View clinical trials related to Alcohol Dependence.
Filter by:Building on the large body of evidence for the effect of exercise in decreasing depressive symptoms and the few preliminary findings of its effect on craving and drinking outcomes, the purpose of this study is to develop a lifestyle physical activity (LPA) intervention that harnesses the technological advantages of the Fitbit tracker (plus its web and mobile platforms) for depressed women with alcohol use disorders (AUDs). The intervention will provide women with an acceptable, flexible and effective alternate coping strategy during early recovery, when relapse risk is highest. The overall objective of this work is to fully develop this LPA+Fitbit intervention, modify it based on initial piloting and feedback to ensure its feasibility and acceptability for depressed women with AUDs in early recovery, propose potential mechanisms of its effect, and to obtain preliminary data on its efficacy.
Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and alcohol use over weeks 1-24. Hypothesis 1: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP). Hypothesis 2: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce better alcohol use outcomes than an intervention focused on engagement in IOP only (MI-IOP). Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and alcohol use outcomes in each option. Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and alcohol use outcomes in each option. Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC varies as a function of engagement group, with regard to treatment engagement over weeks 1-12 and alcohol use outcomes over weeks 1-24. Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group. Hypothesis 2: The predicted main effect on cocaine use outcomes favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.
The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.
The purpose of this research is to examine the effects of exercise of different intensities on psychological, physiological, biochemical, physiological and alcohol-related parameters in individuals with alcohol use disorders (heavy drinkers and alcoholic patients) in order to investigate possible biochemical mechanisms by which exercise may be a healthy alternative to alcohol abuse. For that purpose, a control group of individuals that do not exceed the limits for moderate alcohol use will be included.
The Soberlink Cellular device, in its original packaging, along with the QuickStart guide will be provided to the end user in a simulated home use environment or by Rx in clinic. The patient labeling will be in the format intended for distribution. Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device while an additional ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten (10) simulated home use subjects will be provided instruction for use for the Soberlink Cellular device while an additional ten (10) simulated home use subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. All subjects will be provided with a post-test questionnaire on how to operate the device. The post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.
It is well-established that many substance misusers experience impairment in cognition (thinking skills), particularly those needed to regulate and monitor behaviour and ensure that goals are achieved. According to the dual-process model, addiction arises from an imbalance in 'bottom-up' processing i.e., overactive automatic (impulsive) processes that drive behaviours and impaired 'top-down' controlling processes that stop behaviours associated with negative consequences. As a result, the individual becomes more sensitive to cues in their environment (e.g., alcohol images) that trigger the addictive behaviour. Cognitive-bias modification (CBM) is a novel, computer-based training paradigm that trains the brain to pay less attention to negative/harmful cues and more attention to positive or neutral cues. This approach minimizes the overactive 'bottom-up' processes and improves the 'top-down' control processes of unhealthy behaviors which enables the addicted individual to make better decisions. Recently, CBM has been used with addicted population to alter the tendency to approach alcohol, with one German study showing that a 4-session training programme was associated higher rates of abstinence at one-year (Wiers et al., 2011). The current study examines whether a novel computer based training programme alters cognitive biases (the tendency to approach alcohol related stimuli) in alcohol-dependent inpatients, and examine whether this enables them to be better at decision-making more generally, and its impact on craving and post-discharge abstinence rates. The study will also explore whether individual differences in impulsivity and sensitivity to reward and punishment determine response to the training programme. This will be achieved using a parallel-groups randomized superiority trial design involving approximately 80 patients attending inpatient withdrawal programmes in Victoria. The findings are likely to have implications for the design and delivery of psychosocial interventions delivered during early recovery from alcohol-dependence to optimise treatment effectiveness.
Extending previous findings, and applying a novel multi-method translational approach, this project hypothesizes that there are alcohol-related neuroendocrine and neural changes observable in acute and protracted abstinence, and which can accurately classify future relapse and treatment outcome in separate alcohol dependent (AD) patient samples, thereby validating them as biomarkers of relapse, with potential clinical utility as prognostic markers in identifying and treating those most susceptible to relapse.
The proposed study, for HIV positive alcohol dependent adults currently taking naltrexone, is a pilot randomized controlled trial (RCT) examining the outcomes of a 12-week behavioral support program delivered via text-messaging. It is expected that the text messaging intervention will reduce alcohol use and HIV-risk behaviors. The investigators also hypothesize that the intervention will improve adherence to HIV treatment and naltrexone. To test the effects of the intervention on these target outcomes, 25 participants receiving the text messaging intervention will be compared to 25 participants receiving an informational pamphlet. The pamphlet will contain information about the importance of HIV treatment adherence, reducing HIV risk behaviors, and health consequences associated with alcohol use. By providing support to maximize HIV treatment regimen and naltrexone adherence, coupled with coping skills to promote abstinence from alcohol, the text messaging intervention may provide a promising, cost-effective, and easily deployable behavioral support program for alcohol users who are HIV-infected.
Background: The way alcohol affects brain structure has been widely studied. But the way it affects all parts of the brain is still unknown. Researchers want to use magnetic resonance imaging (MRI) scans to study brain structure and function. They hope this will help them better understand changes that happen in brain regions during treatment of alcohol use disorders. Objectives: To study changes in the brain by using MRI in people with and without alcohol use disorders. To study how brain changes affect gait, balance, cognitive ability, and behavior. To see how the brain recovers when alcohol use stops. Eligibility: People with alcohol dependence who are currently hospitalized in a particular unit at NIH. Healthy volunteers 30 60 years old without an alcohol use disorder. Design: Participants will be screened under a separate protocol. Participants will give a urine sample for a drug test and pregnancy test at each study visit. They will also have to pass a breath alcohol test. At the first visit, participants will have an MRI. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. They will do behavior and memory tasks outside the scanner. They will have gait and balance tested. They will have to stand on both legs, stand on just one leg, and walk in a straight line. They will perform each task with eyes open, then with eyes closed. They will have tests of memory, thinking, and problem solving. Some participants will have a second visit. They will have another MRI and repeat some of the behavior and memory tasks. ...
This current project investigates the effect of a single session of right dlPFC repetitive transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol dependent patients and healthy controls.