Anxiety Disorders Clinical Trial
Official title:
CBT And Venlafaxine Treatments For Anxiety In Alcoholism
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 medication/placebo 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.
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?
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