Alcohol Use Disorder
Conditions
Brief summary
This study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.
Detailed description
Prior to the outbreak of the COVID-19 virus and subsequent work-from-home orders from the state of Kentucky government, participants completed five overnight sessions at theUniversity of Kentucky Inpatient Research Unit in the medical center. The protocol was then changed to have five sessions scheduled to be completed on an outpatient basis in the late afternoon/early evening. This protocol change was enacted following the resumption of research in the fall of 2020. For both the inpatient and outpatient portions of this protocol, the first of these sessions was a practice session to familiarize participants with experimental procedures. The subsequent four experimental sessions were conducted following one-week maintenance on a methylphenidate dose (0, 20, 40, and 60 mg/day; within-subjects factor) over the span of four weeks. Participants were assigned to either an active duloxetine arm (60 mg/day) or placebo arm (between-subjects factor) also for the span of four weeks. The outcome measures collected were the same for both the inpatient and outpatient aspects of the study. Subjects received 30 mg of oral duloxetine one time daily. Note: only 2 subjects were enrolled in this arm prior to the arm being removed in the summer of 2020. Data from this arm will not be reported in order to avoid any HIPAA violation due to the small number of subjects in this arm. Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, visual inspection of their data revealed that their data was not appreciably different from participants in the 60 mg/day duloxetine arm. Therefore, we have added the data from these two participants to the 60 mg/day duloxetine arm for all reported data.
Interventions
DRUGAlcohol
In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
DRUGPlacebos
Subjects will receive oral placebo capsules.
Subjects will receive 60-mg of oral duloxetine capsules.
DRUGMethylphenidate
Subjects will receive methylphenidate capsules.
DRUGDuloxetine (30 MG)
Subjects will receive 30-mg of oral duloxetine capsules.
Sponsors
Craig Rush
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* able to speak/read English * not seeking treatment at the time of the study * one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days * recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder * ECG within normal limits * otherwise healthy * body mass index of 19-35 * females using an effective form of birth control and not pregnant or breast feeding * judged by the medical staff to be psychiatrically and physically healthy * able to abstain from alcohol for 12 hours prior to session
Exclusion criteria
* Not under 21 years of age or over 55 years of age * no contraindications/allergies to alcohol, duloxetine, or methylphenidate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reinforcing Effects (Pre-Alcohol Dose Consumption) | Measured at each methylphenidate dose-level over approximately four weeks of participation. | The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value. |
| Reinforcing Effects (Post-Alcohol Dose Consumption) | Measured at each methylphenidate dose-level over approximately four weeks of participation. | The reinforcing effects of alcohol will be determined using a alcohol purchase procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent "alpha", which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected following consumption of the alcohol dose. There is no minimum or maximum value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Measured at each methylphenidate dose-level over approximately four weeks of participation. | Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol |
| Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Measured at each methylphenidate dose-level over approximately four weeks of participation. | Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol |
| Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Measured at each methylphenidate dose-level over approximately four weeks of participation. | Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol |
| Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Measured at each methylphenidate dose-level over approximately four weeks of participation. | Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol |
| Breath Alcohol Level | Measured at each methylphenidate dose-level over approximately four weeks of participation. | Expired air samples for determining breath alcohol level (BAL) will be recorded during four experimental sessions. BALs were recorded as g/dl. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. Greater values of BAL represent more alcohol absorbed following consumption. |
| Systolic Blood Pressure | Measured at each methylphenidate dose-level over approximately four weeks of participation. | Systolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. |
| Diastolic Blood Pressure | Measured at each methylphenidate dose-level over approximately four weeks of participation. | Diastolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. |
| Heart Rate | Measured at each methylphenidate dose-level over approximately four weeks of participation. | Heart rate (beats per minute) will be recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCraig Rush, PhD
University of Kentucky
Participant flow
Pre-assignment details
Please note that at the initial execution of the study, there were three duloxetine arms: 0, 30, and 60 mg/day. Two participants received 30 mg/day. However, to avoid the risk of HIPAA violation, data from these two participants will not be reported.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Subjects received oral placebo capsules one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Placebos: Subjects will receive placebo capsules.
Methylphenidate: Subjects will receive methylphenidate capsules. | 11 |
| Duloxetine (30 MG) Subjects received 30 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules. | 2 |
| Duloxetine (60 MG) Subjects received 60 mg of oral duloxetine one time daily.
Alcohol: In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl.
Duloxetine: Subjects will receive duloxetine capsules.
Methylphenidate: Subjects will receive methylphenidate capsules. | 6 |
| Total | 19 |
Baseline characteristics
| Characteristic | Duloxetine (30 MG) | Duloxetine (60 MG) | Total | Placebo |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 6 Participants | 19 Participants | 11 Participants |
| Age, Continuous | 32.50 years STANDARD_DEVIATION 13.44 | 30.25 years STANDARD_DEVIATION 10.66 | 30.48 years STANDARD_DEVIATION 9.46 | 31.27 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 6 Participants | 17 Participants | 9 Participants |
| Region of Enrollment United States | 2 participants | 6 participants | 19 participants | 11 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 2 | 0 / 6 |
| other Total, other adverse events | 11 / 11 | 2 / 2 | 6 / 6 |
| serious Total, serious adverse events | 0 / 11 | 0 / 2 | 0 / 6 |
Outcome results
Primary
Reinforcing Effects (Post-Alcohol Dose Consumption)
The reinforcing effects of alcohol will be determined using a alcohol purchase procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent alpha, which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected following consumption of the alcohol dose. There is no minimum or maximum value.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (0 mg) | 0.004 Units on a Theoretical Scale |
| Placebo | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (20 mg) | 0.005 Units on a Theoretical Scale |
| Placebo | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (40 mg) | 0.005 Units on a Theoretical Scale |
| Placebo | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (60 mg) | 0.005 Units on a Theoretical Scale |
| Duloxetine 30 mg | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (60 mg) | .01 Units on a Theoretical Scale |
| Duloxetine 30 mg | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (0 mg) | .01 Units on a Theoretical Scale |
| Duloxetine 30 mg | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (40 mg) | .014 Units on a Theoretical Scale |
| Duloxetine 30 mg | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (20 mg) | .01 Units on a Theoretical Scale |
| Duloxetine (60 MG) | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (60 mg) | 0.009 Units on a Theoretical Scale |
| Duloxetine (60 MG) | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (20 mg) | 0.007 Units on a Theoretical Scale |
| Duloxetine (60 MG) | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (40 mg) | 0.006 Units on a Theoretical Scale |
| Duloxetine (60 MG) | Reinforcing Effects (Post-Alcohol Dose Consumption) | Methylphenidate (0 mg) | 0.006 Units on a Theoretical Scale |
Primary
Reinforcing Effects (Pre-Alcohol Dose Consumption)
The reinforcing effects of alcohol will be determined using a alcohol purchase task procedure in which subjects will report the number of alcohol drinks they would purchase across changes in price. The questions that were asked were completely hypothetical. The reinforcing effects are measured during experimental session maintenance on methylphenidate and placebo or duloxetine. These data represent alpha, which a rate measure of sensitivity to changes in price: greater values represent great sensitivity to price changes. These data were collected prior to consumption of the alcohol dose. There is no minimum or maximum value.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (40 mg) | 0.005 Units on a Theoretical Scale |
| Placebo | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (0 mg) | 0.005 Units on a Theoretical Scale |
| Placebo | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (20 mg) | 0.005 Units on a Theoretical Scale |
| Placebo | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (60 mg) | 0.005 Units on a Theoretical Scale |
| Duloxetine 30 mg | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (60 mg) | .02 Units on a Theoretical Scale |
| Duloxetine 30 mg | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (40 mg) | 0.014 Units on a Theoretical Scale |
| Duloxetine 30 mg | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (20 mg) | .02 Units on a Theoretical Scale |
