89 Clinical Trials for Various Conditions
Current providers' standard operating procedures on pharmacogenomic testing patients
This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform medication prescription in subjects with a primary diagnosis of depression with comorbidity of non-psychotic behavioral disorders versus treatment as usual, as determined by the investigator. The primary measurement for improvement of the subjects depression will be a self-evaluation questionnaire, the Quick Inventory of Depressive Symptomatology-Self Report 16 , but the investigators will also collect information on their clinical global improvement and any reduction in adverse events.
The purpose of the study is to determine if opioid disposal bags/pouches are an effective method for disposing of unused opioid medications postoperatively
The objective of this investigation is to pilot test a medication in-hand intervention (Meds to Beds) compared to standard care for patients with heart failure (ICD-50\[all numbers\]). The study will evaluate if the intervention improves adherence and physical health, and reduces hospital re-admissions. The study will provide evidence for the feasibility and acceptability of the medication-in-hand intervention.
The purpose of this study is to determine whether seeing a physical therapist first compared with seeing a physician first is more clinically and cost effective in an occupational setting for acute musculoskeletal conditions.
The overall objective of the proposed pilot study is to begin evaluation of two methods for promoting adherence to guidelines for beta-blocker therapy in heart failure. The design includes site level baseline measurement, feedback, remeasurement after six months, and randomized (by site) comparison samples. The setting is VA sites, with intervention directed at the pharmacy.
This goal of this observational study is to develop and test the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool. The tool will be an opioid medication risk screener and decision support platform that will be used by pharmacists upon dispensing prescription opioid medication. Once the Opioid Risk Reduction has been developed, we will examine the impact of the ORRCDS within two divisions of a large chain retail pharmacy. Pharmacies will be randomized to using the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool or standard of care opioid dispensation. We hypothesize that patients at pharmacies randomized to the ORRCDS tool will be more likely to reduce their risk status to low or moderate compared to the patients at standard of care pharmacies.
The goal of this study is to validate the TAPS-ESP as a screen and assessment that can be used in primary care for the screening and treatment of substance use.
The objective of this study is to evaluate the impact of the value-based formulary on patient out-of-pocket spending and health plan spending as well as the impact of the value-based formulary on medication use, emergency department visits, hospitalizations, and outpatient office visits.
This study will examine the effects of doses of opioid/placebo and doses of sedative/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.
The goal of the study is to validate a Prescription Drug Monitoring Program-based opioid risk metric to discriminate between low, moderate, and high-risk opioid use disorder. The World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST) will be used as the gold standard instrument that defines patient risk levels. No intervention or hypothesis will be tested.
This Phase 1 STTR project will develop a technology platform for delivering the TAPS Tool to a Spanish-speaking, health disparity population in a community health center. This will involve the adaptation of the TAPS into Spanish, its deployment on a self-administered mobile/tablet technology platform, and an empirical study of its preliminary validity, feasibility, and acceptability in a Spanish-speaking primary care sample. The investigators refer to this novel adaptation of the TAPS Tool as the TAPS-Electronic Spanish Platform, or TAPS-ESP.
The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.
Our overall objective is to assess the value of Spinal Manipulation Services as compared to Prescription Drug Therapy for long-term management of chronic Law back Pain (LBP). Our central hypothesis is that among aged Medicare beneficiaries with chronic LBP, utilization of SMS offers superior value (to both patient and payer) for long-term care as compared to PDT.
This project will develop and evaluate a program to prevent prescription drug abuse in high school students
The aims of this pilot study are: (1) to assess the feasibility and acceptability of a mobile application to educate military members about the risks of prescription drug misuse; (2) to determine if there is evidence that the mobile application plus treatment as usual reduces the risk of prescription drug misuse and shows differences in related measures compared to treatment as usual among military medical clinic patients currently taking prescription medication; and (3) if evidence of reduced risk is found, to estimate effect sizes for a future effectiveness trial. The pilot study will use a randomized controlled design with two groups. The control group will be provided with treatment as usual (TAU), and the experimental group will be provided with the prescription drug-abuse educational smartphone application in addition to treatment as usual (app + TAU). Self-reported measures of risk of misuse and related attitudes and knowledge will be administered to all participants at baseline, 1 month, and 3 months. The mobile app is a brief intervention designed to help military members to assess their risk for medication misuse and provide individualized feedback on risk level with recommendations for reducing risk. The app also contains other features, including sections in which to store information on current medications and look up drug interactions and provides resources for help.
