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| ID | Type | Description | Link |
|---|---|---|---|
| R37AA014028 | U.S. NIH Grant/Contract | View source | |
| MERIT |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d, duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and follow-up visits 1 week and 3 months post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental |
| |
| Pregabalin | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12 | Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. | Baseline and Week 12 |
| Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12 | Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. | Baseline and Week 12 |
| Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12 | Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J Mason, Ph.D. | The Scripps Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research | La Jolla | California | 92037 | United States |
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| Label | URL |
|---|---|
| Study Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine | Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration. |
| FG001 | Pregabalin | Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration. |
| FG002 | Placebo | Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine | Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12 | Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. | Posted | Mean | Standard Deviation | drinks/week | Baseline and Week 12 |
|
Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24.
Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.
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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 | Duloxetine | Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara J. Mason, Ph.D. | The Scripps Research Institute | 858-784-7328 | mason@scripps.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Duloxetine | Drug | 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. |
|
|
| Standardized behavioral therapy | Behavioral | Standardized behavioral therapy 1 time per week for 12 week duration. |
|
|
| Standardized behavioral therapy | Behavioral | Standardized behavioral therapy 1 time per week for 12 week duration. |
|
|
| Placebo | Drug | Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. |
|
| Standardized behavioral therapy | Behavioral | Standardized behavioral therapy 1 time per week for 12 week duration. |
|
|
| Pregabalin |
Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration. |
| BG002 | Placebo | Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.
| OG002 | Placebo | Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration. |
|
|
| Primary | Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12 | Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. | Posted | Mean | Standard Deviation | drinking days/week | Baseline and Week 12 |
|
|
|
| Primary | Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12 | Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. | Posted | Mean | Standard Deviation | drinks/drinking day | Baseline and Week 12 |
|
|
|
| 2 |
| 50 |
| 43 |
| 50 |
| EG001 | Pregabalin | Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration. | 0 | 50 | 35 | 50 |
| EG002 | Placebo | Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration. | 4 | 50 | 33 | 50 |
| Chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gastrointestinal protozoal infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
| Drinking Days/Week Change |
|
|
| Drinks/Drinking Day Change |
|