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Alcoholism clinical trials

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NCT ID: NCT00010907 Withdrawn - Alcoholism Clinical Trials

Preliminary Human Trial of NPI-028

Start date: n/a
Phase: Phase 2
Study type: Interventional

This research will determine whether the Chinese herbal medicine (NPI-028) can make a significant contribution to the management of withdrawal and to follow-up treatment aimed at preventing or managing relapse in both women and men alcoholics. The herbal preparation has been used historically in the treatment of alcohol intoxication and is still prescribed in China and Southeast Asia. Efficacy has been documented but awaits the application of current research methods to establish efficacy, safety, and probable mechanisms of action. Preclinical studies have been carried out in alcohol-preferring rats and vervet monkeys to test efficacy in reducing voluntary alcohol intake, measure tolerance effects, and toxicological affects. The proposed human trial will develop a placebo, establish quality control, test methods of administration, and examine compliance issues. Following these preliminary steps, a placebo controlled trial will be conducted using 160 subjects (80 subjects per treatment condition with 40 of each gender). Alcohol use, craving, health status, psychological status, and at rates will be assessed using established measures that are current in addiction research.

NCT ID: NCT00006489 Completed - Alcoholism Clinical Trials

Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)

Start date: December 2000
Phase: Phase 4
Study type: Interventional

This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced medication management intervention will accompany all treatment conditions. Follow-up assessments will be completed at 9 and 12 months after treatment.

NCT ID: NCT00006449 Completed - Alcoholism Clinical Trials

Post-Treatment Effects of Naltrexone

Start date: September 2000
Phase: Phase 4
Study type: Interventional

The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level of cravings for alcohol.

NCT ID: NCT00006206 Completed - Alcoholism Clinical Trials

COMBINE (Acamprosate/Naltrexone)

Start date: August 1997
Phase: Phase 3
Study type: Interventional

Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the interventions will consist of pharmacological treatment with naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent behavioral therapy including such components as motivational enhancement therapy, cognitive behavioral therapy, and referral to self-help groups, including AA. All three interventions will include a component supporting compliance to medications and reduction in drinking.

NCT ID: NCT00006205 Recruiting - Alcoholism Clinical Trials

Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Start date: March 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.

NCT ID: NCT00006204 Completed - Depression Clinical Trials

Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)

Start date: March 2000
Phase: Phase 4
Study type: Interventional

This study will examine the effects of combing naltrexone and fluoxetine (Prozac) versus fluoxetine and placebo in alcoholics with co-occurring major depression. Both groups will actively participate in the 6-month study, which includes weekly individual Dual Disorders Recovery Counseling during the first month and every two weeks during the second through sixth months, plus the naltrexone and fluoxetine or fluoxetine and placebo. Subjects will complete follow-up assessments at 9 and 12 months.

NCT ID: NCT00006203 Completed - Alcoholism Clinical Trials

Naltrexone, Craving, and Drinking

Start date: n/a
Phase: Phase 4
Study type: Interventional

This 5-week study will examine the effects of naltrexone on alcohol craving, drinking rates, and reaction to drinking-related triggers, or cues, in participants' everyday environment and in laboratory sessions. Participants will monitor and record their daily desires to drink, environmental circumstances in which urges occur, and drinking behavior using a palm top computer. Participants will receive naltrexone or a placebo. One week after receiving medication, all participants will be asked to respond to alcohol-related cues that may or may not arouse the desire to drink.

NCT ID: NCT00004554 Completed - Depression Clinical Trials

Sertraline for Alcohol Dependence and Depression

Start date: January 2000
Phase: Phase 4
Study type: Interventional

This study will examine depressed alcoholic outpatients to assess whether combining naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking and depression over either medication alone or placebo. A secondary aim is to determine whether certain patient features will predict response to sertraline, naltrexone or the combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks. The followup phase includes two visits at 6 and 9 months after treatment.

NCT ID: NCT00004552 Completed - Alcoholism Clinical Trials

Acamprosate Treatment: Mechanisms of Action

Start date: n/a
Phase: Phase 2
Study type: Interventional

This study will examine whether pretreatment with two doses of acamprosate for seven days prior to abstinence lessens the intensity of acute withdrawal from alcohol compared with a placebo. Subjects will be randomly assigned to receive either one of two doses of acamprosate or placebo for seven days. This will be followed by a four- day inpatient period when withdrawal will be monitored. Additional drinking information will be obtained at a three month followup interview.

NCT ID: NCT00004551 Completed - Smoking Clinical Trials

Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

Start date: February 1999
Phase: Phase 4
Study type: Interventional

This study is to evaluate the effectiveness of a mood management intervention on abstinent alcoholic smokers with a history of major depression. The second aim is to determine the effect of smoking treatments on alcohol abstinence and to identify factors associated with smoking and alcohol outcomes (e.g., more days of abstinence). A randomized, two-group design will be used to evaluate the added benefit of mood management compared to a state-of-the-art smoking cessation treatment. Treatment will consist of 8 weekly group sessions and 1, 3, 6, and 12-month follow-up.