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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA012602 | 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 purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence.
This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to which acamprosate and naltrexone will suppress subjective and physiological responsivity to alcohol cues relative to placebo in early abstinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Acamprosate |
|
| 2 | Active Comparator | Naltrexone |
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| 3 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acamprosate | Drug | Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period | The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Standard Drinks Per Week at 1 Week | Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol. | 1 week |
| Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1 |
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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 | La Jolla | California | 92037 | United States |
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Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, California from 04/17/2008-12/10/2009. Sixty eight subjects were enrolled, and sixty two subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Campral (Acamprosate) | Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration |
| FG001 | ReVia (Naltrexone) | Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration |
| FG002 | Sugar Pill (Placebo) | Placebo: Double-dummy placebo capsules, 1 week duration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Campral (Acamprosate) | Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration |
| BG001 | ReVia (Naltrexone) | Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration |
| 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 | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period | The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
Adverse event data was collected at all four study visits, an average duration of 4 weeks.
Adverse events, both serious and other, were documented at all four 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 | Acamprosate | Acamprosate Acamprosate: Total dose, 1998 mg daily, 1 week duration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara J. Mason, Ph.D.-Principal Investigator | The Scripps Research Institute | 858784-7328 | 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 |
|---|---|
| D000077443 | Acamprosate |
| D009271 | Naltrexone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D013654 | Taurine |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| Naltrexone | Drug | 50mg capsule, Once daily, 1 week duration |
|
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| Placebo | Drug | Matched placebo capsule, 1 week duration |
|
|
The BDI-II is a self-rating of severity of depressive symptoms. BDI-II Total scores range from 0-63; a lower score indicates less severe depressive systems and thus is a better outcome. Change = (Week 1 score - Baseline score). The Total score is a sum of the 21 items on the BDI-II instrument, with each item rated from 0-3. |
| 1 week |
| Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1 | The PSQI is an instrument to assess subjective sleep quality and disturbance. The Total score ranges from 0 to 21 where a lower score is better sleep quality. Change = (Week 1 score - Baseline score). Seven subscales (range 0-3) are summed to compute the Total score. | 1 week |
| Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1 | The ACQ-SF is an assessment of current drinking urges, difficulty resisting urge and anticipation of positive outcome or relief from negative state by drinking. The Total score ranges from 0 to 7 where a lower score is a better outcome. Change = (Week 1 score - Screening score). The scale is comprised of twelve items (range 0-7) that are averaged to compute the Total score. | 2 weeks |
| BG002 | Sugar Pill (Placebo) | Placebo: Double-dummy placebo capsules, 1 week duration |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration |
| OG002 | Sugar Pill (Placebo) | Placebo: Double-dummy placebo capsules, 1 week duration |
|
|
| Secondary | Change From Baseline in Standard Drinks Per Week at 1 Week | Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol. | Posted | Mean | Standard Deviation | drinks/week | 1 week |
|
|
|
| Secondary | Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1 | The BDI-II is a self-rating of severity of depressive symptoms. BDI-II Total scores range from 0-63; a lower score indicates less severe depressive systems and thus is a better outcome. Change = (Week 1 score - Baseline score). The Total score is a sum of the 21 items on the BDI-II instrument, with each item rated from 0-3. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1 | The PSQI is an instrument to assess subjective sleep quality and disturbance. The Total score ranges from 0 to 21 where a lower score is better sleep quality. Change = (Week 1 score - Baseline score). Seven subscales (range 0-3) are summed to compute the Total score. | Seven participants who completed the double blind portion of the trial were unable to be analyzed for change in PSQI Total score due to incomplete PSQI questionnaire at baseline and/or Week 1. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1 | The ACQ-SF is an assessment of current drinking urges, difficulty resisting urge and anticipation of positive outcome or relief from negative state by drinking. The Total score ranges from 0 to 7 where a lower score is a better outcome. Change = (Week 1 score - Screening score). The scale is comprised of twelve items (range 0-7) that are averaged to compute the Total score. | One participant in the naltrexone arm who completed the double blind portion of the trial was unable to be analyzed for change in ACQ-SF Total score due to incomplete ACQ-SF questionnaire at Week 1. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | Naltrexone | Naltrexone Naltrexone: 50mg capsule, Once daily, 1 week duration | 0 | 25 | 9 | 25 |
| EG002 | Placebo | Placebo: Double-dummy placebo capsules, 1 week duration | 0 | 17 | 3 | 17 |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Diaherrea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Decreased libido | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |
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| Drinks/week Change |
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| BDI-II Total Change |
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| PSQI Total Change |
|
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| ACQ-SF Total Change |
|