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Psychosocial and Medication Treatment for Anxiety in Alcoholism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248612
First Posted: November 4, 2005
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Boston Medical Center
  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 Behavioral: CBT Other: Progressive muscle relaxation therapy (PMR) Other: Placebo medication Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBT And Venlafaxine Treatments For Anxiety In Alcoholism

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Clinical Global Impression Scale-I (CGI-I) [ Time Frame: Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) ]

    Global improvement of alcohol dependence: Rate the total improvement in the participant's alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed?

    (1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse)


  • Clinical Global Impression Scale-S (CGI-S) [ Time Frame: 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) ]

    Global severity of alcohol dependence: Considering your total clinical experience with the alcohol dependent population how severe are his/her alcohol dependence symptoms at this time?

    (1-Normal, no symptoms, 2-Borderline symptoms, 3-Mild symptoms, 4-Moderate symptoms, 5-Marked symptoms, 6-Severe symptoms, 7-Among the most extreme symptoms)


  • Craving Desire Scale (CDS) [ Time Frame: 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) ]
    The Craving Desire Scale (CDS) is a 3-item scale ("1. I do want to drink now", "2. I crave a drink right now", 3. "I have a desire for a drink right now") used to identify the degree of current alcohol craving, with responses provided on a Likert scale of 1-7: with 1 meaning strongly disagree, and 7 meaning strongly agree to each of the 3 items. Total scores can range from 3 to 21 with higher scores indicating greater craving for alcohol.

  • Number of Participants Abstinent [ Time Frame: Session 8 (8 weeks of treatment) ]
    Abstaining from the consumption of intoxicating beverages.


Secondary Outcome Measures:
  • Treatment Completion [ Time Frame: 12 months ]
    The number and percent of participants that completed the treatment in each arm of the study.

  • Medication Compliance Rates [ Time Frame: 12 months ]
    The medication compliance rate is the percentage of participants in each study arm who took their medication based on pill counts.

  • DASS Stress Subscale Score [ Time Frame: Session 1 (baseline), Session 11 (11 weeks of treatment) ]
    DASS (Depression Anxiety Stress Scales) assesses depression, anxiety and stress responses. Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. The stress subscale was used which assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Stress scores can range form 0-56 with 0-14=normal, 15-18=mild, 19-25=moderate, 26-33=severe. and 34+=extremely severe stress.

  • HAM-A Scale [ Time Frame: Session 1 (baseline), Session 8 (8 weeks of treatment) ]
    The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. The HAM-A probes 14 parameters each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. total scores can range from 0 to 56.where <17 indicates mild anxiety, 18-24 moderate anxiety and 25-30 severe anxiety. Higher scores reflect more anxiety.

  • HAM-D Scale [ Time Frame: Session 1 (baseline), Session 8 (8 weeks of treatment) ]
    HAM-D (Hamilton Rating Scale for Depression) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The scoring is based on 17 items. Eight of the items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored on a 3 point scale from 0-2 where 0=none or absent and 2= severe. The total scores for the HAM-D can range from 0 to 50. The total scores are interpreted as: 0-7=normal, 8-13=mild, 14-18= moderate, 19-22= severe, and 23+=very severe depression. The higher the score the more severe the participant's depression.


Enrollment: 162
Actual Study Start Date: September 2003
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venlafaxine & CBT
CBT is Cognitive Behavioral Treatment which will be tailored to participants. 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.
Drug: Venlafaxine
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.
Other Name: Effexor XR
Behavioral: CBT
CBT is 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.
Active Comparator: Placebo & CBT
CBT is Cognitive Behavioral Treatment which will be tailored to participants.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.
Behavioral: CBT
CBT is 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
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.
Active Comparator: Venlafaxine & PMR
Progressive Muscle Relaxation Therapy (PMR) is a technique of alternately tensing and relaxing muscles groups in sequence throughout the body. . 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.
Drug: Venlafaxine
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.
Other Name: Effexor XR
Other: Progressive muscle relaxation therapy (PMR)
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.
Placebo Comparator: Placebo & PMR
Progressive Muscle Relaxation Therapy (PMR) is a technique of alternately tensing and relaxing muscles groups in sequence throughout the body. . For patients with co-morbid 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.
Other: Progressive muscle relaxation therapy (PMR)
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.
Other: Placebo medication
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:

  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?
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248612


Locations
United States, Massachusetts
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston Medical Center
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

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00248612     History of Changes
Other Study ID Numbers: H-22529
R01AA013727-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 2, 2005
First Posted: November 4, 2005
Results First Submitted: May 24, 2017
Results First Posted: August 17, 2017
Last Update Posted: September 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Boston Medical Center:
Venlafaxine
Alcoholism
Anxiety Disorders
Alcohol-Use Disorders
Alcohol Abuse
Alcohol Dependence
Cognitive Behavioral Treatment

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Alcoholism
Alcohol-Related Disorders
Pathologic Processes
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Venlafaxine Hydrochloride
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs