STAT+: FDA adcomm members’ ties to industry under scrutiny

Good morning. Yesterday, we got the devastating news that STAT’s infectious disease correspondent, Helen Branswell, passed away. She was a reporter I always looked up to and was also an incredibly generous colleague. Please take the time to read this tribute to her.

The need-to-know this morning

  • Liquidia and United Therapeutics reached a settlement agreement that resolves their ongoing patent litigation over Liquidia’s treatment for pulmonary arterial hypertension. 

New trial to test effect of GLP-1s on social outcomes

Researchers in Pittsburgh are launching a novel type of GLP-1 trial — testing not only if the drug will help people with addiction, but also if it will help reduce recidivism while improving other employment, health, and housing outcomes.

The Center for Addiction Science, Policy and Research (CASPR), a non-profit organizing the effort, and the Allegheny County Department of Human Services are planning to launch the trial in early 2027. They will enroll up to 1,200 adults with alcohol use disorder, opioid use disorder, or both, who are also at high risk of criminal-justice involvement. Half will be randomly assigned to take Novo Nordisk’s Wegovy, according to a press release issued yesterday.

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A comparison of recovery benefits associated with participation in SMART Recovery, AA, both SMART and AA, or neither, following a new alcohol use disorder recovery attempt

BackgroundSelf-Management and Recovery Training (SMART Recovery or “SMART”) is an internationally known “second-wave” addiction recovery mutual-help organization that has grown over several decades. Despite this, little is known empirically about who uses SMART and how they fare on important alcohol-specific outcomes over time relative to individuals using more established options such as Alcoholics Anonymous (AA), or indeed those who utilize both SMART and AA, or neither. Greater knowledge could deepen understanding of the clinical and public utility of SMART in its own right and inform clinical referral options.MethodsA naturalistic, longitudinal cohort study (N = 361) of individuals recruited between February 2019 and February 2022 who were initiating a new alcohol use disorder (AUD) recovery attempt and self-selected into one of four groups at study entry: (1) SMART Recovery; (2) AA; (3) SMART + AA; and (4) neither SMART nor AA. Assessments were conducted at intake, 3 months, and 6 months and measured a variety of alcohol/drug-related and functioning outcomes.ResultsCompared to the AA and Both groups, SMART Recovery pathway participants exhibited a pattern of less severe clinical pathology and legal system involvement histories, along with higher psychosocial stability and recovery capital. In terms of meeting attendance frequency, the SMART group did not attend as many meetings as the AA or Both groups, but nevertheless was able to achieve levels of improvement in alcohol indicators (i.e., fewer drinking days, fewer heavy drinking days, and fewer alcohol-related consequences) and rates of early AUD remission similar to those of the AA and Both groups.ConclusionsSMART Recovery may provide a valuable alternative source of recovery-specific support that may be a good fit, particularly for certain individuals with AUD. As such, it serves as a valuable addition to the menu of available community-based recovery-support service options.

Access to addiction meds for young people has improved — but retention hasn’t

In 2016, the American Academy of Pediatrics issued a policy statement urging doctors to offer medications for opioid use disorder to adolescent and young adult patients who needed them.  

New national data show that more young people with an opioid use disorder diagnosis did start receiving addiction medications like buprenorphine and methadone, but the increase was small. And the number of young people who stayed on medication for six months — already quite low — may have actually decreased. 

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Kratom and 7-OH should be regulated, experts agree. They’re split on how

Kratom leaf products, often used to ease chronic pain, anxiety, or withdrawal from opioids, have been sold in the U.S. for decades, largely skirting any regulatory restrictions despite a known risk for physical dependence. But increasingly, Americans are turning to newer, more potent products made with a semi-synthetic kratom derivative, 7-hydroxymitragynine, or 7-OH. 

Clinicians and recovery advocates warn that highly-concentrated 7-OH could be even more addictive than kratom, though research is scarce. Most people agree that some sort of guardrails need to be put into place. They disagree, however, on what those regulations should be.

