Psychosocial and Medication Treatment for Anxiety in Alcoholism

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center; Boston University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Venlafaxine Hydrochloride

Criteria

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