The Harnessing Online Peer Education (HOPE) intervention combines social media with a psychology-based interventions to change behavior. This intervention is being applied to reduce prescription drug abuse among patients with chronic pain.
Brandeis University and University of South Carolina (USC) have joined together to develop the South Carolina Opioid Safety Initiative - Military (SCOSI-M), to develop an academic detailing (medical education) intervention for physicians and evaluate its effectiveness in a pilot study. The goal of the intervention is to increase the use of safe prescribing and prescription monitoring practices among primary care physicians. The research team will design and pilot an educational intervention for physicians who treat military personnel, veterans, and their families with prescription opioids. The overall aim of SCOSI-M is to prevent the onset or progression of prescription drug problems among Iraq and Afghanistan veterans, military members, and their families who are at high risk for developing problems if their treatment involves long-term use of an opioid.
The purpose of the study is to develop and validate a questionnaire to screen and assess adult primary care patients for tobacco, alcohol, prescription drug, and drug use and problems related to their use.
The goal of this project is to understand the effects of receiving peer information on individuals' conversion rates from brand name prescription medication to generic prescription medication.
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).
The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve patients' understanding of instructions for use. The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve patients' understanding of actual prescribed medicines, compared to a standard label format. Patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive their prescribed medicines from this location. Recruited subjects in this study will be randomly assigned to either intervention (enhanced Rx container label) or control (standard Rx label). All pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. Study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). Pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label instructions, including auxiliary warnings, will be the primary outcomes. Other exploratory outcome measures will also be measured, including 1) adverse effects associated with medication use defined by a) the rate of physician visits, b) the rate of emergency room visits, and c) the rate of hospitalizations and hospital admissions via emergency rooms for medication side effects (e.g. hyperglycemia or hypoglycemia); and 2) health outcome as measured by the change from baseline in hemoglobin A1c (HbA1c) and blood pressure measurements. Data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study.
The purpose of this study is to determine whether physicians can be educated to better handle inappropriate requests from patients for direct-to-consumer advertised prescription medications.
Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function during brief periods of abstinence.
A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether dronabinol can reduce withdrawal effects associated with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked marijuana, and whether there are any cognitive performance deficits associated with dronabinol doses that produce such effects.
Prior studies have documented a high prevalence of patients misunderstanding prescription drug warning labels, placing them at risk for medication error. We sought to evaluate the effectiveness of 'enhanced print' drug warnings to improve patient comprehension beyond a current standard.A three-arm, controlled clinical trial was conducted. Patients were assigned to receive 1) current standard drug warning labels on prescription containers (standard), 2) 'enhanced' drug warnings with text rewritten in plain language (enhanced text), or 3) enhanced language and icons developed with patient feedback (enhanced text + icon). Setting: Two academic and two community health primary care clinics in Chicago, IL and Shreveport, LA. Patients: 500 adult patients consecutively recruited at each clinic. Main Outcome Measure: Rates of correct interpretation of nine drug warning labels as determined by a blinded panel review of patients' verbatim responses.
This proposed research is relevant to human health because preemptive clinical pharmacogenetic testing may improve the personalization of drug therapy which should improve patient outcomes. Better understanding of the effectiveness and feasibility of preemptive clinical pharmacogenetic testing will inform when and how this innovative healthcare technology is implemented into clinical care. To ensure equitable dissemination in all patient populations, such data is also needed in racial minorities and other traditionally underserved populations. The combined proposed research are relevant to the parts of the NIH's mission pertaining to protecting and improving health and developing scientific human resources that will ensure the Nation's capability to prevent and treat disease.
