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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA013727-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venlafaxine & CBT | Experimental | 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. |
|
| Placebo & CBT | Active Comparator | 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. |
|
| Venlafaxine & PMR | Active Comparator | 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. |
|
| Placebo & PMR | Placebo Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venlafaxine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale-I (CGI-I) | 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) | Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) |
| Clinical Global Impression Scale-S (CGI-S) | 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) | 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) |
| Craving Desire Scale (CDS) | 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. | 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) |
| Number of Participants Abstinent | Abstaining from the consumption of intoxicating beverages. | Session 8 (8 weeks of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Completion | The number and percent of participants that completed the treatment in each arm of the study. | 12 months |
| Medication Compliance Rates | The medication compliance rate is the percentage of participants in each study arm who took their medication based on pill counts. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Domenic Ciraulo, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| Center for Anxiety and Related Disorders |
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Once subjects achieved the four day period of abstinence they completed a second baseline assessment in which eligibility was re-assessed. 81 Eligible subjects were then randomized into the four study arms.
Following telephone screening (n=950), 162 eligible subjects completed an in-clinic baseline assessment #1 to determine eligibility for inclusion in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Venlafaxine & CBT | 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. They will also receive tailored cognitive behavioral training (CBT) |
| FG001 | Placebo & CBT | Placebo and CBT (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. |
| FG002 | Venlafaxine & PMR | Venlafaxine and PMR (progressive muscle relaxation therapy). |
| FG003 | Placebo & PMR | Placebo medication and PMR (progressive muscle relaxation therapy) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Venlafaxine & CBT | Venlafaxine (Effexor XR) and CBT (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 of venlafaxine. The treatments will conclude with a 2-week medication taper. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Global Impression Scale-I (CGI-I) | 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) | Posted | Mean | Standard Deviation | units on a scale | Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Venlafaxine & CBT | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suicidal ideation | Psychiatric disorders | Systematic Assessment |
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Small size of treatment groups leading to diminished meaningful difference between comparison groups at follow-up; Failure of randomization leading to unequal number of subjects in each treatment group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd J. Farchione, PhD | Center for Anxiety and Related Disorders at Boston University | 617 353 9610 | tfarchio@bu.edu |
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| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D001008 | Anxiety Disorders |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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|
|
| CBT | Behavioral | 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. |
|
| Progressive muscle relaxation therapy (PMR) | Other | 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 medication | Other | 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. |
|
| 12 months |
| DASS Stress Subscale Score | 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. | Session 1 (baseline), Session 11 (11 weeks of treatment) |
| HAM-A Scale | 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. | Session 1 (baseline), Session 8 (8 weeks of treatment) |
| HAM-D Scale | 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. | Session 1 (baseline), Session 8 (8 weeks of treatment) |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| BG001 |
| Placebo & CBT |
Placebo and CBT (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. |
| BG002 | Venlafaxine & PMR | Venlafaxine and PMR (progressive muscle relaxation therapy). |
| BG003 | Placebo & PMR | Placebo medication and PMR (progressive muscle relaxation therapy) |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Drinking status | Drinking status was measured for the 90 day long pre-screening period by calculating the mean percent and standard deviation of the days drinking and of the days heavy drinking | Mean | Standard Deviation | percent of days |
|
| ADS Scores | The ADS provides a quantitative measure of the severity of alcohol dependence consistent with the concept of the alcohol dependence syndrome. The 25 items cover alcohol withdrawal symptoms, impaired control over drinking, awareness of a compulsion to drink, increased tolerance to alcohol, and salience of drink-seeking behavior. Scores range from 0-47.0= no alcohol dependence, 1-13=low, 14-21 =intermediate, 22-30= substantial and 31-47= severe level of alcohol dependence. | Mean | Standard Deviation | units on a scale |
|
| Drinks per day | The average number of drinks per day was obtained by taking the mean of the number of drinks each day for the 90 day long pre-screening period. | Mean | Standard Deviation | number of drinks |
|
| OG001 | Placebo & CBT | Placebo and CBT (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. |
| OG002 | Venlafaxine & PMR | Placebo medication and PMR (progressive muscle relaxation therapy). |
| OG003 | Placebo & PMR | Placebo medication and PMR (progressive muscle relaxation therapy) |
|
|
| Primary | Clinical Global Impression Scale-S (CGI-S) | 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) | Posted | Mean | Standard Deviation | units on a scale | 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) |
|
|
|
| Primary | Craving Desire Scale (CDS) | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment) |
|
|
|
| Primary | Number of Participants Abstinent | Abstaining from the consumption of intoxicating beverages. | Posted | Count of Participants | Participants | Session 8 (8 weeks of treatment) |
|
|
|
| Secondary | Treatment Completion | The number and percent of participants that completed the treatment in each arm of the study. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Medication Compliance Rates | The medication compliance rate is the percentage of participants in each study arm who took their medication based on pill counts. | Posted | Number | percentage of participants | 12 months |
|
|
|
| Secondary | DASS Stress Subscale Score | 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Session 1 (baseline), Session 11 (11 weeks of treatment) |
|
|
|
| Secondary | HAM-A Scale | 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Session 1 (baseline), Session 8 (8 weeks of treatment) |
|
|
|
| Secondary | HAM-D Scale | 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Session 1 (baseline), Session 8 (8 weeks of treatment) |
|
|
|
| 0 |
| 24 |
| 3 |
| 24 |
| 0 |
| 24 |
| EG001 | Placebo & CBT | Placebo and CBT (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. | 0 | 21 | 1 | 21 | 0 | 21 |
| EG002 | Venlafaxine & PMR | Venlafaxine medication and PMR (progressive muscle relaxation therapy). | 0 | 14 | 2 | 14 | 0 | 14 |
| EG003 | Placebo & PMR | Placebo medication and PMR (progressive muscle relaxation therapy) | 0 | 22 | 1 | 22 | 0 | 22 |
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| insomnia | General disorders | Systematic Assessment |
|
| agitation/restlessness | Psychiatric disorders | Systematic Assessment |
|
| depression | Psychiatric disorders | Systematic Assessment |
|
| anxiety | Psychiatric disorders | Systematic Assessment |
|
| elevated blood pressure | General disorders | Systematic Assessment |
|
| profuse sweating | General disorders | Systematic Assessment |
|
| vertigo | General disorders | Systematic Assessment |
|
Not provided
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| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
| Session 8 CGI-S |
|
| Session 11 CGI-S |
|
| Session 8 CDS |
|
| Session 11 CDS |
|
| Session 11 DASS stress subscale |
|
| Session 8 HAM-A |
|
| Session 8 HAM-D |
|