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Alcoholism clinical trials

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NCT ID: NCT02333357 Completed - Alcohol Abuse Clinical Trials

Multimedia Toolkits to Implement 12-Step Recovery Concepts in Group Counseling

Start date: March 2011
Phase: N/A
Study type: Interventional

This study is developing and testing a 12-step toolkit with five modules, training counselors to use them, and studying their frequency of use, desirability, effectiveness and patient outcomes. The toolkit includes counselor written guides, posters, client worksheets, engagement activities, and videos designed to be shown during substance abuse treatment group sessions to explain and encourage 12-step participation.

NCT ID: NCT02327858 Completed - Depression Clinical Trials

Supportive Text Messages to Reduce Mood Symptoms and Problem Drinking- Randomised Controlled Pilot Trials

Start date: July 2015
Phase: N/A
Study type: Interventional

According to the World Health Organisation, depression and problem drinking are among the leading causes of disability worldwide. Most patients who present with problem drinking and/or depression have poor quality of life and pose a great economic burden to society due to their higher use of health services. We seek to develop a new, enhanced, efficient, innovative and cost effective treatment strategy aimed at reducing the burden that these two mental conditions impose on sufferers, their families as well as the community and health systems. In a recent pilot study of supportive text messages in Ireland conducted by the Principal Applicant and a team of researchers for patients with problem drinking and co-occurring depression, we established that patients who received twice daily supportive text messages for three months had significantly less depressive symptoms than those who did not receive such messages. There was also a trend that patients who received the supportive text messages were more likely to have higher alcohol free days than those who did not receive any supportive text messages.Our study was limited by the small number of participants and it did not examine the impact of the text messages on health services utilization. Our study did not also examine the effects of supportive text messages on those with only depression or only problem drinking. The proposed study seeks to extend the knowledge gained from the pilot study in Ireland by examining the impact of supportive text messages in the individual disorders

NCT ID: NCT02322047 Completed - Clinical trials for Alcohol Use Disorder

Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders

PaN
Start date: March 3, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether the combination of prazosin and naltrexone will decrease alcohol cravings and drinking in individuals who have problems with alcohol and have used alcohol at risky levels compare to naltrexone and placebo (Nal/Pl), prazosin and placebo (Praz/Pl), and double-placebo (Pl/Pl). We hypothesize that those assigned to both prazosin and naltrexone would report significantly greater decreases in percent drinking days and heavy drinking days as well as significantly greater reduction in craving from pre to post-treatment than those assigned to either single medication or double-placebo. Prazosin is a medication that is approved by the U.S. Food and Drug Administration (FDA) to treat people with high blood pressure. Some studies have shown that prazosin may also decrease nightmares and improve sleep in Veterans suffering from Posttraumatic Stress Disorder (PTSD). Animal studies have consistently found that prazosin is associated with decreased alcohol consumption and that the combination of prazosin and naltrexone outperforms either medication alone. The current study is evaluating an "off-label" use of prazosin to determine whether it is helpful in decreasing alcohol cravings and consumption among people with alcohol problems. "Off-label" means that the FDA has not approved the use of prazosin for alcohol problems. Naltrexone is a medication that is FDA approved for treating alcohol problems. This study is sponsored by the Department of Defense and the Congressionally Directed Medical Research Program (DoD/CDMRP). We expect approximately 120 participants in this study, which will run over approximately 4 years. Study participants will be involved in the study for 7 weeks, or until they complete the Final Assessment.

NCT ID: NCT02316574 Completed - Alcoholism Clinical Trials

The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving

FRAME
Start date: December 2014
Phase: N/A
Study type: Interventional

Cognitive Behavioral Coping Skills Therapy (CBCST) is a commonly utilized, evidence-based psychosocial therapy (talk therapy) for alcohol dependence. By identifying the neural mechanisms through which CBCST changes drinking behavior, it may be possible to improve its efficacy. CBCST promotes abstinence by teaching "coping skills" for managing alcohol-related thoughts and emotions. In this pilot study, the investigators examine the neural systems that play a role in the learning of coping skills through CBCST, specifically focusing on the role of emotion regulation systems.

NCT ID: NCT02315885 Completed - Alcohol Dependence Clinical Trials

Biomarkers to Measure Treatment Response for Alcohol Dependence

Start date: July 2015
Phase: N/A
Study type: Interventional

The purpose of the research study of the K23 award is to develop a blood test that can check how much alcohol a person has consumed in the past few days. We will enroll heavy social drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a single occasion. Both men and women between ages 21 and 65 years can join the study. All participants must be of European decent.

