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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000124 | U.S. NIH Grant/Contract | View source |
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Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the development of effective treatments for AUDs represents an important public health objective. Repositioning, i.e. using existing approved drugs for other indications, represents a fast and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting that it may be useful in the treatment of AUDs in humans. The goal of this project is to provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to treat AUDs.
Current pharmacotherapies for alcohol use disorders (AUDs) have limited efficacy. Thus, the development of effective treatments for AUDs represents an important public health objective. Repositioning, i.e. using existing approved drugs for other indications, represents a fast and economically feasible approach for drug development. Ivermectin (IVM) is an FDA-approved antiparasitic medication that can significantly reduce alcohol intake in mice, suggesting that it may be useful in the treatment of AUDs in humans. The goal of this project is to provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to treat AUDs. We will enroll 10 alcohol dependent individuals in a placebo-controlled randomized pilot safety trial of IVM (30 mg orally once) over a 2-day (1-night) inpatient stay at the UCLA CTRC and employ a well-characterized battery of behavioral paradigms (i.e., alcohol administration and cue exposure). The goals of the study are to test: (a) the safety of combining IVM, at a dose currently shown to be safe in humans (30 mg), with moderate doses of alcohol (0.08 g/dl); and (b) whether IVM reduces the reinforcing effects of alcohol during alcohol administration and whether it reduces alcohol craving during cue exposure, as compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin | Experimental | Ivermectin 30 mg single dose |
|
| Sugar pill | Placebo Comparator | Matched placebo, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate (measured in beats per minute; BPM) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). During the infusion, the times for collecting HR will vary based on how long it takes participants to reach the targeted BrACs. | Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl |
| Systolic Blood Pressure | Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs. | Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl |
| Diastolic Blood Pressure | Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs. | Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl |
| Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ) | Subjective effects of alcohol will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (1 = strongly disagree, 7 = strongly agree). |
| Measure | Description | Time Frame |
|---|---|---|
| Ivermectin Pharmacokinetics: Peak Concentration (Cmax) | This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Maximum plasma concentration (Cmax), measured in ng/mL, provided below. | Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lara Ray, PhD | University of California, Los Angeles | Principal Investigator |
| Daniel Roche, PhD | University of California, Los Angeles | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Addictions Laboratory | Los Angeles | California | 90095 | United States |
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| Label | URL |
|---|---|
| UCLA Addictions Laboratory | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | IVM 30mg First, Then Placebo | First Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Second Intervention, Placebo: Single dose sugar pill, matched to active medication. |
| FG001 | Placebo First, Then IVM 30 mg | First Intervention, Placebo: Single dose sugar pill, matched to active medication. Second Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
| |||||||||||||
| Second Intervention (1 Day) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IVM 30mg; Placebo | Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Placebo: Single dose sugar pill matched to active medication. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Heart Rate | Heart rate (measured in beats per minute; BPM) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). During the infusion, the times for collecting HR will vary based on how long it takes participants to reach the targeted BrACs. | All randomized subjects included. | Posted | Mean | Standard Deviation | BPM | Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl |
|
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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 | IVM 30mg | Ivermectin 30 mg single dose Ivermectin: Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin. Alcohol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lara Ray | UCLA Department of Psychology | 310-794-5383 | lararay@psych.ucla.edu |
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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 |
|---|---|
| D007559 | Ivermectin |
| D000073893 | Sugars |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Matched placebo |
|
|
| Alcohol | Drug |
|
|
| During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
| Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale | Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Do you feel any drug effects?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects). | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
| Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale | Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Do you like the effects you are feeling right now?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects). | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
| Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale | Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Would you like more of the drug right now?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects). | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
| Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale | Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Are you high?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects). | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
| Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale | Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Stimulant Subscale ranges from 0 to 70. Mean scores across all subjects are reported below. | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
| Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale | Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Sedative Subscale ranges from 0 to 70. Mean scores across subjects are reported below. | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
| Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ) | Cue-induced craving will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (0 = strongly disagree, 6 = strongly agree). Item scores were averaged and the total score also ranges from 0-6. | 6 hours post-medication administration |
| Adverse Effects | Adverse effects will be monitored to determine the safe of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl) using the Systematic Assessment for Treatment Emergent Effects (SAFTEE). The SAFTEE is a 24-item checklist in which the participant can identify whether a symptom is present (yes/no), its severity (mild, moderate, severe) and whether it was caused by the medication (yes/no). Data below represents a count of individual adverse effects reported on the SAFTEE during the alcohol infusion. | During alcohol infusion at BrAC = 0.00, 0.04, 0.08 g/dl |
| Ivermectin Pharmacokinetics: Time to Cmax (Tmax) | This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Time to Cmax (Tmax), measured in hours, provided below. | Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 |
| Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC) | This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Area under the time-concentration curve (AUC) from 0 to 48 hours after IVM administration, provided below. | Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 |
| Ivermectin Pharmacokinetics: Half-life (T1/2) | This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Half-life of ivermectin (T1/2), measured in hours, provided below. | Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 |
| Stress-induced Alcohol Craving | Alcohol Urge Questionnaire (AUQ) | pre-post exposure to an imaginal stress script |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Meets criteria for DSM-V AD | Number | participants |
|
|
|
|
| Primary | Systolic Blood Pressure | Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs. | All randomized subjects included. | Posted | Mean | Standard Deviation | mmHg | Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl |
|
|
|
|
| Primary | Diastolic Blood Pressure | Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs. | All randomized subjects included. | Posted | Mean | Standard Deviation | mmHg | Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl |
|
|
|
|
| Primary | Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ) | Subjective effects of alcohol will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (1 = strongly disagree, 7 = strongly agree). | All randomized subjects included. | Posted | Mean | Standard Deviation | scores on a scale | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
|
|
|
|
| Primary | Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale | Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Do you feel any drug effects?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects). | All randomized subjects included. | Posted | Mean | Standard Deviation | scores on a scale | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
|
|
|
|
| Primary | Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale | Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Do you like the effects you are feeling right now?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects). | All randomized subjects included. | Posted | Mean | Standard Deviation | scores on a scale | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
|
|
|
|
| Primary | Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale | Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Would you like more of the drug right now?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects). | All randomized subjects included. | Posted | Mean | Standard Deviation | scores on a scale | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
|
|
|
|
| Primary | Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale | Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Are you high?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects). | All randomized subjects included. | Posted | Mean | Standard Deviation | scores on a scale | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
|
|
|
|
| Primary | Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale | Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Stimulant Subscale ranges from 0 to 70. Mean scores across all subjects are reported below. | All randomized subjects included. | Posted | Mean | Standard Deviation | scores on a scale | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
