Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352469
Status:
COMPLETED
Last Update Posted:
2008-12-08
First Post:
2006-07-12
Brief Title:
Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
12 Week Prospective Double Blind Placebo Controlled Randomized Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alcohol use disorders AUDs are a major problem facing our society Their treatment is complex and involves multiple behavioral and pharmacotherapy interventions There are 3 approved medications for AUDs but their efficacy for AUDs that co-exist with anxiety disorders is unknown This study explores the effects of the medication sustained-release quetiapine fumarate Seroquel SR for the treatment of alcohol dependence and co-morbid anxiety Primary outcome measure is the amount of alcohol used Secondary outcome measures include craving for alcohol length of sobriety from drinking and level of anxiety with Seroquel SR
Detailed Description:
STUDY OBJECTIVES
The objective of this proposal is to study the efficacy of the medication Seroquel SR for the treatment of alcohol dependence and co-morbid anxiety in a prospective double blind placebo-controlled randomized clinical study Patients meeting the DSM-IV criteria for Alcohol Dependence and an Anxiety Disorder will be enrolled and randomized to receive placebo or Seroquel SR All subjects will be referred to usual treatment program where they can receive groupself help group therapy
Method
This is a 12-week prospective double blind placebo-controlled randomized clinical trial of Seroquel SR in patients who meet the Diagnostic and Statistical Manual of Psychiatric Disorders DSM-IV criteria for alcohol dependence and anxiety disorders Potential candidates will be allowed sufficient time to review the consent document and ask questions about the trial prior to signing the consent document Consenting adults will be randomized to receive active medication Seroquel SR or placebo for 12-weeks The study will enroll 20 patients 10 will be randomized to receive Seroquel SR and 10 will receive placebo All participants will also be referred to usual alcohol treatment including individual group andor self help group therapy Alcoholics Anonymous
Subjects will be randomized to receive either Seroquel SR or placebo Dosing of Seroquel SR will occur on the following schedule At the baseline visit Seroquel SR will be started at 50 mg QHS for Day 1 and 2 and dose increase to 150 mg QHS on day 3-4 and increased further to 300 mg QHS from day 5-day 42 After day 5 the Seroquel SR dosage can be increased by up to 100 mg per week to a maximal dose of 400 mg per day During the treatment period dose reductions because of physical illness or adverse event are allowed for patients taking at least 200 mg per day
The objective of this proposal is to study the efficacy of the medication Seroquel SR for the treatment of alcohol dependence and co-morbid anxiety in a prospective double blind placebo-controlled randomized clinical study Patients meeting the DSM-IV criteria for Alcohol Dependence and an Anxiety Disorder will be enrolled and randomized to receive placebo or Seroquel SR All subjects will be referred to usual treatment program where they can receive groupself help group therapy
Method
This is a 12-week prospective double blind placebo-controlled randomized clinical trial of Seroquel SR in patients who meet the Diagnostic and Statistical Manual of Psychiatric Disorders DSM-IV criteria for alcohol dependence and anxiety disorders Potential candidates will be allowed sufficient time to review the consent document and ask questions about the trial prior to signing the consent document Consenting adults will be randomized to receive active medication Seroquel SR or placebo for 12-weeks The study will enroll 20 patients 10 will be randomized to receive Seroquel SR and 10 will receive placebo All participants will also be referred to usual alcohol treatment including individual group andor self help group therapy Alcoholics Anonymous
Subjects will be randomized to receive either Seroquel SR or placebo Dosing of Seroquel SR will occur on the following schedule At the baseline visit Seroquel SR will be started at 50 mg QHS for Day 1 and 2 and dose increase to 150 mg QHS on day 3-4 and increased further to 300 mg QHS from day 5-day 42 After day 5 the Seroquel SR dosage can be increased by up to 100 mg per week to a maximal dose of 400 mg per day During the treatment period dose reductions because of physical illness or adverse event are allowed for patients taking at least 200 mg per day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None