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Alcoholism clinical trials

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NCT ID: NCT02711189 Withdrawn - Alcoholism Clinical Trials

Oxytocin in Alcohol Use Disorder

Start date: March 8, 2016
Phase: Phase 1
Study type: Interventional

Background: Oxytocin is a naturally occurring substance in the body. Studies show that oxytocin may affect how the body responds to alcohol. Researchers believe oxytocin may be a possible treatment for alcoholism. Objective: To test whether the hormone oxytocin affects the brain reward system. To see if it affects how people respond to alcohol and other rewarding things in life like food and seeing loved ones. Eligibility: Men ages 21-55 who have an alcohol use disorder. Design: Participants will have two 6-day inpatient study visits. They will have: - Study medication or placebo given twice daily as a nasal spray. - Height and weight measured. - Medical history. - Blood and urine tests. - Breath tested for alcohol. - Electrocardiogram. - An alcohol administration session. In a bar-like room, where participants will consume four alcoholic drinks. - Magnetic resonance imaging (MRI). The MRI scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. A device called a coil will be placed over their head. Participants will complete tasks on a computer screen. - In another alcohol session. they will drink an alcoholic beverage then answer questions. Participants will get a tab for eight more drinks ($3.00 per drink). They may drink any of the drinks or take the money. Participants will hold and smell a glass of water and their favorite alcoholic drink. - Heart rate and blood pressure will be monitored. - Saliva samples will be collected - Computer tasks and questionnaires. About one week after the end of visit 2, participants will return to clinic for a follow-up visit. Symptoms and side effects will be evaluated.

NCT ID: NCT02181608 Withdrawn - Stress Clinical Trials

Traits Associated With Early Life Stress Among Treatment-Seeking Alcoholics

Start date: June 19, 2014
Phase: N/A
Study type: Observational

Background: - Researchers want to see if people with alcohol dependence have more trouble learning to feel calm, or learn to fear things more easily, than non-alcoholics and to study how early life stress (ELS) affects these things. Objective: - To see if people with alcohol dependence and/or ELS have a harder time learning to feel calm than people without these conditions. Eligibility: - Adults age 21 65 with diagnosed alcohol dependence, with/without ELS. - Healthy volunteers age 21 65 with/without ELS. Design: - All participants will be screened with medical history and physical exam. They will have blood and urine tests, and a psychological assessment. - Participants with alcohol dependence will: - be at the NIH Clinical Center for 4 weeks. Then they will have weekly telephone calls and 3 in-person visits over 3 months. - follow the NIH alcohol treatment program during the study. They cannot take psychiatric medications. - rate their alcohol craving, depression, and anxiety throughout the study. - have fear conditioning and extinction sessions that use noise and mild electric shock. Some take place during a functional MRI (fMRI) scan. Participants will lie in a machine that takes images, while they perform tasks. - listen to recordings that describe stressful events. They will rate their feelings and have blood drawn through an intravenous (IV) line. - have their hormone response to stress tested. They will take a pill and get a hormone via an IV, then have blood drawn. - Healthy volunteers will: - have 2 inpatient stays, each lasting a few days. They will answer questions about how they feel. - have fear conditioning and extinction sessions, including fMRI. - have blood drawn several times.

NCT ID: NCT01853293 Withdrawn - Alcohol Dependence Clinical Trials

Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons

Start date: March 2014
Phase: Phase 2
Study type: Interventional

This research is designed to assess if problem drinking by treatment seeking individuals can be treated (reduced) by kudzu extract pharmacotherapy plus medical management therapy.

NCT ID: NCT01847300 Withdrawn - Substance Abuse Clinical Trials

cSBI-M for Young Military Personnel

Start date: September 2013
Phase: N/A
Study type: Interventional

The goal of this project is to test the efficacy of a computer-facilitated Screening and Brief Intervention system adapted for Military use (cSBI-M) in reducing substance use among 18- to 25-yr-old U.S. Navy and U.S. Marine Corps personnel (USN/USMCs). The aims and hypotheses of this project are to: 1)Test the effects of cSBI-M on any alcohol use. Hypothesis: Among 18- to 25-yr-old USN/USMCs coming for routine health screenings, those receiving cSBI-M will have lower rates of any alcohol use at follow-ups compared to TAU. 2) Test the effects of cSBI-M separately as a preventive, early therapeutic, and risk-reduction intervention. Hypotheses: (a) Among 18- to 25-yr-old non-drinking USN/USMCs (negative history of past-12-months drinking at baseline), those receiving cSBI-M will have lower rates of drinking initiation and heavy episodic drinking (HED, a.k.a. "binge" drinking). (b) Among 18- to 25-yr-old drinking USN/USMCs, those receiving cSBI-M will have higher rates of drinking cessation, reduced intensity of drinking (e.g., past-3-months drinking days, HED, and driving after drinking or riding with a drinking driver.(3) Test the effects of cSBI-M on tobacco use; explore its effects on other drug use. (4) Assess potential moderators (e.g., age, gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use), mediators (e.g., Patient to Provider Connectedness,17 perceived harmfulness of alcohol and drug use), and explore cSBI-M's mechanism of action. Hypotheses: among 12- to 18-yr-old patients coming for routine care, those receiving c-ASBI will have 1) lower rates of any alcohol use, of drinking initiation and riding with a driver who has been drinking, and 2) higher rates of drinking cessation, reduced intensity of drinking, heavy episodic drinking and driving after drinking or riding with a driver who has been drinking.