|
|
|
|
| Primary | Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale | Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Sedative Subscale ranges from 0 to 70. Mean scores across subjects are reported below. | All randomized subjects included. | Posted | Mean | Standard Deviation | scores on a scale | During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours. |
|
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|
|
| Primary | Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ) | Cue-induced craving will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (0 = strongly disagree, 6 = strongly agree). Item scores were averaged and the total score also ranges from 0-6. | Posted | Mean | Standard Deviation | scores on a scale | 6 hours post-medication administration |
|
|
|
|
| Primary | Adverse Effects | Adverse effects will be monitored to determine the safe of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl) using the Systematic Assessment for Treatment Emergent Effects (SAFTEE). The SAFTEE is a 24-item checklist in which the participant can identify whether a symptom is present (yes/no), its severity (mild, moderate, severe) and whether it was caused by the medication (yes/no). Data below represents a count of individual adverse effects reported on the SAFTEE during the alcohol infusion. | All randomized subjects included. | Posted | Number | adverse effect count | During alcohol infusion at BrAC = 0.00, 0.04, 0.08 g/dl |
|
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| Secondary | Ivermectin Pharmacokinetics: Peak Concentration (Cmax) | This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Maximum plasma concentration (Cmax), measured in ng/mL, provided below. | All randomized subjects included. | Posted | Mean | Standard Deviation | ng/mL | Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 |
|
|
|
| Secondary | Ivermectin Pharmacokinetics: Time to Cmax (Tmax) | This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Time to Cmax (Tmax), measured in hours, provided below. | All randomized subjects included. | Posted | Mean | Standard Deviation | hours | Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 |
|
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| Secondary | Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC) | This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Area under the time-concentration curve (AUC) from 0 to 48 hours after IVM administration, provided below. | All randomized subjects included. | Posted | Mean | Standard Deviation | ng*h/mL | Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 |
|
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| Secondary | Ivermectin Pharmacokinetics: Half-life (T1/2) | This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Half-life of ivermectin (T1/2), measured in hours, provided below. | Posted | Mean | Standard Deviation | hours | Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 |
|
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| Secondary | Stress-induced Alcohol Craving | Alcohol Urge Questionnaire (AUQ) | The stress paradigm (pre-post exposure to an imaginal stress script) was not implemented from the outset of the study due to feasibility reasons. In particular, the investigators were concerned that the timing of the stress exposure might contaminate the effects of the alcohol administration. | Posted | pre-post exposure to an imaginal stress script |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | Matched placebo, single dose Placebo: sugar pill Alcohol | 0 | 11 | 0 | 11 |
Not provided
Not provided
| D002241 |
| Carbohydrates |
| D000438 | Alcohols |
| 1 hour post-med |
|
| 2 hours post-med |
|
| 4 hours post-med |
|
| 6 hours post-med |
|
| 8 hours post-med |
|
| 10 hours post-med |
|
| 12 hours post-med |
|
| 16 hours post-med |
|
| 24 hours post-med |
|
| 48 hours post-med |
|
| BrAC = 0 |
|
| BrAC = 0.02 |
|
| BrAC = 0.04 |
|
| BrAC = 0.06 |
|
| BrAC = 0.08 |
|
| 1 hour post-med |
|
| 2 hours post-med |
|
| 4 hours post-med |
|
| 6 hours post-med |
|
| 8 hours post-med |
|
| 10 hours post-med |
|
| 12 hours post-med |
|
| 16 hours post-med |
|
| 24 hours post-med |
|
| 48 hours post-med |
|
| BrAC = 0 |
|
| BrAC = 0.02 |
|
| BrAC = 0.04 |
|
| BrAC = 0.06 |
|
| BrAC = 0.08 |
|
| BrAC = 0.04 |
|
| BrAC = 0.06 |
|
| BrAC = 0.08 |
|
| BrAC = 0.04 |
|
| BrAC = 0.06 |
|
| BrAC = 0.08 |
|
| BrAC = 0.04 |
|
| BrAC = 0.06 |
|
| BrAC = 0.08 |
|
| BrAC = 0.04 |
|
| BrAC = 0.06 |
|
| BrAC = 0.08 |
|
| BrAC = 0.04 |
|
| BrAC = 0.06 |
|
| BrAC = 0.08 |
|
| BrAC = 0.04 |
|
| BrAC = 0.06 |
|
| BrAC = 0.08 |
|
| BrAC = 0.04 |
|
| BrAC = 0.06 |
|
| BrAC = 0.08 |
|
| Yellow eyes |
|
| Nausea or vomiting |
|
| Irritability or anger |
|
| Increased desire for sex |
|
| Nervousness |
|
| Ringing in the ears |
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| Decrease in appetite |
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| Depression |
|
| Fatigue |
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| Difficulty in staying awake |
|
| Increase in appetite |
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| Blurred vision |
|
| Drowsiness |
|
| Headache |
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| Night sweats |
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| Mental confusion |
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| Anxiety |
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| Joint or muscle pain |
|
| Dizziness |
|
| Sexual problems |
|
| Difficulty sleeping |
|
| Fever or chills |
|
| Decreased desire for sex |
|