Psychosocial and Medication Treatment for Anxiety in Alcoholism
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
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
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Boston Medical Center Boston University
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)