Half or nearly half of college students with prescriptions divert their stimulant medication, and a similarly high percentage misuse their medication or use someone else's prescription. Diversion may lead students to go without needed medication to mitigate their symptoms, increasing their risk for unintentional injuries and substance use. Further, diversion perpetuates the non-medical use of prescription stimulants (NMUPS), which has become increasingly common among college students. Diversion also perpetuates medical misuse of stimulants among students with prescriptions, which is associated with poorer attention-deficit/hyperactivity disorder (AD/HD) symptom management and may increase the risk for addictive disorders. There are no evidence-based interventions targeting diversion of stimulants in college students. Being approached for one's medication is a key risk factor for diversion, as is medication non-adherence and believing NMUPS and diversion are more prevalent than they are. Accordingly, in this multi-site study, the investigators will conduct a randomized, controlled trial of 300 college-attending adults with current stimulant prescriptions to examine the preliminary efficacy and feasibility of a single-session, computer-based simulation intervention (with two booster sessions) to prevent prescription stimulant diversion and medication misuse and compare it to a placebo condition. The intervention, which is grounded in social learning theory and the theory of planned behavior uniquely engages students in interactive discussions with virtual humans to (a) learn about the actual prevalence of NMUPS and diversion and their related risks, (b) practice using refusal strategies when approached for their medication in high-risk situations, and (c) understand how to effectively communicate with prescribers and avoid medication misuse. The primary aims are to determine if the intervention reduces diversion, intentions to divert, and medication misuse, and to assess user satisfaction with the intervention. The secondary aims are to examine change in potential mechanisms of action targeted in the intervention, such as self-efficacy to resist diversion, knowledge about diversion and NMUPS, use of behavioral strategies to resist requests for one's medication, and prescriber communication. If effective, the intervention could be readily and widely disseminated to college counseling centers, psychiatrists, pediatricians, and other prescribers.
This is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. In addition, it will test whether patient-centered education decreases the quantity of narcotics prescribed and/or increases patient satisfaction and preparedness.
Nonmedical prescription stimulant use (NPS) is commonly reported among college students for cognitive enhancement purposes, though it is associated with numerous negative psychological and physical consequences. Despite increasingly high prevalence rates and widespread acknowledgement of the need for efficacious interventions, little is known regarding how to prevent or treat this behavior. An intervention that targets cognitive enhancement motives and expectancy effects related to NPS may be particularly effective in light of recent research purporting limited evidence for meaningful NPS-related cognitive improvements among individuals without legitimate attention deficits. The primary objective of this proposal is to examine the efficacy of an intervention that successfully prevents NPS among college students by modifying expectations for NPS-related effects, while at the same time providing alternative means of enhancing cognition and arousal. Participants will be 126 stimulant-naïve college students who report a combination of risk factors for NPS. They will be randomized to one of three treatment conditions: a placebo-based expectancy challenge intervention that solely aims to modify expectancies related to NPS, a caffeine-based expectancy challenge intervention that includes expectancy modification combined with a safer alternative for cognitive enhancement, or a control group. Multilevel mixed modeling and survival analyses will be used to 1) examine changes in NPS-related expectancy effects across a 6-month follow-up period, and 2) assess incidence of NPS over the follow-up period, respectively, across the three groups. It is hypothesized that both expectancy challenge interventions will successfully modify expectancies compared to the control group and that they will be maintained over the follow-up period. It is also expected that the caffeine-based intervention will most successfully prevent NPS through a combination of expectancy modification and encouraging safe use of caffeine rather than prescription stimulants to achieve desired outcomes. Mediational analyses will also be employed to assess whether changes in expectancy effects via the interventions are responsible for differences in initiation rates between groups. The results of this project will facilitate the development of larger-scale prevention efforts to target the high rate of NPS on college campuses.