| Duloxetine 30 mg | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (0 mg) | .01 Units on a Theoretical Scale |
| Duloxetine (60 MG) | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (60 mg) | 0.008 Units on a Theoretical Scale |
| Duloxetine (60 MG) | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (0 mg) | 0.007 Units on a Theoretical Scale |
| Duloxetine (60 MG) | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (20 mg) | 0.007 Units on a Theoretical Scale |
| Duloxetine (60 MG) | Reinforcing Effects (Pre-Alcohol Dose Consumption) | Methylphenidate (40 mg) | 0.007 Units on a Theoretical Scale |
Secondary
Breath Alcohol Level
Expired air samples for determining breath alcohol level (BAL) will be recorded during four experimental sessions. BALs were recorded as g/dl. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol. Greater values of BAL represent more alcohol absorbed following consumption.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Breath Alcohol Level | Methylphenidate (60 mg) | 0.026 g/dl | Standard Deviation 0.007 |
| Placebo | Breath Alcohol Level | Methylphenidate (20 mg) | 0.024 g/dl | Standard Deviation 0.006 |
| Placebo | Breath Alcohol Level | Methylphenidate (40 mg) | 0.024 g/dl | Standard Deviation 0.008 |
| Placebo | Breath Alcohol Level | Methylphenidate (0 mg) | 0.026 g/dl | Standard Deviation 0.014 |
| Duloxetine 30 mg | Breath Alcohol Level | Methylphenidate (40 mg) | 0.041 g/dl | Standard Deviation 0.006 |
| Duloxetine 30 mg | Breath Alcohol Level | Methylphenidate (60 mg) | 0.023 g/dl | Standard Deviation 0.005 |
| Duloxetine 30 mg | Breath Alcohol Level | Methylphenidate (20 mg) | 0.031 g/dl | Standard Deviation 0.004 |
| Duloxetine 30 mg | Breath Alcohol Level | Methylphenidate (0 mg) | 0.031 g/dl | Standard Deviation 0.006 |
| Duloxetine (60 MG) | Breath Alcohol Level | Methylphenidate (60 mg) | 0.037 g/dl | Standard Deviation 0.015 |
| Duloxetine (60 MG) | Breath Alcohol Level | Methylphenidate (20 mg) | 0.042 g/dl | Standard Deviation 0.03 |
| Duloxetine (60 MG) | Breath Alcohol Level | Methylphenidate (40 mg) | 0.034 g/dl | Standard Deviation 0.021 |
| Duloxetine (60 MG) | Breath Alcohol Level | Methylphenidate (0 mg) | 0.029 g/dl | Standard Deviation 0.013 |
Secondary
Diastolic Blood Pressure
Diastolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Diastolic Blood Pressure | Methylphenidate (60 mg) | 74.00 Millimeter of mercury | Standard Deviation 8.89 |
| Placebo | Diastolic Blood Pressure | Methylphenidate (40 mg) | 74.22 Millimeter of mercury | Standard Deviation 7.08 |
| Placebo | Diastolic Blood Pressure | Methylphenidate (0 mg) | 73.56 Millimeter of mercury | Standard Deviation 10.17 |
| Placebo | Diastolic Blood Pressure | Methylphenidate (20 mg) | 74.00 Millimeter of mercury | Standard Deviation 9.49 |
| Duloxetine 30 mg | Diastolic Blood Pressure | Methylphenidate (20 mg) | 88.50 Millimeter of mercury | Standard Deviation 6.36 |
| Duloxetine 30 mg | Diastolic Blood Pressure | Methylphenidate (60 mg) | 82.00 Millimeter of mercury | Standard Deviation 8.49 |
| Duloxetine 30 mg | Diastolic Blood Pressure | Methylphenidate (40 mg) | 85.50 Millimeter of mercury | Standard Deviation 9.19 |
| Duloxetine 30 mg | Diastolic Blood Pressure | Methylphenidate (0 mg) | 82.00 Millimeter of mercury | Standard Deviation 12.73 |
| Duloxetine (60 MG) | Diastolic Blood Pressure | Methylphenidate (40 mg) | 80.33 Millimeter of mercury | Standard Deviation 5.09 |
| Duloxetine (60 MG) | Diastolic Blood Pressure | Methylphenidate (20 mg) | 77.00 Millimeter of mercury | Standard Deviation 8.51 |
| Duloxetine (60 MG) | Diastolic Blood Pressure | Methylphenidate (0 mg) | 77.67 Millimeter of mercury | Standard Deviation 6.71 |
| Duloxetine (60 MG) | Diastolic Blood Pressure | Methylphenidate (60 mg) | 80.50 Millimeter of mercury | Standard Deviation 9.14 |
Secondary
Heart Rate
Heart rate (beats per minute) will be recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Heart Rate | Methylphenidate (0 mg) | 75.89 Beats per minute | Standard Deviation 11.47 |
| Placebo | Heart Rate | Methylphenidate (20 mg) | 83.44 Beats per minute | Standard Deviation 12.63 |
| Placebo | Heart Rate | Methylphenidate (40 mg) | 81.67 Beats per minute | Standard Deviation 7.48 |
| Placebo | Heart Rate | Methylphenidate (60 mg) | 83.89 Beats per minute | Standard Deviation 13.04 |
| Duloxetine 30 mg | Heart Rate | Methylphenidate (60 mg) | 80.50 Beats per minute | Standard Deviation 2.12 |
