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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study

Study Primary Completion Date: July 2008

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(s) in this Clinical Trial

• Drug: Venlafaxine (Effexor XR)
  • 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.
• Behavioral: 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.
• Other: Placebo medication and relaxation training
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 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.
• Placebo Comparator: 2
  • 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 placebo.

Primary Measures

• Drinking status over the course of treatment and during the treatment follow-up
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• Treatment completion
  • Time Frame: 12 months
    Safety Issue?: No
• Remission rates
  • Time Frame: 12 months
    Safety Issue?: No
• Anxiety-disorder free rates
  • Time Frame: 12 months
    Safety Issue?: No
• Abstinence rates
  • Time Frame: 12 months
    Safety Issue?: No
• Drinking frequency
  • Time Frame: 12 months
    Safety Issue?: No

Inclusion Criteria:

• Participants must be English-speaking males or females
• Participants must be between 18 and 65 years old
• Meet criteria for DSM-IV diagnosis of alcohol abuse or dependence
• Meet criteria for Panic disorder, Social Phobia or Generalized Anxiety Disorder
• Physically able to attend sessions at the Counseling Center
• Able to read and write
• Able to complete the structured interview and self-report assessment packet
• Able to attend all treatment sessions and follow-up assessments
• Able to sign a witnessed informed consent form
• Participants express a desire to completely stop drinking alcohol or reduce alcohol consumption with the possible long-term goal of abstinence

Exclusion Criteria:

• Meet DSM-IV diagnostic criteria for bipolar disorder, schizophrenia, bulimia/anorexia, or dementia
• Currently taking anti-craving agents (e.g. Naltrexone, methadone)
• Currently taking medication that has clinically significant interactions with venlafaxine
• Previous use of venlafaxine
• Currently taking other antidepressant medications
• Currently taking medication known to decrease anxiety or alcohol consumption (e.g.
• antabuse)
• Currently prescribed medications with known abuse potential (e.g., subjects on opioid agonist therapy)
• Currently prescribed medications as a sleep aid (e.g. Ambien)
• Currently taking herbal supplements that have been shown to interact with venlafaxine or affect anxiety symptoms
• Currently pregnant, breastfeeding, plans of becoming pregnant during the course of the study, or not using medically acceptable form of birth control (oral contraceptives, barrier [diaphragm or condom] with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection).
• Planning to relocate out-of-state within four months of protocol initiation
• History of psychotic symptoms within the past 30 days
• Experiencing severe symptoms of depression or have engaged in suicidal behaviors within the past 30 days
• Medical contraindications to the use of venlafaxine [severe renal disease, cirrhosis, uncontrolled blood pressure, recent cardiovascular problems (e.g., heart attack), and seizure disorders; currently taking a monoamine oxidase inhibitor, MAOI]
• Self-reported anxiety less than 15 on the Hamilton Rating Scale for Anxiety
• Participant is a member of the same household of another subject already participating in the study
• Participant is legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in an alcohol treatment program
• Participant has a current or recent (past 30 days) DSM-IV diagnosis of other substance abuse or dependence, with the exception of nicotine, marijuana, and caffeine

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Overall Clinical Trial Officials and Contacts

Todd J. Farchione, PhD Study Director Center for Anxiety and Related Disorders at Boston University  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00248612

Study ID Number: NIAAACIR013727

ClinicalTrials.gov Identifier: NCT00248612

Health Authority: United States: Federal Government