Auburn

Researchers are evaluating a combined neurofeedback and transcranial magnetic stimulation (TMS) intervention for individuals receiving treatment for Alcohol Use Disorder. The study aims to test the effectiveness of supplemental functional MRI (fMRI) neurofeedback and/or TMS in reducing alcohol craving and improving related behaviors over time. Participants are adults aged 19 to 65 who are currently undergoing treatment for this condition. Participants will attend an initial visit followed by weekly intervention sessions for four weeks. These sessions may include active or sham fMRI neurofeedback to help regulate craving and active or placebo TMS applied to the right dorsolateral prefrontal cortex to reduce craving. The intervention uses brain imaging and stimulation devices to provide feedback and brain modulation. After the intervention period, participants will have monthly remote follow-ups for up to 12 months and will return for two MRI follow-ups at 6 and 12 months. Throughout the study, researchers will assess changes in alcohol use, craving, community functioning, employment status, aggression, antisocial behavior, and brain activity related to alcohol cues and sociomoral stimuli. These outcomes are measured repeatedly at baseline, during intervention sessions, and at multiple follow-up points over the year. Safety and adherence will be monitored, and the total participation duration includes the initial intervention and a year of follow-up assessments.

This research focuses on participants with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. It is a long-term extension study following a previous trial, aiming to evaluate the long-term safety, tolerability, and effectiveness of the drug ORX750 in these conditions. The study is part of a Phase 2 clinical trial program specifically involving participants who completed the initial parent study. Participants will receive oral ORX750 during the long-term extension period. This open-label study continues treatment with ORX750, allowing researchers to observe its effects over an extended time without a placebo comparison. The study builds upon prior treatment to assess ongoing outcomes and safety. During the study, participants will be closely monitored for any treatment-emergent adverse events, serious adverse events, abnormal lab tests, changes in vital signs, abnormal ECG results, and any signs of suicidal thoughts or behavior up to day 70. The study requires participants to adhere to protocol requirements and will assess their continued safety and response to ORX750 throughout the treatment period.

Researchers are exploring new ways to improve how children and adolescents with intellectual and developmental disabilities (IDD) learn self-control and communication skills to reduce severe problem behaviors, such as tantrums or crying. The study focuses on making behavior-change treatments more effective and long-lasting, even when environments or reinforcement schedules change. It also examines how cognitive and behavioral factors like memory, timing, and decision-making influence treatment success. Participants will undergo assessments to identify preferred activities and understand the causes of their challenging behaviors. They will be taught functional communication skills to replace problem behaviors with appropriate actions, such as requesting attention. The study includes using extinction-correlated stimuli during treatment, caregiver training to implement interventions, schedule thinning to reduce reinforcement density, and multiple-context training to help skills generalize across different settings and people. During the study, participants will complete evaluations including preference assessments, functional behavioral assessments, and generalization tests. Caregivers will be trained and monitored for treatment fidelity. Researchers will track changes in challenging behaviors from enrollment through the 16-week intervention, focusing on the renewal and resurgence of problem behaviors. The goal is to see how well participants maintain new skills and reduce problem behaviors over time and across different situations.

Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are rare sleep disorders causing excessive daytime sleepiness, making it difficult for people to stay alert during daily activities like school, work, or driving. NT1 often includes sudden muscle weakness called cataplexy triggered by strong emotions, while NT2 does not have cataplexy. People with IH feel tired even after long sleep and may have trouble waking up. This study aims to evaluate the safety, tolerability, and effects of ORX750, a drug designed to mimic orexin, a brain protein that helps keep people awake, in individuals with NT1, NT2, and IH. Participants will be randomly assigned to receive either ORX750 capsules or matching placebo capsules in this Phase 2a trial. The study will compare the drug against placebo to learn about its safety, how the body processes it, and its potential to reduce sleepiness and improve symptoms in these conditions. Participants must stop all other narcolepsy or hypersomnia medications and follow study requirements throughout the trial. During the study, researchers will monitor participants for treatment-related side effects, changes in laboratory tests, vital signs, heart electrical activity (ECG), and any suicidal thoughts or behaviors up to day 35. The main outcomes focus on safety and tolerability of ORX750. The study includes adults aged 18 to 65 years with specific diagnoses of NT1, NT2, or IH and tracks their response and health closely during the trial period.

This research aims to understand how brain activity affects recognition of cannabis use-related problems in people with severe cannabis use disorder. It investigates whether changing activity in a specific brain area, the medial orbitofrontal cortex, influences awareness of problems related to cannabis use. The study compares three types of brain stimulation, including sham (placebo), intermittent, and continuous theta burst stimulation, to see how these affect problem recognition. Participants will undergo three different brain stimulation sessions using transcranial magnetic stimulation (TMS) targeting the medial orbitofrontal cortex. The three types of stimulation are sham TMS, which mimics the procedure without active effects; active intermittent theta burst stimulation (iTBS); and active continuous theta burst stimulation (cTBS). Each active session delivers bursts of magnetic pulses at specific frequencies and intensities. The study includes four in-person laboratory visits with questionnaires, four brief MRI scans, three TMS sessions, and three EEG sessions. Urine, saliva, and breathalyzer samples will also be collected during some visits. During the study, participants will complete mental health and substance use interviews and provide biological samples to confirm cannabis use. Researchers will measure brain blood flow and electrical responses to cannabis-related information at multiple visits. Outcome measures include cerebral blood flow in the target brain region and neurophysiological responses to cannabis-related stimuli. The study involves close monitoring of safety and adherence to procedures, with a total participation period covering screening and four lab visits over several weeks.