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Acceptability and Feasibility of a Virtual Family-Based Single-Session Intervention for Young Teens at High Risk for Substance Use Disorder: Single-Arm Pilot Trial

<strong>Background:</strong> Preventive interventions to delay substance use disorder (SUD) are ideally delivered during early adolescence, a critical period for exposure to substance use (SU) risk factors. Young teens (aged 12-14 years) engaging in occasional use of alcohol, cannabis, or tobacco use, or with a family history of SUD, are at increased risk for SUD. Although behavioral-ecological family therapy is effective for prevention, many families face access barriers. Single-session interventions (SSIs) may offer an accessible, low-intensity alternative. <strong>Objective:</strong> This open pilot trial aimed to evaluate the acceptability, feasibility, and potential usefulness of a family-based SSI targeting improvements in family practices that prevent SUD. <strong>Methods:</strong> Participants were 9 young teens engaging in occasional SU or with a family history of SUD and their parent. The SSI involved a virtual 2-hour family consultation with a trained family coach. Acceptability was measured via Program Feedback Scale, feasibility via SSI completion rate, and potential usefulness via pre-post changes in parenting self-efficacy. <strong>Results:</strong> The SSI was acceptable to parents and teens (mean Program Feedback Scale scores ≥3) and feasible (8/9, 88.89% of parent-teen dyads completed the SSI). Among the 8 completing dyads, most participants (13/16, 81.25%) selected Communication and Problem Solving as their primary target for change. Parents reported increases in parenting self-efficacy from pre- to post-SSI. <strong>Conclusions:</strong> Findings support the SSI’s acceptability and feasibility for young teens at high risk for SUD. A randomized clinical trial is needed to confirm the SSI’s acceptability, feasibility, and efficacy, as well as to address potential for delivery by a lay workforce. <strong>Trial Registration:</strong> ClinicalTrials.gov NCT06538922; https://clinicaltrials.gov/study/NCT06538922

Smartphone addiction, physical activity engagement, and sleep quality in Chinese adolescents: a parallel and serial mediation model

IntroductionExcessive smartphone use has become a major public health concern among adolescents, particularly in China where smartphone use is widespread. Although smartphone addiction is consistently associated with poor sleep quality, the mechanisms underlying this association remain insufficiently understood. This study examined whether physical activity engagement and depressive symptoms operate as parallel and serial mediators linking smartphone addiction to sleep quality in Chinese adolescents.MethodsA cross-sectional survey was conducted among 612 adolescents (Mage = 14.2 years, SD = 1.6; 51.3% female) from four secondary schools in Hubei Province, China. Participants completed the Smartphone Addiction Scale–Short Version, the Physical Activity Questionnaire for Adolescents, the Pittsburgh Sleep Quality Index, and the Depression subscale of the Depression Anxiety Stress Scales-21. Path analysis of observed composite scores with robust maximum likelihood estimation and bias-corrected bootstrapping (5,000 resamples) was used to test the proposed parallel and serial mediation model.ResultsSmartphone addiction was positively associated with poor sleep quality (β = .38, p <.001). Both physical activity (indirect effect = .04, 95% CI [.01,.07]) and depressive symptoms (indirect effect = .14, 95% CI [.09,.19]) significantly mediated this association in parallel. In addition, the serial pathway from smartphone addiction to low physical activity, elevated depressive symptoms, and poor sleep quality was significant (indirect effect = .02, 95% CI [.01,.04]). The mediators collectively accounted for 52.6% of the total effect.DiscussionThese findings suggest that problematic smartphone use is associated with poorer adolescent sleep through behavioral and psychological pathways involving reduced physical activity and elevated depressive symptoms. School-based interventions that promote physical activity while reducing problematic smartphone use may help protect adolescent sleep and mental health. Longitudinal and experimental designs are needed to establish causal direction and inform intervention development.

