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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA026255 | 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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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects received oral placebo capsules one time daily. |
|
| Duloxetine (60 MG) | Experimental | Subjects received 60 mg of oral duloxetine one time daily. |
|
| Duloxetine (30 MG) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol | Drug | In each arm and during sessions, subjects will receive doses of alcohol designed to raise breath alcohol levels (BAL) to 0.03 g/dl. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
| 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. | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Craig Rush, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40511 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. Methylphenidate: Subjects will receive methylphenidate capsules. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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. | Posted | Mean | 95% Confidence Interval | Units on a Theoretical Scale | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
|
Four weeks
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.
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig R. Rush, Ph.D. | University of Kentucky | 8592575388 | crush2@uky.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 | May 31, 2018 | Feb 26, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2023 | Feb 26, 2024 | ICF_002.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 |
|---|---|
| D000431 | Ethanol |
| D000068736 | Duloxetine Hydrochloride |
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Placebos | Drug | Subjects will receive oral placebo capsules. |
|
| Duloxetine (60 MG) | Drug | Subjects will receive 60-mg of oral duloxetine capsules. |
|
| Methylphenidate | Drug | Subjects will receive methylphenidate capsules. |
|
| Duloxetine (30 MG) | Drug | Subjects will receive 30-mg of oral duloxetine capsules. |
|
| Measured at each methylphenidate dose-level over approximately four weeks of participation. |
| 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 | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
| 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 | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
| 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 | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
| 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. | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
| 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. | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
| 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. | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
| 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. | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
| 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. Methylphenidate: Subjects will receive methylphenidate capsules. |
| OG002 | 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. |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Units on a Theoretical Scale | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | g/dl | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Millimeters of mercury | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Millimeter of mercury | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Beats per minute | Measured at each methylphenidate dose-level over approximately four weeks of participation. |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 11 |
| 11 |
| EG001 | 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. Methylphenidate: Subjects will receive methylphenidate capsules. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | Duloxetine (60 MG) | Subjects received 60 mg 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. | 0 | 6 | 0 | 6 | 6 | 6 |
| Anxiety | Nervous system disorders | Systematic Assessment |
|
| Body Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | General disorders | Systematic Assessment |
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| Ear Congestion | Ear and labyrinth disorders | Systematic Assessment |
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| Change in Urination | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Weakness | General disorders | Systematic Assessment |
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| Loss of Voice | General disorders | Systematic Assessment |
|
| Muscle Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Nervousness | Nervous system disorders | Systematic Assessment |
|
| Changes in Sexual Function | Reproductive system and breast disorders | Systematic Assessment |
|
| Sleepiness/Dowsiness | General disorders | Systematic Assessment |
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| Sore Throat | General disorders | Systematic Assessment |
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| Stuffy/Runny nose | General disorders | Systematic Assessment |
|
| Sweating | General disorders | Systematic Assessment |
|
| Weight Change | General disorders | Systematic Assessment |
|
| Unusual Bruising/Bleeding | General disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
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| Restlessness | General disorders | Systematic Assessment |
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| Irritability | General disorders | Systematic Assessment |
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| Decreased Appetite | General disorders | Systematic Assessment |
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| Increased Appetite | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Racing/Pounding Heart | Cardiac disorders | Systematic Assessment |
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| Itchness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| Methylphenidate (20 mg) |
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| Methylphenidate (40 mg) |
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| Methylphenidate (60 mg) |
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| Like Drink |
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| Want Drink |
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| Like Drink |
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| Want Drink |
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| Like Drink |
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| Want Drink |
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| Like Drink |
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| Want Drink |
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| Methylphenidate (40 mg) |
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| Methylphenidate (60 mg) |
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| Methylphenidate (40 mg) |
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| Methylphenidate (60 mg) |
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| Methylphenidate (40 mg) |
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| Methylphenidate (60 mg) |
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| Methylphenidate (40 mg) |
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| Methylphenidate (60 mg) |
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