Alcohol Drinking
Conditions
Brief summary
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.
Interventions
DRUGSaracatinib
Saracatinib 125 mg once per day for 8 days
DRUGPlacebos
Placebo once per day for 8 days
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 21-50 * Able to read English at 6th grade level or higher and to complete study evaluations * Regular alcohol drinker
Exclusion criteria
* Individuals who are seeking alcohol treatment * Medical conditions that would contraindicate the use of saracatinib * Regular use of other substances
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline) | Baseline and Day 8 | 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). |
| Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS | Baseline and Day 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES) | Day 8 Adlib | 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. |
| Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES) | Day 8 Adlib | 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. |
Countries
United States
Participant flow
Pre-assignment details
54 participants agreed to the study but 4 did not end up participating in the full study and were never randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| 125 mg Saracatinib Participants will take 125 mg of saracatinib daily for 8 days.
Saracatinib: Saracatinib 125 mg once per day for 8 days | 33 |
| Placebo Participants will take placebo daily for 8 days.
Placebos: Placebo once per day for 8 days | 17 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 2 |
Baseline characteristics
| Characteristic | 125 mg Saracatinib | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 7.8 | 29 years STANDARD_DEVIATION 7.8 | 30 years STANDARD_DEVIATION 7.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 17 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 31 Participants | 10 Participants |
| Region of Enrollment United States | 33 Participants | 50 Participants | 17 Participants |
| Sex: Female, Male Female | 17 Participants | 25 Participants | 8 Participants |
| Sex: Female, Male Male | 16 Participants | 25 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 17 |
| other Total, other adverse events | 21 / 33 | 8 / 17 |
| serious Total, serious adverse events | 1 / 33 | 1 / 17 |
Outcome results
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).
Time frame: Baseline and Day 8
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 125 mg Saracatinib | Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline) | -1.85 drinks | Standard Error 0.75 |
| Placebo | Change in the Number of Drinks Consumed From Baseline to Day 8 (Minus Baseline) | -2.33 drinks | Standard Error 0.99 |
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.
Time frame: Baseline and Day 7
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 125 mg Saracatinib | Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS | 3133 units on a scale*days | Standard Error 371 |
| Placebo | Craving-Baseline Adjusted Total Area Under the Curve (AUC) During the Drinking Session Using the YCS | 2876 units on a scale*days | Standard Error 489 |
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.
Time frame: Day 8 Adlib
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 125 mg Saracatinib | Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES) | 1149.9 units on a scale*days | Standard Deviation 1495.5 |
| Placebo | Area Under the Curve (AUC) During the Drinking Session Using the Sedation Responses to Alcohol (BAES) | 515.29 units on a scale*days | Standard Deviation 551 |
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.
Time frame: Day 8 Adlib
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 125 mg Saracatinib | Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES) | 1650.8 units on a scale*days | Standard Deviation 2185.7 |
| Placebo | Area Under the Curve (AUC) During the Drinking Session Using the Stimulation Responses to Alcohol (BAES) | 1607.1 units on a scale*days | Standard Deviation 1984.3 |