Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in anxiety, as measured by blood pressure (systolic and diastolic), by treatment group during stress reactivity conditions. |
Anxiety is measured via blood pressure (systolic and diastolic). Participants will undergo stress (PTSD) reactivity conditions (both neutral and trauma) on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in blood pressure is computed as the difference in measurements taken across the PTSD Reactivity Conditions to the measurement collected immediately prior to the stress condition. |
On each Test Day (1-3), from baseline (prior to stress condition) to the end of the PTSD stress reactivity conditions |
|
| Primary |
Change in anxiety, as measured by heart rate, by treatment group during stress reactivity conditions. |
Anxiety is measured via heart rate. Participants will undergo stress (PTSD) reactivity conditions (both neutral and trauma) on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in heart rate is computed as the difference in measurements taken across the PTSD Reactivity Conditions to the measurement collected immediately prior to the stress condition. |
On each Test Day (1-3), from baseline (prior to stress condition) to the end of the PTSD stress reactivity conditions . |
|
| Primary |
Change in anxiety, as measured by the State Trait Anxiety Inventory (STAI-6), by treatment group during stress reactivity conditions. |
Anxiety is measured via the State Trait Anxiety Inventory (STAI-6). Participants will undergo stress (PTSD) reactivity conditions (both neutral and trauma) on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in STAI-6 score is computed as the difference in measurements taken across the PTSD Reactivity Conditions to the measurement collected immediately prior to the stress condition. |
On each Test Day (1-3), from baseline (prior to stress condition) to the end of the PTSD stress reactivity conditions. |
|
| Primary |
Change in alcohol craving, as measured by the Yale Craving Scale (YCS), by treatment group during stress reactivity conditions. |
Alcohol craving is measured via the Yale Craving Scale (score range is 0 to 112, with 0 meaning "no sensation" and 112 meaning "strongest imaginable sensation of any kind"). Participants will undergo stress (PTSD) reactivity conditions (both neutral and trauma) on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in YCS is computed as the difference in measurements taken across the PTSD Reactivity Conditions to the measurement collected immediately prior to the stress condition. |
On each Test Day (1-3), from baseline (prior to stress condition) to the end of the PTSD stress reactivity conditions. |
|
| Primary |
Change in mood disturbance, as measured by Drugs Effects Questionnaire (DEQ), by treatment group during stress reactivity conditions. |
Mood disturbance is measured via the Drugs Effects Questionnaire (DEQ). Participants will undergo stress (PTSD) reactivity conditions (both neutral and trauma) on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in DEQ is computed as the difference in measurements taken across the PTSD Reactivity Conditions to the measurement collected immediately prior to the stress condition. |
On each Test Day (1-3), from baseline (prior to stress condition) to the end of the PTSD stress reactivity conditions. |
|
| Primary |
Change in mood disturbance, as measured by Visual Analog Scale (VAS), by treatment group during stress reactivity conditions. |
Mood disturbance is measured via the Visual Analog Scale (score range is 0 to 100, with 0 having no specific mood disturbance and 100 having extreme specific mood disturbance). Participants will undergo stress (PTSD) reactivity conditions (both neutral and trauma) on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in VAS is computed as the difference in measurements taken across the PTSD Reactivity Conditions to the measurement collected immediately prior to the stress condition. |
On each Test Day (1-3), from baseline (prior to stress condition) to the end of the PTSD stress reactivity conditions. |
|
| Primary |
Change in anxiety, as measured by blood pressure (systolic and diastolic), by treatment group during alcohol cue induced craving. |
Anxiety is measured via blood pressure (systolic and diastolic). Participants will undergo an alcohol cue reactivity condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in blood pressure is computed as the difference in measurements taken across the alcohol reactivity conditions to the measurement collected immediately prior to the alcohol reactivity condition. |
On each Test Day (1-3), from baseline (prior to alcohol reactivity conditions) to assessments conducted immediately after the alcohol reactivity conditions. |
|
| Primary |
Change in anxiety, as measured by heart rate, by treatment group during alcohol cue induced craving. |
Anxiety is measured via heart rate. Participants will undergo an alcohol cue reactivity condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in heart rate is computed as the difference in measurements taken across the alcohol reactivity conditions to the measurement collected immediately prior to the alcohol reactivity condition. |
On each Test Day (1-3), from baseline (prior to alcohol reactivity conditions) to assessments conducted immediately after the alcohol reactivity conditions. |
