Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248612
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2005-11-02
Brief Title:
Psychosocial and Medication Treatment for Anxiety in Alcoholism
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
CBT And Venlafaxine Treatments For Anxiety In Alcoholism
Status:
COMPLETED
Status Verified Date:
2018-01
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:
The proposed project is written as a typical clinical practice test and is a fully-controlled trial of a combined anxiety-focused CBT and pharmacotherapy venlafaxine CBT-VEN delivered for patients with comorbid alcohol-use and anxiety disorders The CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication One hundred and eighty participants will be recruited and subsequent to a platform of outpatient treatment for alcoholism will be randomly assigned to a 12-week treatment condition All treatment conditions will begin with a 1-week placebo run-in after which participants will begin a trial of venlafaxine or placebo The treatments will conclude with a 2-week medicationplacebo taper Follow-up assessments will be conducted at post-treatment and at 3 6 9 and 12-months The long-term objectives of this research are to develop a real-world combination of psychosocial and pharmacological treatments for patients with comorbid alcohol-use and anxiety disorders that compromise prognosis and to evaluate the effectiveness of combined psychosocial and pharmacological treatments that target anxiety among patients with this comorbidity
Detailed Description:
Difficulties in anxiety management are frequent causes of relapse to alcohol use Empirical data support the role of anxiety in alcohol relapse and both psychosocial and pharmacological treatments for alcohol problems increasingly address the role of negative affect in alcohol-use disorders Due to the lack of large well-controlled treatment outcome trials the optimal treatment or combination of treatments remains unknown Real world practice in the treatment of alcohol-use disorders frequently begins with brief detoxification and stabilization and is often followed by some combination of CBT and pharmacotherapy for patients complaining of mood difficulties while attempting early abstinence from alcohol
The purpose of the present study is to evaluate the relative benefits of psychosocial and psychopharmacological therapy for the treatment of co-morbid anxiety and alcohol dependence among patients attempting early abstinence from alcohol We will address the following four questions
1 During the course of intervention is treatment of anxiety disorders with combined treatments of established utility among non-alcohol-use-disordered patients superior in managing both return to drinking and anxiety symptoms than either monotherapy or a fully inactive control treatment
2 During the follow-up period will patients who received the combined active treatments fare better in maintaining abstinence relative to the single active treatments and those in the control condition
3 What psychosocial variables such as increases or lapses to elevated anxiety mediate return to pre-treatment levels of alcohol use
4 Will baseline indices of alcohol dependence and anxiety disorder severity moderate the relationship between treatment and outcome during both the acute and follow-up phases of the study
The purpose of the present study is to evaluate the relative benefits of psychosocial and psychopharmacological therapy for the treatment of co-morbid anxiety and alcohol dependence among patients attempting early abstinence from alcohol We will address the following four questions
1 During the course of intervention is treatment of anxiety disorders with combined treatments of established utility among non-alcohol-use-disordered patients superior in managing both return to drinking and anxiety symptoms than either monotherapy or a fully inactive control treatment
2 During the follow-up period will patients who received the combined active treatments fare better in maintaining abstinence relative to the single active treatments and those in the control condition
3 What psychosocial variables such as increases or lapses to elevated anxiety mediate return to pre-treatment levels of alcohol use
4 Will baseline indices of alcohol dependence and anxiety disorder severity moderate the relationship between treatment and outcome during both the acute and follow-up phases of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA013727-01A1 | NIH | None | httpsreporternihgovquickSearchR01AA013727-01A1 |