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The overall goals of this study are to (1) expand knowledge about interactions of chlorzoxazone with alcohol by assessing the effects of chlorzoxazone compared to placebo in moderate and heavy social alcohol users and (2) to compare the effects of chlorzoxazone on visual cue induced alcohol craving to placebo in moderate to heavy social alcohol users.
The investigators propose a 45-day, double-blind, placebo-controlled crossover study in light to moderate and heavy alcohol users.
The specific aims are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parafon Forte first, then Placebo | Experimental | Experimental: Forty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (1st intervention; 14 days), followed by a washout (7 days), and then followed by placebo (2nd intervention; 14 days). |
|
| Placebo first, then Parafon Forte | Placebo Comparator | Experimental: Forty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive placebo (1st intervention; 14days) followed by a washout (7 days), and then followed by either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (2nd intervention; 14 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parafon Forte | Drug | Drug: Parafon Forte administered at study visit Other: Placebo administered at study visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Consumption in Drinks/Week. | Each subject will record how many drinks/week they are consuming while on the study drug and placebo during the 45-day study. The primary outcome of this study is to determine the effect of chlorzoxazone on alcohol consumption. Reduction in alcohol consumption is measured utilizing behavioral inventories, electronic diaries, urine, and ethyl glucuronide. | 45 days |
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Inclusion Criteria:
Inclusion Criteria: Healthy adults who are social drinkers 21 - 50 years of age.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Fields, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ernest Gallo Clinic and Research Center | Emeryville | California | 94608 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parafon Forte First, Then Placebo | Participants will receive either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (1st intervention; 14 days), followed by a washout (7 days), and then followed by placebo (2nd intervention; 14 days). |
| FG001 | Placebo First, Then Parafon Forte | Participants will receive placebo (1st intervention; 14days) followed by a washout (7 days), and then followed by either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (2nd intervention; 14 days). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Parafon Forte First, Then Placebo | Participants will receive either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (1st intervention; 14 days), followed by a washout (7 days), and then followed by placebo (2nd intervention; 14 days). |
| BG001 |
| 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 | Alcohol Consumption in Drinks/Week. | Each subject will record how many drinks/week they are consuming while on the study drug and placebo during the 45-day study. The primary outcome of this study is to determine the effect of chlorzoxazone on alcohol consumption. Reduction in alcohol consumption is measured utilizing behavioral inventories, electronic diaries, urine, and ethyl glucuronide. | Posted | Mean | Standard Deviation | number of drinks | 45 days |
|
From enrollment through study completion, up to 45 days
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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 | Parafon Forte | This is a cross-over study. Adverse Events Arms/Groups are reported "per intervention". Group reflects **all** participants who received Parafon Forte intervention during the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Mitchell, Clinical Project Director | Ernest Gallo Clinic and Research Center | 510-985-3921 | jmitchell@gallo.ucsf.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 |
|---|---|
| D002753 | Chlorzoxazone |
| ID | Term |
|---|---|
| D001583 | Benzoxazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo First, Then Parafon Forte |
Participants will receive placebo (1st intervention; 14days) followed by a washout (7 days), and then followed by either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (2nd intervention; 14 days). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received placebo (1st intervention; 14 days) followed by a washout (7 days), and then followed by either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (2nd intervention; 14 days). |
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Placebo | This is a cross-over study. Adverse Events Arms/Groups are reported "per intervention". Group reflects **all** participants who received Placebo intervention during the study. | 0 | 48 | 0 | 48 | 0 | 48 |
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