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ABSTRACT IMPACT: The model of the Clinical Research Support Center at the University of Minnesota of streamlining clinical trial infrastructure can be leveraged by the larger clinical trial community to create valuable efficiencies and facilitate faster initiation of research activities by supporting researchers from concept to dissemination. OBJECTIVES/GOALS: Substantial time, energy, and money are spent bridging disparate resources in research. We describe how the University of Minnesota’s (UMN) Clinical Research Support Center (CRSC) streamlines trial infrastructure, creating valuable efficiencies to support researchers from concept to dissemination. METHODS/STUDY POPULATION: The CRSC, established in 2018 through the Clinical and Translational Science Award (CTSA) program, brings resources together in a single, centralized, and convenient location to help researchers navigate the UMN clinical research startup process and specifically to assist with the development and initiation of a research study from feasibility assessment to project opening. Diverse expertise in components of human subject research is available to support the broad scope of projects at a large institution like the UMN. We present how CRSC services, when coordinated by Clinical Research Specialists, have been used to improve access to clinical research resources during the start up process. RESULTS/ANTICIPATED RESULTS: Since inception in 2018, the CRSC has provided support to over 1700 studies with 437 research projects referred to a Clinical Research Specialist within the CRSC. Of those projects, 97 (22.2%) received comprehensive support from the following expert groups: regulatory guidance (n=74), biostatistics (n=68), clinical (hospital or clinic) partners (n=60), recruitment (n=36), budget development assistance (n=30), and (bio)informatics (n=27). Successful examples of synergies to streamlining study start up include shortening the window between protocol development support from Clinical Research Specialists and IRB submission preparation through to Regulatory Specialists to 3 days. DISCUSSION/SIGNIFICANCE OF FINDINGS: Providing cross-functional support to research teams through the CRSC increases the likelihood of quicker and successful execution and completion of research initiation and subsequently impacts the dissemination of that research to patients and the broader community.
ABSTRACT IMPACT: In a global pandemic where data development and dissemination are integral to combating the disease, the Clinical Research Support Center at the University of Minnesota provides a model of comprehensive virtual support, helping to attain and disseminate novel research on COVID-19, its individual and community impact, and treatment initiatives/outcomes. OBJECTIVES/GOALS: The pandemic created massive disruption to the conduct of clinical research with an unprecedented reorientation towards COVID-19. In this fast-paced environment, the Clinical Research Support Center (CRSC) rapidly developed innovative means of supporting diverse research initiatives. METHODS/STUDY POPULATION: The CRSC rapidly transitioned into a virtual environment and developed tools for the clinical research community to enhance remote clinical trial start up. This includes supporting remote consent, eBinders, COVID-19 research training for clinical staff, and easier identification of potential participants for COVID-19 studies; all through virtual support. Support provided research teams guidance on study protocols, regulatory requirements, informatics, biostatistics, financial management, recruitment strategies to support critical, urgent COVID-19 research. We outline proactive examples of how the CRSC now provides support to research teams through the pandemic. RESULTS/ANTICIPATED RESULTS: From March-November 2020, 116 COVID-19 projects received virtual support from the CRSC for COVID-19 research: disease understanding (n=27), treatment (n=23), pandemic impact (n=20), clinical care innovation (n=18), disease control and surveillance (n=10), prevention (n=9), detection (n=5), and impact on minorities (n=4). The diversity of these studies demonstrates the demand for and benefit from multidisciplinary expertise supporting study design and implementation. Through successful articulation and acceleration of research activities, the CRSC met the need for speed and rapidly adapted to new challenges created by the pandemic. DISCUSSION/SIGNIFICANCE OF FINDINGS: In a global pandemic where rapidly changing barriers to research is ongoing, through multidisciplinary efforts, the CRSC continues to provide comprehensive, virtual support to attain and disseminate novel research on COVID-19, its individual and community impact, and treatment initiatives/outcomes.
Gambling disorder is a relatively common psychiatric disorder recently re-classified within the DSM-5 under the category of ‘substance-related and addictive disorders'.
To compare white matter integrity in patients with gambling disorder with healthy controls; to explore relationships between white matter integrity and disease severity in gambling disorder.
In total, 16 participants with treatment-resistant gambling disorder and 15 healthy controls underwent magnetic resonance imaging (MRI). White matter integrity was analysed using tract-based spatial statistics.
Gambling disorder was associated with reduced fractional anisotropy in the corpus callosum and superior longitudinal fasciculus. Fractional anisotropy in distributed white matter tracts elsewhere correlated positively with disease severity.
Reduced corpus callosum fractional anisotropy is suggestive of disorganised/damaged tracts in patients with gambling disorder, and this may represent a trait/vulnerability marker for the disorder. Future research should explore these measures in a larger sample, ideally incorporating a range of imaging markers (for example functional MRI) and enrolling unaffected first-degree relatives of patients.
Excoriation (skin-picking) disorder (SPD) is a relatively common
psychiatric condition whose neurobiological basis is unknown.
To probe the function of fronto-striatal circuitry in SPD.
Eighteen participants with SPD and 15 matched healthy controls undertook
an executive planning task (Tower of London) during functional magnetic
resonance imaging (fMRI). Activation during planning was compared between
groups using region of interest and whole-brain permutation cluster
The SPD group exhibited significant functional underactivation in a
cluster encompassing bilateral dorsal striatum (maximal in right
caudate), bilateral anterior cingulate and right medial frontal regions.
These abnormalities were, for the most part, outside the dorsal planning
network typically activated by executive planning tasks.
Abnormalities of neural regions involved in habit formation, action
monitoring and inhibition appear involved in the pathophysiology of SPD.
Implications exist for understanding the basis of excessive grooming and
the relationship of SPD with putative obsessive–compulsive spectrum
Pathological gambling is a disabling disorder experienced by about 1% of adults. We randomised 233 participants (41.6% women) 1:1:1 to nalmefene (20 or 40 mg) or placebo. In analyses performed using an intention-to-treat (ITT) population, nalmefene failed to show statistically significant differences from placebo on primary and secondary outcomes. Post hoc analyses of only participants who received a full titration of the medication for at least 1 week demonstrated that nalmefene 40 mg/day resulted in significantly greater reductions on the primary outcome measure. These findings suggest that medication dosing may be an important consideration in achieving symptom control.
Pathological gambling (PG) is distinguished in both Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and the tenth edition of the International Classification of Mental and Behavioral Disorders (ICD-10) from gambling secondary to mania and from social gambling, which does not persist when adverse events occur. It may be associated with dopamine agonist treatments for Parkinson's disease. PG is also associated with greater health problems and increased use of medical services. Although cognitive-behavioral therapy (CBT), opioid antagonists, and sustained-release lithium carbonate appear promising for the treatment of PG, several limitations affect the current body of knowledge. PG is a common disabling psychiatric disorder associated with high rate of co-occurring disorders, particularly substance use disorders, and high rate of social and occupational dysfunction. Although psychotherapies and pharmacotherapies have shown promise, the limited data preclude making treatment recommendations with substantial degree of confidence.
Sixty-eight individuals were randomised to either six sessions of imaginal
desensitisation plus motivational interviewing (IDMI) or Gamblers Anonymous.
Individuals assigned to IDMI had significantly greater reductions in
Yale–Brown Obsessive Compulsive Scale Modified for Pathological Gambling
total scores, gambling urges and gambling behaviour. People who failed to
respond to Gamblers Anonymous reported significantly greater reduction in
pathological gambling symptoms following later assignment to IDMI.
Abstinence was achieved by 63.6% during the acute IDMI treatment period.
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