NCT ID: NCT02298751 Completed - Clinical trials for Alcohol Use Disorders

Exposure Therapy as Aftercare for Alcohol Use Disorder

Start date: May 2015
Phase: N/A
Study type: Interventional

Background: It is well documented that individuals with Alcohol Use Disorder (AUD) respond well during evidence-based psychological treatment, but also that a large proportion relapse when discharged from treatment and confronted with alcohol in real life. Cue Exposure Therapy (CET) focuses on confronting alcohol cues in order to reduce cravings as well as the likelihood of relapse. The aim of this study is to investigate whether CET as aftercare increases the efficiency of Cognitive Behavioural Therapy (CBT) among AUD individuals. Design and methods: The study is implemented as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled AUD patients, recruited from an alcohol outpatient clinic will be randomized to one of the three following aftercare treatment groups: (A) CET as a smartphone application (n = 100); (B) CET as group therapy (n = 100), and (C) Aftercare as Usual (n = 100). It is hypothesized that the two experimental groups ((A) and (B)) will achieve better treatment outcomes as compared to the control group ((C)), and It will be explored whether CET as smartphone application is as effective as CET as group therapy. The groups will be compared in a number of parameters including alcohol intake, cravings and copings-strategies. Discussion: If the hypothesis, that CET increases the efficiency of CBT is verified, it will make sense to supplement CBT with CET as aftercare, hence, reintegrating CET within a CBT approach. Although, CET is most often regarded as one of the behavioral methods in CBT, there appears to be segregation in the empirical literature when it comes to treatment of addictive disorders. However, CET may allow the patient to practice and gain control over alcohol cue reactivity and associated high-risk situations in an inter-mediating therapeutic context before the patients inevitably are confronted by them. In this way, one might expect the transition from treatment to daily life less overwhelming and CET may help prevent relapse in the long term. Thus, CET may be particularly suitable as aftercare.

NCT ID: NCT02275611 Completed - Alcohol Dependence Clinical Trials

Oxytocin Treatment of Alcohol Dependence

OT-ETOH2
Start date: January 2013
Phase: Phase 2
Study type: Interventional

This study will test in individuals who have alcohol dependence (alcohol addiction) the hypotheses 1) that intranasal oxytocin treatment will decrease withdrawal symptoms during medical detoxification and 2) that intranasal oxytocin treatment for 12 weeks in the outpatient setting will decrease drinking.

NCT ID: NCT02272023 Completed - Clinical trials for Alcohol Use Disorders

Randomized Trial of Intensive Motivational Interviewing (IMI) to Improve Drinking Outcomes Among Women

Start date: February 2015
Phase: N/A
Study type: Interventional

A Phase II Randomized Clinical Trial (RCT) is proposed to compare a 9-session model of intensive motivational interviewing (IMI) to standard motivational interviewing techniques (SMI) among alcohol dependent women. Preliminary work studying 87 women randomly assigned to IMI or a standard single session of motivational interviewing showed significantly better drinking outcomes for women in the IMI condition at 4- and 6-month follow-up. Interestingly, mean trajectories for women assigned to IMI showed continuing declines in drinking problems during and after treatment. Differences between study conditions grew larger between 4-month (p<.05) and 6-month (p<.01) follow-up and the effect size at 6 months was medium to large (Cohen's d=0.63) The study will use mixed model quantitative and qualitative methods to respond to the PA's call for studies assessing mechanisms of change. Unlike many previous studies of SMI, we will employ limited exclusion criteria and will enroll participants who present with co-existing drug and psychiatric disorders. Procedures for the proposed study draw from our current successful RCT assessing IMI for methamphetamine (MA) dependence. Successful aspects of the current study include achievement of recruitment goals, strong adherence to the treatment and research protocols, and excellent rates for follow-up interviews (>90%). The proposed study will take place at the same outpatient treatment program as the current study, New Leaf Treatment Center in Lafayette, California. Participants will include 220 alcohol dependent women who will be randomly assigned to IMI or SMI. Those in SMI will also receive an attention component (nutrition education) to achieve time equivalence between the two study conditions. Participants in both groups will receive standard weekly group treatment offered at the program. In addition, referrals to Alcoholics Anonymous will be provided to all participants. The primary outcomes will be measures of drinking, heavy drinking (4+ drinks), and severity of alcohol problems assessed at baseline and 2, 6, and 12 months. Secondary outcomes will include Addiction Severity Index scales, psychiatric problems, and symptoms of trauma. The study will include standard quantitative testing of potential mediators, including, the therapeutic alliance, self-efficacy, motivation, satisfaction, and use of outside services. However, the application also proposes an innovative use of qualitative procedures to identify unrecognized factors influencing outcome.

NCT ID: NCT02262026 Completed - Alcoholism Clinical Trials

The Tolerability and Effects of AZD0530 in Individuals With or Without a Family History of Alcoholism

Start date: November 1, 2014
Phase: Phase 1
Study type: Interventional

Functional neuroimaging of alcoholism vulnerability: glutamate, reward, impulsivity, and Pavlovian-to-instrumental transfer (PIT), part II Saracatinib

NCT ID: NCT02251912 Completed - Alcohol Dependence Clinical Trials

Oxytocin Treatment of Alcohol Dependence

OTS ETOH-3
Start date: July 2015
Phase: Phase 2
Study type: Interventional

Purpose: Test whether oxytocin treatment decreases symptoms of withdrawal from alcohol and decreases drinking in people who have been consuming alcohol heavily for long periods and are physically and psychologically dependent on (addicted to) alcohol. Participants: 50 adults with alcohol dependence Procedures (methods): Oxytocin or placebo will be administered three times a day for the first 2 days of the 12 week period, followed by twice daily intranasal sprays for the rest of the 12 weeks. Before, during and at the end of the trial, each subject will undergo evaluations including breathalyzer readings, rating withdrawal symptoms, interviews about amount of alcohol consumed since last clinic visit, subject self-ratings of anxiety, alcohol craving and, at some visits, laboratory measures (blood and urine) to monitor safety and alcohol/drug use. Following the active phase of the trial, subjects will be followed up at 4 weeks and 12 weeks to evaluate for post-medication safety and efficacy