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| ID | Type | Description | Link |
|---|---|---|---|
| P50AA012870 | 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 alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol related responses. This is a within subjects open label study in which the investigators plan to run 8 subjects to obtain 5 completers.
The purpose of this alcohol-interaction pilot study is to provide information on the effect of AZD0530 (Saracatinib) on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of a single dose of AZD0530 (125 mg) on alcohol related responses. This is a within subjects open label study in which the investigators plan to run 8 subjects to obtain 5 completers.
Subjects will participate in two lab sessions, one prior to taking medication and one following 8-11 days of AZD0530. During each session, participants will receive successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl; this dose was chosen because this is close to the legal limit of intoxication and to the peak blood alcohol content (BAC) we have observed in prior research studies.Subjects will be monitored throughout the lab session and will receive a phone call two days following the 2nd lab session and a follow-up appointment one week after the 2nd lab session to assess any remaining side effects from the medication.
Once it is determined that there is no change in the pharmacokinetics of alcohol or AZD0530, as well as no difference in behavioral or cognitive responses to alcohol in the presence of AZD0530, the investigators will begin the pilot study examining the effects of two doses of AZD0530 on behavioral measures related to alcohol self-administration following a fixed dose of alcohol in alcohol abusive or dependent heavy drinkers, and compare responses to those obtained from historical controls who were treated with placebo in Study 1. Subjects will be randomized to one of two doses of AZD0530 (50 mg/day or 125 mg/day) as a between subjects factor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 125 mg Saracatinib | Experimental | 125 mg Saracatinib once daily for 8-11 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saracatinib | Drug | Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety/Tolerability of Study Medication. | Number of subjects - taking 125 mg of AZD0530 (saracatinib) over 8 days - in an alcohol drinking paradigm raising blood alcohol to 80 mg/dl who had any concerning changes in physiological or behavioral outcome measures. | 8 days |
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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 |
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Subjects were recruited online via craigslist.com and through local flyering
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| ID | Title | Description |
|---|---|---|
| FG000 | 125 mg Saracatinib | . Subjects participated in two inpatient alcohol administration lab sessions, a baseline session and a second session after taking 125 mg of AZD0530 for 8 outpatient days. During the outpatient drug administration phase subjects came in daily to receive their medication and at that time adverse events were assessed. Subject administration of daily medication dose was observed. The baseline session allowed participants to familiarize themselves with the procedures and provide us with a medication-free comparison for the effects of AZD0530 within the same subjects. During each lab session, subjects received six successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 125 mg Saracatinib | 125 mg Saracatinib once daily for 8-11 days Saracatinib: Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session |
| 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 | Safety/Tolerability of Study Medication. | Number of subjects - taking 125 mg of AZD0530 (saracatinib) over 8 days - in an alcohol drinking paradigm raising blood alcohol to 80 mg/dl who had any concerning changes in physiological or behavioral outcome measures. | Posted | Number | participants | 8 days |
|
5 months
AE's were collected using the SAFTEE: Levine J., & Schooler N.R. (1986). SAFTEE: a technique for the systematic assessment of side effects in clinical trials. Psychopharmacology Bulletin, 22(2):343-81.
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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 | Subjects participated in two inpatient alcohol administration lab sessions, a baseline session and a second session after taking 125 mg of AZD0530 for 8 outpatient days. During the outpatient drug administration phase subjects came in daily to receive their medication and at that time adverse events were assessed. Subject administration of daily medication dose was observed. The baseline session allowed participants to familiarize themselves with the procedures and provide us with a medication-free comparison for the effects of AZD0530 within the same subjects. During each lab session, subjects received six successive doses of alcohol over a 90 min period designed to raise their blood alcohol levels to 80 mg/dl. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sleepy | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Suchitra Krishnan-Sarin | Yale University Dept of Psychiatry | 203-974-7595 | suchitra.krishnan-sarin@yale.edu |
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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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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| Decrease in appetite | Gastrointestinal disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| eye twitch (right) | Eye disorders | Systematic Assessment |
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