Researchers are investigating whether supplements of curcumin and epigallocatechin gallate (EGCG) can improve mood symptoms and increase serum brain derived neurotrophic factor (BDNF) levels in adults aged 18 to 50 with mood disturbances characterized by elevated DASS-21 subscale scores. This early phase 1 randomized placebo controlled trial aims to clarify the effects of these supplements on mood disturbance and BDNF over an 8-week period. Participants are randomly assigned to either an intervention group or a placebo group. Those in the intervention group take 1,330 mg of curcumin and 350 mg of EGCG daily for 8 weeks. The placebo group receives a matching placebo during the same timeframe. This supplementation period is the main study phase. Throughout the study, participants undergo blood draws at the start and end of the 8 weeks to measure serum BDNF. Mood symptoms are evaluated using questionnaires at baseline, 4 weeks, and 8 weeks. Three days of diet recalls are collected at these same time points. Daily reminders help participants maintain their supplement routine. The primary outcomes measured at 8 weeks include changes in mood disturbance using the DASS-21 total score and changes in serum BDNF levels.

Researchers are evaluating the effects of a four-week digital intervention on physical activity and depressive symptoms in adults experiencing moderate or higher levels of depression. The study aims to find out if this digitally delivered program can increase physical activity and reduce depression symptoms by comparing it to a passive control group that does not receive the intervention. Participants include adults aged 19 to 40 years who have moderate depressive symptoms and are physically inactive. Participants will be randomly assigned to either a digital physical activity intervention or a passive control group. Those in the intervention group will download the Pathverse mobile app on their Apple or Android smartphones, which will send daily notifications encouraging engagement in physical activities they select and enjoy. They will report the type, duration, and intensity of physical activities performed during the four-week period. The control group will have their mental health monitored over the same time without receiving the intervention and will be offered the digital program afterward if desired. Throughout the study, participants will attend four lab visits—two before and two after the intervention—with one week of physical activity monitoring before and after group assignment. Researchers will measure depressive symptoms and levels of moderate-to-vigorous physical activity at these time points. Participants must keep their mobile device on during the study and report their physical activity daily. The total participation period includes these visits and the four weeks of intervention or monitoring.

Researchers are evaluating if a modified form of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who experience new low back or leg pain due to acute lumbosacral musculoskeletal conditions, including spinal stenosis and sciatica. This is a double-blind, randomized, placebo-controlled Phase 4 study comparing the active drug to a look-alike placebo. The purpose is to measure changes in pain and how it affects physical activity and sleep over one week. Participants will be randomly assigned to receive either metaxalone 640 mg oral tablets along with standard care or a placebo that looks the same but contains no active drug. The study consists of an initial pilot phase followed by a larger phase with more participants to confirm results. Treatments are taken as oral tablets, and participants continue their usual care. During the study, participants will complete surveys on Day 1 before starting treatment and again on Day 7 to report pain levels, pain quality, and how pain affects their physical activity and sleep. Researchers will monitor changes in pain using a Numeric Pain Scale from Day 1 to Day 7. Participants must be able to respond to text or email reminders for surveys. The total study duration for each participant is 7 days of treatment and follow-up.

Researchers are conducting a two-phase pilot study to explore the feasibility and acceptability of a 12-week Chair Yoga program for heart failure patients aged 55 and older living in rural areas of the Deep South. The study aims to engage patients and stakeholders in developing and refining the yoga intervention to improve cognitive function and patient-centered outcomes. This research focuses on heart failure and rural health challenges by involving community input to tailor the approach. The study involves delivering a Chair Yoga intervention online over 12 weeks to two groups of 10 patients each. During Phase 1, the initial protocol is developed with stakeholder input, and the first 10 patients complete the yoga program while data are collected before and after the intervention. Phase 2 includes piloting a revised protocol with the next 10 patients, again delivering 12 weeks of online yoga and collecting pre- and post-intervention data. Stakeholders help finalize the protocol and disseminate findings after evaluating the feasibility results. Participants will undergo assessments including the Essential Properties of Yoga Questionnaire after the 12-week intervention to capture their perceptions and experiences with yoga. Cognitive function is measured at baseline using the Montreal Cognitive Assessment. The study tracks feasibility, acceptability, and cognitive outcomes while incorporating patient feedback to refine the program. The total participation includes the 12-week yoga intervention and associated evaluations.

Researchers are studying whether osteopathic manipulative treatment (OMT) can help improve both physical and psychological aspects of chronic low back pain in adults. The focus is on the connected muscle and fascial system of the back, legs, and feet. This pilot study involves twenty adults with chronic low back pain lasting more than three months or occurring more than half the time over the past year. The goal is to gather early evidence on how OMT may affect muscle function, movement, pain, and overall well-being to guide future larger studies. Participants will receive four sessions of OMT over 5 to 7 weeks. OMT is a hands-on therapy where trained physicians use gentle pressure, stretching, and guided movements to improve mobility, reduce pain, and support natural healing by addressing the connections between muscles, joints, and fascia. The treatment focuses specifically on the muscles and soft tissues of the leg and foot as they relate to low back pain. During the study, researchers will measure muscle stiffness using ultrasound shear wave elastography and assess body sway through pressure plates while walking. Participants will also complete surveys about pain, disability, sleep quality, stress, anxiety, depression, pain catastrophizing, and pain self-efficacy. These measurements will be taken from the start of the study through the last OMT session, up to 6 weeks. This combination of objective and subjective data aims to show how OMT may influence musculoskeletal function, daily activities, and overall health.