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33 active trials for Alcohol Dependence

Epi-Genetic Modulators of Fear Extinction in Alcohol Dependence

Background: - Researchers want to learn if people with alcohol dependence have more difficulty learning to feel calm, or learn to fear things more easily. They also want to study how early life stress (ELS) affects the ability to learn to feel calm. Objective: - To see if people with alcohol dependence and/or ELS have a harder time learning to feel calm than people without these. Also, to see if DNA is changed by ELS and if this change affects fear conditioning and extinction. Eligibility: Adults ages 21-65 with and without an alcohol use disorder (AUD) and with and without ELS. Healthy volunteers. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Psychological tests Treatment for symptoms of alcohol withdrawal, if needed Healthy volunteers will have 1 overnight visit (2 days, 1 night). AUD participants will stay at the clinic for about 4 weeks. Participants will: Rate alcohol use/craving, depression, anxiety, and childhood trauma. Have psychophysiological measures: electrodes and mild electric shock. Have a functional magnetic resonance imaging (MRI) scan. Participants will lie on a table in a metal cylinder with a coil over their head. In the first scanning session, they will see pictures, do a simple task, and may get shocks. Participants will also do a second scanning session in which they will perform the aforementioned fear conditioning and extinction task, as well as a facial expression matching task, an affective word processing task, and a task measuring valuation of monetary rewards. Answer questions about their emotions (some participants). Have blood drawn from an arm vein or intravenous (IV) line. AUD participants will get a dexamethasone pill. The next day, they will get a hormone injected in and have blood drawn from an IV line. AUD participants will have 3 follow-up visits with questions and blood and lab tests.

Start: August 2015
Effect of Theta Burst Stimulation on Alcohol Cue Reactivity

Alcohol Use Disorder (AUD) is prevalent, devastating, and difficult to treat. The intransigence of AUD is readily apparent in the Trauma Unit of Wake Forest University Baptist Hospital, wherein 23% of trauma related admissions are associated with alcohol - higher than the national average of 16%. Of these trauma related admissions, over 70% are estimated to have AUD and 41% will be likely be admitted to the trauma unit again within 5 years. While Dr. Veach (Co-Investigator) and her team in the Department of Surgery have demonstrated that a brief counseling intervention on the inpatient trauma unit can decrease morbidity and recidivism, the rates of AUD and relapse to drinking among these individuals remains very high. With a growing knowledge of the neural circuits that contribute to relapse in AUD, there is an emerging interest in developing a novel, neural-circuit specific therapeutic tool to enhance AUD treatment outcomes. This will be achieved through a double-blind, sham-controlled cohort study in 48 heavy alcohol drinkers with a history of alcohol-related injury. The brain reactivity to alcohol cues (Incentive Salience) and cognitive performance in the presence of an alcoholic beverage cue (Cognitive Control) will be measured immediately before and after participants receive real or sham intermittent theta burst stimulation (iTBS- a potentiating form of transcranial magnetic stimulation (TMS)) to the dorsolateral prefrontal cortex (dlPFC iTBS). The goals of this pilot study are to quantify the acute effect of a single session of real or sham dlPFC iTBS on brain response to alcohol cues (Aim 1) and cognitive flexibility in the presence of an alcohol cue (Aim 2) among risky drinkers (target engagement ).

Start: August 2020
Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder

Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current Stimulation (tDCS) allows to stimulate superficial areas of brain using a weak electrical current. Preliminary data suggest that tDCS may reduce alcohol craving and consumption. Objectives: The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels. Secondary outcomes are the assessment of other psychiatric dimensions (mood, behavioral and cognitive alterations) associated with prolonged alcohol use. Eligibility: Healthy, right-handed adults ages 18-65 who do have AUD (moderate to severe). Design: This is a randomized, double-blind, sham-controlled study with three phases: 1) a tDCS intensive treatment phase; 2) follow-up with weekly tDCS stimulation; 3) follow-up without tDCS stimulation. Participants will be screened with: Psychometric Scales Medical history Physical exam Urine tests and breathalyzer After being enrolled, baseline behavioral and laboratory data will be collected. In particular, participants will undergo: Psychometric Scales Venous blood sample (BDNF/proBDNF levels) Participants will be randomized to real or sham tDCS arm. The stimulation will be delivered daily for five days during the first week (intensive treatment phase) and then weekly for 3 months (follow-up with stimulation). During this period patient will be tested with a behavioral and psychometric evaluation.Therefore, participants will receive 3 follow-up monthly visits without tDCS stimulation, in which behavioral and psychometric data will be collected. Treatment includes: tDCS: The tDCS will be delivered with a stimulator connected to two sponge electrodes, soaked in a saline solution. The stimulation will be administered at a current intensity of approximately 1 mA, for the duration of 20 minutes. The anode will be placed on the right DLPFC, the cathode on the contralateral cortical area. BDNF/proBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first week). The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis. Repeat of screening tests and questionnaires Urine toxicological screen and breathalyzer