| Duloxetine 30 mg | Heart Rate | Methylphenidate (0 mg) | 66.50 Beats per minute | Standard Deviation 4.95 |
| Duloxetine 30 mg | Heart Rate | Methylphenidate (40 mg) | 73.50 Beats per minute | Standard Deviation 2.12 |
| Duloxetine 30 mg | Heart Rate | Methylphenidate (20 mg) | 80.50 Beats per minute | Standard Deviation 3.54 |
| Duloxetine (60 MG) | Heart Rate | Methylphenidate (60 mg) | 98.50 Beats per minute | Standard Deviation 21.72 |
| Duloxetine (60 MG) | Heart Rate | Methylphenidate (20 mg) | 84.83 Beats per minute | Standard Deviation 11.43 |
| Duloxetine (60 MG) | Heart Rate | Methylphenidate (40 mg) | 88.83 Beats per minute | Standard Deviation 13.01 |
| Duloxetine (60 MG) | Heart Rate | Methylphenidate (0 mg) | 75.83 Beats per minute | Standard Deviation 11.41 |
Secondary
Systolic Blood Pressure
Systolic blood pressure (millimeter of mercury) was recorded during four experimental sessions. Data are presented as mean peak effect. Peak effect means the highest rated value following administration of oral alcohol.
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Systolic Blood Pressure | Methylphenidate (60 mg) | 125.44 Millimeters of mercury | Standard Deviation 12.17 |
| Placebo | Systolic Blood Pressure | Methylphenidate (40 mg) | 123.33 Millimeters of mercury | Standard Deviation 10.39 |
| Placebo | Systolic Blood Pressure | Methylphenidate (0 mg) | 125.00 Millimeters of mercury | Standard Deviation 13.65 |
| Placebo | Systolic Blood Pressure | Methylphenidate (20 mg) | 126.67 Millimeters of mercury | Standard Deviation 12.35 |
| Duloxetine 30 mg | Systolic Blood Pressure | Methylphenidate (0 mg) | 129.00 Millimeters of mercury | Standard Deviation 19.8 |
| Duloxetine 30 mg | Systolic Blood Pressure | Methylphenidate (20 mg) | 140.00 Millimeters of mercury | Standard Deviation 9.9 |
| Duloxetine 30 mg | Systolic Blood Pressure | Methylphenidate (40 mg) | 130.00 Millimeters of mercury | Standard Deviation 18.38 |
| Duloxetine 30 mg | Systolic Blood Pressure | Methylphenidate (60 mg) | 131.50 Millimeters of mercury | Standard Deviation 9.19 |
| Duloxetine (60 MG) | Systolic Blood Pressure | Methylphenidate (40 mg) | 124.33 Millimeters of mercury | Standard Deviation 8.73 |
| Duloxetine (60 MG) | Systolic Blood Pressure | Methylphenidate (0 mg) | 124.00 Millimeters of mercury | Standard Deviation 8.9 |
| Duloxetine (60 MG) | Systolic Blood Pressure | Methylphenidate (20 mg) | 121.67 Millimeters of mercury | Standard Deviation 6.53 |
| Duloxetine (60 MG) | Systolic Blood Pressure | Methylphenidate (60 mg) | 127.50 Millimeters of mercury | Standard Deviation 11.98 |
Secondary
Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Like Drink | 12.33 units on a scale | Standard Deviation 16.08 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Feel Drink | 15.89 units on a scale | Standard Deviation 15.45 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Want Drink | 17.22 units on a scale | Standard Deviation 17.48 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Feel High | 0.11 units on a scale | Standard Deviation 0.33 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Want Drink | 7.50 units on a scale | Standard Deviation 0.71 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Like Drink | 4.50 units on a scale | Standard Deviation 0.71 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Feel High | 1.00 units on a scale | Standard Deviation 1.41 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Feel Drink | 4.50 units on a scale | Standard Deviation 2.12 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Like Drink | 25.33 units on a scale | Standard Deviation 20.3 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Feel High | 2.00 units on a scale | Standard Deviation 3.95 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Want Drink | 23.50 units on a scale | Standard Deviation 20.42 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (0 mg) Maintenance. | Feel Drink | 22.00 units on a scale | Standard Deviation 17.34 |
Secondary
Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Feel Drink | 17.44 units on a scale | Standard Deviation 11.68 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Feel High | 0.22 units on a scale | Standard Deviation 0.67 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Want Drink | 19.22 units on a scale | Standard Deviation 19.57 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Like Drink | 16.78 units on a scale | Standard Deviation 23.55 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Want Drink | 15.50 units on a scale | Standard Deviation 4.95 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Feel Drink | 10.50 units on a scale | Standard Deviation 6.36 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Feel High | 1.50 units on a scale | Standard Deviation 2.12 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Like Drink | 9.50 units on a scale | Standard Deviation 6.36 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Want Drink | 32.33 units on a scale | Standard Deviation 24.66 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Like Drink | 27.33 units on a scale | Standard Deviation 22.14 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Feel High | 1.83 units on a scale | Standard Deviation 4.02 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (20 mg) Maintenance. | Feel Drink | 28.50 units on a scale | Standard Deviation 20.11 |
Secondary
Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Want Drink | 11.11 units on a scale | Standard Deviation 12.58 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Feel High | 0.11 units on a scale | Standard Deviation 0.33 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Feel Drink | 10.67 units on a scale | Standard Deviation 8.79 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Like Drink | 16.89 units on a scale | Standard Deviation 21.97 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Want Drink | 15.00 units on a scale | Standard Deviation 0 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Feel Drink | 7.50 units on a scale | Standard Deviation 2.12 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Like Drink | 10.00 units on a scale | Standard Deviation 1.41 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Feel High | 1.00 units on a scale | Standard Deviation 1.41 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Want Drink | 26.00 units on a scale | Standard Deviation 27.31 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Feel Drink | 20.17 units on a scale | Standard Deviation 11.5 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Like Drink | 24.00 units on a scale | Standard Deviation 18.28 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (40 mg) Maintenance. | Feel High | 2.50 units on a scale | Standard Deviation 4.18 |
Secondary
Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance.
Subjects will complete measures using visual analog scales rated from 0-100 mm to report alcohol effects during four experimental sessions. These items will ask about alcohol effects. Higher scores indicate greater effects. Data are presented as mean peak effect. Peak effect means the highest rated value (0 - 100 mm) following administration of oral alcohol
Time frame: Measured at each methylphenidate dose-level over approximately four weeks of participation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Like Drink | 10.78 units on a scale | Standard Deviation 12.77 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Want Drink | 8.44 units on a scale | Standard Deviation 13.6 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Feel High | 0.11 units on a scale | Standard Deviation 0.33 |
| Placebo | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Feel Drink | 12.67 units on a scale | Standard Deviation 10.97 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Feel Drink | 5.50 units on a scale | Standard Deviation 2.12 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Feel High | 1.00 units on a scale | Standard Deviation 1.41 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Want Drink | 15.00 units on a scale | Standard Deviation 1.41 |
| Duloxetine 30 mg | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Like Drink | 8.00 units on a scale | Standard Deviation 0 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Want Drink | 15.17 units on a scale | Standard Deviation 11.48 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Feel Drink | 17.17 units on a scale | Standard Deviation 13.83 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Feel High | 1.17 units on a scale | Standard Deviation 2.4 |
| Duloxetine (60 MG) | Visual Analog Scales of Alcohol Effects Following Methylphenidate (60 mg) Maintenance. | Like Drink | 20.50 units on a scale | Standard Deviation 21.14 |