NCT ID: NCT01841892 Withdrawn - Alcohol Abuse Clinical Trials

The Therapeutic Workplace Intervention in Community Settings

Start date: April 2013
Phase: N/A
Study type: Interventional

Methadone is effective for heroin addiction, but many methadone patients continue to use cocaine. High magnitude and long-duration voucher-based abstinence reinforcement, in which participants receive vouchers exchangeable for goods and services contingent on providing drug-free biological samples, is one of the most effective treatments for drug addiction and can maintain cocaine abstinence over extended periods of time. Our research on a model Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which participants must provide drug-free urine samples to access the workplace and maintain maximum pay, can maintain cocaine abstinence and reduce drug-related HIV risk behaviors over extended time periods. Our next challenge is to disseminate employment-based reinforcement for the treatment of drug addiction. The investigators propose to develop, manualize, and pilot test a community-friendly Therapeutic Workplace intervention that can be implemented widely throughout the US and elsewhere. Methadone patients who use injection or crack cocaine during methadone treatment will be invited to participate (N = 58) and randomly assigned to one of two groups: Usual Care (control) group or Community Therapeutic Workplace group. As in our prior implementations of the Therapeutic Workplace intervention, Community Therapeutic Workplace participants will enroll in Phase 1 to initiate drug abstinence and acquire job skills. Participants who initiate abstinence and acquire job skills in Phase 1 will be hired into community workplaces with collaborating employers in Phase 2. During Phase 2, employment-based abstinence reinforcement contingencies will be implemented using procedures for workplace drug and alcohol testing overseen by the US Department of Transportation. Using this system, a national provider of Drug-Free Workplace Services will arrange random drug testing and employment-based abstinence reinforcement contingencies in which employees will be required to remain drug-free to maintain employment. The investigators hypothesize that participants in the Community Therapeutic Workplace group will provide more drug-free samples, and engage in fewer HIV-risk behaviors than participants in the Usual Care group. The study will provide vital information on the acceptability of the intervention to participants and employers, and provide preliminary data on the effectiveness of the investigators procedures to maintain abstinence and promote employment.

NCT ID: NCT01798888 Withdrawn - Alcoholism Clinical Trials

Deep Brain Stimulation for Refractory Alcoholism

Start date: November 30, 2012
Phase: Phase 1
Study type: Interventional

Background: - Current treatments for alcoholism have limited success. More than half of people with alcoholism return to uncontrolled drinking even after treatment or self-help programs. One possible treatment is the use of deep brain stimulation (DBS). DBS studies of the ventral capsule/ventral striatum, a region of the brain, reduced cravings for alcohol in a small group of alcoholics. DBS is approved for treating other disorders, such as Parkinson s disease, but not for treating alcoholism. Researchers want to study whether DBS can be used to treat chronic alcoholism. Objectives: - To see if deep brain stimulation is helpful and safe for people who have chronic alcoholism. Eligibility: - Individuals between 21 and 60 years of age who have been diagnosed with chronic alcoholism. - Participants must have tried for more than 10 years to stop drinking alcohol, and have failed multiple treatment and self-help programs. They may not have any other current substance abuse or dependence problem (except alcohol and nicotine). Design: - Participants will start the study by entering a separate alcohol detoxification study at the National Institutes of Health. They will be monitored during this study with blood tests and brain scans. - Participants will have 2 weeks of baseline tests. They will include physical exams and blood and urine tests. They will also include tests of thinking and memory, and questions about current moods. - Participants will have surgery to insert the DBS device. Electrodes will be placed in the brain and a battery pack will be placed in the chest. Participants will recover from the surgery and continue the alcohol detoxification program. - About 4 weeks after surgery, participants will be separated into two groups. For one group, the DBS device will be turned on with electrical stimulation and participants will be monitored for an additional two weeks in the hospital to find the right setting for the device. For the second group, participants will receive mock stimulation, but no real electrical DBS, and will also be monitored for an additional two weeks in the hospital. - Participants will return home for 24 weeks. During this time they will have frequent study visits to look at the DBS device. These visits will include questions about mood and memory, as well as imaging studies. - All participants will return for an additional two week inpatient stay in the hospital. Those participant who had initially received mock stimulation will now have their devices turned on with real electrical stimulation and will be monitored for the two weeks to find the right setting for the device. Those participants who had initially received real stimulation will continue to receive stimulation while being monitored for the two weeks. - Participants will return home for another 24. All participants at this point will have actual electrical DBS. Participants will continue to have frequent study visits for up to a year to look at the DBS device. These visits will also include questions about mood levels and alcohol cravings.

NCT ID: NCT01796158 Withdrawn - Alcohol Abuse Clinical Trials

Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use

Start date: September 2013
Phase: N/A
Study type: Interventional

The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients.

NCT ID: NCT01784653 Withdrawn - Nicotine Dependence Clinical Trials

Trial of Computerized MET for Adolescent Substance Use

Start date: October 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the effects of a computerized, self-directed Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and substance use. The investigators hypothesize that both iMET and MET will be more effective than TAU in engaging/retaining patients in treatment and in reducing substance use during a 12-month follow-up period. The investigators also hypothesize that Self-directed iMET will be as effective as the clinician-guided MET in increasing treatment engagement and abstinence during the 12-months follow-up period.

NCT ID: NCT01784627 Withdrawn - Nicotine Dependence Clinical Trials

Trial of Computerized SBI to Reduce Teen Alcohol Use

Start date: January 2015
Phase: Phase 1
Study type: Interventional

The goal of this project is to test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).

NCT ID: NCT01719458 Withdrawn - Obesity Clinical Trials

Norepinephrine Transporter Imaging in Addiction Disorders

Start date: July 2007
Phase:
Study type: Observational

In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24 obese individuals and 24 individually matched healthy control subjects and determine Norepinephrine Transporter (NET) expression in vivo using (S,S)-[11C]MRB and PET.