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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50AA012870-16 | 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 evaluate the effects of the study medication, saracatinib/AZD0530 (placebo or 125 mg/day) on alcohol drinking behavior in a laboratory setting in which participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. The investigators hypothesize that saracatinib will reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 125 mg saracatinib | Experimental | Participants will take 125 mg of saracatinib daily for 8 days. |
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| Placebo | Placebo Comparator | Participants will take placebo daily for 8 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saracatinib | Drug | Saracatinib 125 mg once per day for 8 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline) | Change in the number of standard drinks consumed at the drinking session (ADP 2) after taking study medication minus the number of standard drinks consumed at baseline (ADP 1). | Baseline and Day 8 |
| Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS | Craving for alcohol based on Yale Craving Scale (YCS), scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7. | Baseline and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES) | Biphasic Alcohol Effects Scale (BAES) scores will be used to assess stimulation. The scale ranges from 0-70, with a higher score indicating more sedated. | Day 8 Adlib |
| Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMHC, Substance Abuse Center | New Haven | Connecticut | 06519 | United States |
54 participants agreed to the study but 4 did not end up participating in the full study and were never randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 125 mg Saracatinib | Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days |
| FG001 | Placebo | Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 125 mg Saracatinib | Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days |
| BG001 | Placebo | Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days |
| Units | Counts |
|---|---|
| Participants |
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| 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 in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline) | Change in the number of standard drinks consumed at the drinking session (ADP 2) after taking study medication minus the number of standard drinks consumed at baseline (ADP 1). | Posted | Least Squares Mean | Standard Error | drinks | Baseline and Day 8 |
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Adverse Event data were collected at baseline, daily during the 8 days of medication and then at one month follow-up.
Adverse events were collected multiple times throughout the study: at baseline, daily during medication dosing, and one month following completion of study.
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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 | 125 mg Saracatinib | Participants will take 125 mg of saracatinib daily for 8 days. Saracatinib: Saracatinib 125 mg once per day for 8 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| car accident | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Cavallo, Project Coordinator | Yale School of Medicine | 203-610-9788 | dana.cavallo@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2019 | Apr 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C515233 | saracatinib |
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| Placebos | Drug | Placebo once per day for 8 days |
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Biphasic Alcohol Effects Scale (BAES) scores will be used to assess sedation. The scale ranges from 0-70, with a higher score indicating more sedated. |
| Day 8 Adlib |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS | Craving for alcohol based on Yale Craving Scale (YCS), scores ranging from 0-112 mm on a visual analog scale, with higher measurements indicating higher craving. The baseline-adjusted craving is change score from baseline at Day 7. | Posted | Least Squares Mean | Standard Error | units on a scale*days | Baseline and Day 7 |
|
|
|
| Secondary | Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES) | Biphasic Alcohol Effects Scale (BAES) scores will be used to assess stimulation. The scale ranges from 0-70, with a higher score indicating more sedated. | Posted | Mean | Standard Deviation | units on a scale*days | Day 8 Adlib |
|
|
|
| Secondary | Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES) | Biphasic Alcohol Effects Scale (BAES) scores will be used to assess sedation. The scale ranges from 0-70, with a higher score indicating more sedated. | Posted | Mean | Standard Deviation | units on a scale*days | Day 8 Adlib |
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| 0 |
| 33 |
| 1 |
| 33 |
| 21 |
| 33 |
| EG001 | Placebo | Participants will take placebo daily for 8 days. Placebos: Placebo once per day for 8 days | 0 | 17 | 1 | 17 | 8 | 17 |
| hernia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Fatigue | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Cold symptoms | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Joint Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Sore throat | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| High feeling | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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