Trait, state, and behavior in adolescent NSSI addiction: a serial mediation model linking childhood trauma to NSSI addiction

BackgroundDespite growing recognition of non-suicidal self-injury (NSSI) as a potential behavioral addiction, the sequential mechanisms linking childhood trauma to NSSI addiction remain unclear. This study examined a serial mediation model testing whether trait impulsivity and depressive symptoms sequentially mediate this relationship, with NSSI function as a behavioral coping mechanism.MethodsThis cross-sectional study included 163 Chinese adolescents diagnosed with major depressive disorder and a history of NSSI. Participants completed the Childhood Trauma Questionnaire-Short Form, the Short UPPS-P Impulsive Behavior Scale, the Children’s Depression Inventory, and the Ottawa Self-Injury Inventory (Functions and Addictive Features subscales). Serial mediation analysis (PROCESS Model 6, 5,000 bootstrap resamples), controlling for demographic and clinical covariates, tested the hypothesized five-step sequential model.ResultsChildhood trauma was positively associated with NSSI addiction, and this association was predominantly mediated: the total indirect effect accounted for 56.2% of the total effect. Indirect effects involving NSSI function in combination with upstream mediators were significant, including the full sequential path (B = 0.0033, 95% CI [0.0007, 0.0083]), whereas simple mediations via impulsivity, depression, or NSSI function alone were not.ConclusionThese findings support a trait-state-behavior-addiction cascade in which childhood trauma is associated with trait impulsivity and depressive symptoms that, in combination with the reinforcing function of NSSI, are linked to addictive features of NSSI. The model advances theoretical understanding of NSSI addiction and offers actionable clinical targets for prevention and intervention. Longitudinal studies are needed to confirm causal directions.

Adolescent non-suicidal self-injury scale – short form: revision and evaluation of its reliability and validity

ObjectiveNon-suicidal self-injury (NSSI) is a clinically significant concern among adolescents, and its accurate yet efficient assessment is essential for research, early identification, and intervention. Existing Chinese instruments—most notably the 19-item Adolescent Self-Harm Questionnaire (ASHS)—are relatively lengthy and ill-suited to rapid, large-scale screening. The present study had two aims: (a) to develop a short form of the ASHS, the Adolescent Non-Suicidal Self-Injury Scale–Short Form (ANSSI-SF), by integrating classical test theory (CTT) item analysis with genetic algorithm (GA) cross-validation, and (b) to evaluate its reliability, validity, and screening utility relative to the parent scale.MethodsUsing a convenience sample of 1,090 primary and secondary school students, seven items—one for each of seven behavioral categories derived from a functional–typological framework of self-harm—were selected on the basis of CTT item statistics and GA cross-validation. The scale was evaluated through item analysis, internal-consistency and split-half reliability, exploratory and confirmatory factor analysis (EFA/CFA), correlations with theoretically related constructs, known-groups comparisons (gender; smartphone addiction), and consistency and screening-accuracy analyses against the full 19-item ASHS.ResultsIt indicated that all items demonstrated strong correlations with the total score, and both internal consistency and split-half reliability reached satisfactory levels.A unidimensional factor structure also exhibited good model fit. Additionally, scale scores were significantly positively correlated with related psychological indicators such as depression, anxiety, and sleep problems, and effectively differentiated differences in self-injurious behavior across gender and smartphone addiction groups.GA cross-validation confirmed that the selected items balanced parsimony with full coverage of all seven behavioral categories.DiscussionThese findings indicate that the ANSSI-SF is a brief, reliable, and valid instrument that preserves the content breadth of the parent ASHS while substantially reducing administration burden. It is well suited to rapid, large-scale screening and early identification of at-risk adolescents, facilitating timely referral and prevention. Limitations include convenience sampling from a single region and the absence of test–retest reliability; future research should validate the scale in clinical and diverse cultural samples and examine its predictive validity.