Psychosocial and Medication Treatment for Anxiety in Alcoholism
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Alcohol-Related Disorders, Anxiety Disorders
In brief
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.
Key facts
- Study ID
- NCT00248612
- Run by
- Boston Medical Center
- People needed
- 162
- Starts
- 2003-09-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2018-01-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Boston Medical Center — Boston, Massachusetts, United States
- Center for Anxiety and Related Disorders — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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