Start: July 2021
RCT of Web-Based Behavioral Sleep Intervention for Individuals With Alcohol Use Disorder

Background: Many people with alcohol use disorders have a sleep problem called insomnia. One treatment is Cognitive Behavioral Therapy for Insomnia (CBT-I). Researchers want to study people s experiences with a web-based CBT-I program called SHUTi. Objective: To test if a web-based insomnia therapy program works well and helps people with alcohol use disorders. Eligibility: Adults ages 18-65 who joined another protocol and have been an inpatient on that protocol at least 14 days. Design: Participants will be screened with questions about insomnia. They will wear a device on their wrist and finger for one night while sleeping. This checks for sleep apnea. Participants will complete 1 of 2 programs: SHUTi: Participants will start using the program in the hospital and finish it about 6 weeks later. They will get a computer tablet to access SHUTi at least 3 times a week. They will get surveys, stories, videos, and interactive data about sleep. They will complete at least 5 daily sleep diaries every week. SHUTi will be customized based on the diaries. Education-only program: This is like SHUTi but it is not interactive and is not customized. Participants will access it at least once a week. They will finish at their own pace within 6 weeks. These participants may access SHUTi later. All participants will wear a device on their wrist for 4 straight days at several different time points. It records activity and sleep data. They will do this 3 times. Participants will answer questions about the program before starting it and after finishing. Interviews will be audio recorded. Participants will do follow-up surveys 6-7 months after they are discharged from the hospital.

Start: March 2019
Patient Trajectories for Older Adults Admitted to Hospital for Alcohol-related Problems

Alcohol is contributing to many health problems and disorders, as well as accidents and social problems. Alcohol consumption has been on the rise the past 25 years, especially in Norway. The highest increase is found in older adults, in line with the development in most other countries in the western world. Older adults have a higher risk for alcohol related health problems, due to age related physiological changes, medical conditions and medications. Still, alcohol use is seldom addressed for older people. This means that older people rarely receive help to change alcohol habits. Norwegian health authorities have issued mandates ordering the regional health trusts to implement strategies in somatic hospital wards, mental health services and drug treatment services to identify and treat alcohol and drug problems affecting the patients' health. In this observational study we will explore patient trajectories three years prior to and three years after an admittance to hospital where risky or harmful alcohol consumption is identified and brief interventions are delivered. Hospitals that have implemented such strategies are invited to the study. Patient trajectories are studied in national health registries. This will provide important knowledge on what characterizes the patients identified, and what happens after they have received a brief intervention related to a hospital admittance.

Start: October 2019
Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Alcohol Dependence

Alcohol dependence is one of most common substance dependence, which brings great burden on health worldwide. Alcohol dependence may lead to many serious diseases or consequences including cancer, cardiovascular diseases and accidents. Once alcohol dependence is developed, it will be difficult to recover and easy to relapse. Although many efforts had been made in the treatment of alcohol dependence, the annual recurrence of alcohol dependence with traditional therapies was over 45%. Repetitive transcranial magnetic stimulation (rTMS) on the dorsolateral prefrontal cortex (DLPFC) or cognitive behavioral therapy (CBT) each alone was reported to have some effect on preventing from relapse of alcohol dependence. In order to test whether combined therapy of high frequency rTMS (hf-rTMS) with CBT is better for preventing from relapse of alcohol dependence, we recruit patients with alcohol dependence to participate this study. The study is a factorial designed and the patients will be assigned into one of the following six groups randomly: (1) regular treatment (symptomatic treatment) with blank TMS; (2) regular treatment (RT) with blank TMS and CBT; (3) RT with right DLPFC hf-rTMS; (4) RT with right DLPFC hf-rTMS and CBT; (5) RT with left DLPFC hf-rTMS; (6) RT with left DLPFC hf-rTMS and CBT. TMS was given 5 days per week for total 2 weeks using uniform scheme (5 seconds of 10Hz stimulation per train, 30 trains per day with inter-train interval of 20 seconds). CBT will be given once per week for total 8 weeks. The patients will be followed up for 6 months. Recurrence of alcohol dependence, duration of abstention, alcohol intake, craving for alcohol and other cognitive psychological assessments will be recorded and compared among the 6 treatment groups and the efficacy of combined therapy of rTMS with CBT will be evaluated in our study.

Start: June 2019