Psychosocial and Medication Treatment for Anxiety in Alcoholism - Full Text View

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00248612

Purpose

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.

Condition	Intervention	Phase
Alcohol-Related Disorders Anxiety Disorders	Drug: Venlafaxine (Effexor XR) Behavioral: Cognitive Behavioral Therapy Other: Placebo medication and relaxation training	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	CBT And Venlafaxine Treatments For Anxiety In Alcoholism

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Alcoholism Anxiety

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Drinking status over the course of treatment and during the treatment follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Treatment completion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Remission rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Anxiety-disorder free rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Abstinence rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Drinking frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	September 2003
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.	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.
2: Placebo Comparator 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.	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

Assigned Interventions

1: Active Comparator

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.

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.

2: Placebo Comparator

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.

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.

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:

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?
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?
What psychosocial variables (such as increases or lapses to elevated anxiety) mediate return to pre-treatment levels of alcohol use?
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?

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248612

Locations

United States, Massachusetts
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Study Director:

Todd J. Farchione, PhD

Center for Anxiety and Related Disorders at Boston University

More Information

No publications provided

Responsible Party:	Center for Anxiety and Related Disorders at Boston University ( Todd J. Farchione, PhD )
Study ID Numbers:	NIAAACIR013727, NIH Grant R01 AA013727-01A1
Study First Received:	November 2, 2005
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00248612 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Venlafaxine
Alcoholism
Anxiety Disorders
Alcohol-Use Disorders

Alcohol Abuse
Alcohol Dependence
Cognitive Behavioral Treatment

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes

Anxiety Disorders
Mental Disorders
Therapeutic Uses
Alcoholism
Venlafaxine
Substance-Related Disorders
Alcohol-Related Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009