD), but few ALD patients will engage in treatment. We aimed to demonstrate the feasibility and acceptability of a mobile health intervention to increase alcohol use disorder (AUD) treatment among ALD patients.

Methods: We conducted a pilot randomized controlled trial (September 2020 to June 2022) at a single tertiary care center in adults with any stage of ALD, past 6-month drinking, and no past-month AUD treatment.

Effects of and genotype on systemic anastrozole and fulvestrant concentrations in SWOG S0226.

This study tested associations of genotype-predicted activity of CYP3A4, other pharmacogenes, (rs11648166) and (rs28845026) with systemic concentrations of the endocrine therapies anastrozole and fulvestrant in SWOG S0226 trial participants. Participants in the anastrozole-only arm with low CYP3A4 activity (i.e.

Dynamic enrichment of Bayesian small-sample, sequential, multiple assignment randomized trial design using natural history data: a case study from Duchenne muscular dystrophy.

In Duchenne muscular dystrophy (DMD) and other rare diseases, recruiting patients into clinical trials is challenging. Additionally, assigning patients to long-term, multi-year placebo arms raises ethical and trial retention concerns. This poses a significant challenge to the traditional sequential drug development paradigm.

Reach Out Emergency Department: A Randomized Factorial Trial to Determine the Optimal Mobile Health Components to Reduce Blood Pressure.

Background: Mobile health (mHealth) strategies initiated in safety-net Emergency Departments may be one approach to address the US hypertension epidemic, but the optimal mHealth components or dose are unknown.

Methods: Reach Out is an mHealth, health theory-based, 2×2×2 factorial trial among hypertensive patients evaluated in a safety-net Emergency Department in Flint, Michigan. Reach Out consisted of 3 mHealth components, each with 2 doses: (1) healthy behavior text messaging (yes versus no), (2) prompted self-measured blood pressure (BP) monitoring and feedback (weekly versus daily), and (3) facilitated primary care provider appointment scheduling and transportation (yes versus no).