6 Clinical Trials for Various Conditions
Alcohol Use Disorders (AUDs) have a significant public health impact and are highly prevalent in Veterans. Alcohol related brain effects on neurocognition (attention, memory and executive function) reduce ability to benefit from current treatments. These cognitive impairments are especially common in the early phase of recovery, persist over years and get worse with age. Recent research suggests that cognitive remediation therapy (CRT) may improve attention, memory and executive function in other disorders, and the investigators just completed pilot study with AUD Veterans found significantly greater improvements for those receiving CRT. The proposed study examines AUD outcomes and neurocognitive improvements when CRT is combined with a standardized alcohol treatment. The investigators hypothesize that CRT will improve neurocognition and AUD outcomes more than standardized alcohol treatment alone. Findings will determine whether CRT augmentation can benefit Veterans with AUDs.
This is an open label feasibility trial to learn whether the combination of donepezil and cognitive remediation therapy (Donepezil + CRT) may improve neurocognitive functioning and decreasing alcohol use in Veterans with alcohol use disorder who have mild cognitive impairment (AUD-MCI). The study will determine the acceptability and adherence to treatment and preliminary evidence for efficacy. The study will recruit 15 newly recovering Veterans individuals with AUD-MCI for a 13-week, open-label, single-arm pilot study with sobriety and cognitive assessments at baseline and at 13-week follow-up.
The objective of this proposal is to advance medication development for alcohol use disorder by examining the efficacy and mechanisms of action of minocycline, a neuroimmune modulator, as a potential treatment. This study has important clinical implications, as the available treatments for alcohol use disorder are only modestly effective and testing novel medications is a high research priority.
The project will examine whether a computerized neuroscience-based cognitive training program can improve cognitive functioning and recovery outcomes among Veterans with Alcohol Use Disorder and co-occurring PTSD. Information from this study will help determine the malleability of cognitive dysfunction, an established risk factor for poor recovery outcomes in this population. Improved functional outcomes can decrease risk of chronic impairment and ultimately help affected individuals live richer, more productive lives. Web-based treatment technologies may increase the reach and impact of treatment, and foster patient recovery in cases where staffing, space, acceptability of counseling, and transportation are barriers. Findings may also support expanding use of existing, highly-accessible cognitive remediation technologies to other vulnerable clinical populations.
Alcohol misuse is a risk factor for early onset cognitive impairment, contributing to 10% of early onset dementia, with risk corresponding to consumption. Additionally, continued drinking risks worsening cognitive decline and dementia progression, while worsening cognitive impairment contributes to drinking escalation. Repetitive transcranial magnetic stimulation (rTMS) has been shown to improve cognition in Alzheimer's Disease and Related Dimentias (ADRD) and separately reduce heavy drinking in alcohol use disorder. Our objective is to optimize rTMS for simultaneous mitigation of both drinking and cognitive dysfunction in older adults.
The objective for this project is to determine whether how certain behavioral and health functions change in persons with heavy drinking when they stop (or reduce) drinking for 30 days, and whether changes continue for up to 90 days. The study will also identify barriers and facilitators related to drinking reduction. The project will focus on clinical comorbidities including HIV disease control, cognitive and brain function, liver abnormalities, and chronic inflammation. The study teams propose to enroll 140 HIV+ and 40 HIV- adults with heavy drinking, and then use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption for 30 days. Participants will be required to wear an ankle biosensor (SCRAM monitor) at all times, which is used to monitor participants' drinking behavior. At 30 days, participants will complete a full day of follow-up, including cognitive testing, neuroimaging, blood testing, liver Fibroscan, and questionnaires. Many participants will also provide a stool sample for gut microbiome assessment at each time point. At 30 days, participants will participate in a motivational interview to discuss perceived benefits and obstacles to drinking reduction, and most participants will continue CM to 90 days (but can opt out at this point). Participants will complete another full-day assessment at 90 days, at which point persons may choose to drink or not on their own (no more CM). A final assessment will be conducted at 12 months. This A-B-A design will enable us to clearly identify whether alcohol effects on cognition and brain function are reversible in the context of HIV, and analyze specific cerebral and systemic pathophysiological factors contributing to these effects. The inclusion of HIV- adults will enable subgroup comparisons of alcohol reduction effects in the context of HIV vs. no-HIV. These HIV-negative participants will be recruited from the same settings as our HIV+ participants, and will include a similar proportion by age, race, and gender as the HIV+ participants. The study team will use information from the MI data and our other assessments to elucidate factors that predict both short term (during CM) and long-term (1-year) alcohol reductions, and study how changes in alcohol consumption affect important HIV clinical outcomes that will be monitored over time.