Psychosocial and Medication Treatment for Anxiety in Alcoholism
Condition: Alcohol-Related Disorders; Anxiety Disorders
MeSH terms: Alcoholism; Alcohol-Related Disorders; Anxiety Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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?
    

Intervention name(s): Venlafaxine; CBT; Progressive muscle relaxation therapy (PMR); Placebo medication
Intervention type(s): Drug; Behavioral; Other; Other
Intervention description(s): Participants will be 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. The treatments will conclude with a 2-week medication taper.; CBT is Cognitive Behavioral Therapy. Participants will be 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. The treatments will conclude with a 2-week medication/placebo taper.; For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.; For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.
Other intervention name(s): Effexor XR
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Venlafaxine; Alcoholism; Anxiety Disorders; Alcohol-Use Disorders; Alcohol Abuse; Alcohol Dependence; Cognitive Behavioral Treatment