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The proposed protocol is an 8 week open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.
The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin | Experimental | pregabalin up to daily dose of 600 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | pregabalin up to 600 mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Dose of Pregabalin: | Defined as the highest amount of medication per day maintained for a 7 day period. | over the course of the 8 week trial or participants' length of participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| john mariani, md | new york psychiatric institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia Univeristy-STARS | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34092158 | Derived | Mariani JJ, Pavlicova M, Choi CJ, Brooks DJ, Mahony AL, Kosoff Z, Naqvi N, Brezing C, Luo SX, Levin FR. An open-label pilot study of pregabalin pharmacotherapy for alcohol use disorder. Am J Drug Alcohol Abuse. 2021 Jul 4;47(4):467-475. doi: 10.1080/00952990.2021.1901105. Epub 2021 Jun 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | pregabalin up to daily dose of 600 mg Pregabalin: pregabalin up to 600 mg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | pregabalin up to daily dose of 600 mg Pregabalin: pregabalin up to 600 mg/day |
| 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 | Maximum Dose of Pregabalin: | Defined as the highest amount of medication per day maintained for a 7 day period. | Data was available for 14 patients | Posted | Mean | Standard Deviation | milligrams | over the course of the 8 week trial or participants' length of participation |
|
|
Over the course of the 8 week trial or length of participant's participation
Data was collected for 15 participants with post-enrollment data
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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 | Pregabalin | pregabalin up to daily dose of 600 mg Pregabalin: pregabalin up to 600 mg/day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| drowsiness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Mariani MD | New York State Psychiatric Institute | 6467748181 | john.mariani@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2017 | Jul 17, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 28, 2017 | Jul 21, 2020 | Prot_001.pdf |
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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 |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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open label pilot study
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 12 |
| 15 |
| fogginess | General disorders | Systematic Assessment |
|
| dizziness | General disorders | Systematic Assessment |
|
| insomnia | General disorders | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| blurred vision | Eye disorders | Systematic Assessment |
|
| vivid dreams | General disorders | Systematic Assessment |
|
| dry mouth | General disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| difficulty concentrating | General disorders | Systematic Assessment |
|
| dry eyes | General disorders | Systematic Assessment |
|
| eye infection | Eye disorders | Systematic Assessment |
|
| increased sensitivity to alcohol | General disorders | Systematic Assessment |
|
| swollen feet | General disorders | Systematic Assessment |
|
| eye redness | Eye disorders | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |