Status:
COMPLETED
Psychosocial and Medication Treatment for Anxiety in Alcoholism
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol-Related Disorders
Anxiety Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 patient...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00248612
Start Date
September 1 2003
End Date
March 1 2009
Last Update
January 24 2018
Active Locations (2)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118
2
Center for Anxiety and Related Disorders
Boston, Massachusetts, United States, 02215