|
| Primary |
Change in anxiety, as measured by the State Trait Anxiety Inventory (STAI-6), by treatment group during alcohol cue induced craving. |
Anxiety is measured via the State Trait Anxiety Inventory (STAI-6). Participants will undergo an alcohol cue reactivity condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in STAI-6 score is computed as the difference in measurements taken across the alcohol reactivity conditions to the measurement collected immediately prior to the alcohol reactivity conditions. |
On each Test Day (1-3), from baseline (prior to alcohol reactivity conditions) to assessments conducted immediately after the alcohol reactivity conditions. |
|
| Primary |
Change in alcohol craving, as measured by the Yale Craving Scale (YCS), by treatment group during alcohol cue induced craving. |
Alcohol craving is measured via the Yale Craving Scale (score range is 0 to 112, with 0 meaning "no sensation" and 112 meaning "strongest imaginable sensation of any kind"). Participants will undergo an alcohol cue reactivity condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in YCS is computed as the difference in measurements taken across the alcohol reactivity conditions to the measurement collected immediately prior to the alcohol reactivity conditions |
On each Test Day (1-3), from baseline (prior to alcohol reactivity conditions) to assessments conducted immediately after the alcohol reactivity conditions. |
|
| Primary |
Change in mood disturbance, as measured by Drugs Effects Questionnaire (DEQ), by treatment group during alcohol cue induced craving. |
Mood disturbance is measured via the Drugs Effects Questionnaire (DEQ). Participants will undergo an alcohol cue reactivity condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in DEQ is computed as the difference in measurements taken across the alcohol cue reactivity condition to the measurement collected immediately prior to the alcohol cue reactivity condition. |
On each Test Day (1-3), from baseline (prior to alcohol reactivity conditions) to assessments conducted immediately after the alcohol reactivity conditions. |
|
| Primary |
Change in mood disturbance, as measured by Visual Analog Scale (VAS), by treatment group during alcohol cue induced craving. |
Mood disturbance is measured via the Visual Analog Scale (score range is 0 to 100, with 0 having no specific mood disturbance and 100 having extreme specific mood disturbance). Participants will undergo an alcohol cue reactivity condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in VAS is computed as the difference in measurements taken across the alcohol cue reactivity condition to the measurement collected immediately prior to the alcohol cue reactivity condition. |
On each Test Day (1-3), from baseline (prior to alcohol reactivity conditions) to assessments conducted immediately after the alcohol reactivity conditions. |
|
| Primary |
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the Biphasic Alcohol Effects Scale (BAES), in the presence of ethanol. |
The BAES is a 14-item self-report adjective rating scale that will serve to measure stimulant and sedative effects of alcohol. The Stimulation subscale score range is 0 to 70, with higher scores indicating greater stimulation. The Sedation subscale score range is 0 to 70, with higher scores indicating greater sedation. Participants will undergo alcohol infusion condition on laboratory test days 1, 2, and 3 (receiving either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), change in BAES score is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to the alcohol infusion. Differences in the change in BAES score will be compared across all three treatment arms. |
On each Test Day (1-3), from baseline (prior to alcohol infusion start) to assessments conducted immediately after the alcohol infusion. |
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| Primary |
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the Number of Drinks Scale (NDS), in the presence of ethanol. |
Self-rated alcohol intoxication is measured by the Number of Drinks Scale (NDS). The NDS assess how many drinks the subject feels he/she has consumed at a specific timepoint (the higher the number the greater the alcohol intoxication). Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in NDS score is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to the alcohol infusion. Differences in the change in NDS score will be compared across all three treatment arms. |
On each Test Day (1-3), from baseline (prior to alcohol infusion start) to assessments conducted immediately after the alcohol infusion. |
|
| Primary |
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the State Trait Anxiety Inventory (STAI-6), in the presence of ethanol. |
The STAI-6 is a 6-item measure designed to assess trait and state aspects of anxiety. Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in STAI-6 score is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to the alcohol infusion. Differences in the change in STAI-6 score will be compared across all three treatment arms. |
On each Test Day (1-3), from baseline (prior to alcohol infusion start) to assessments conducted immediately after the alcohol infusion. |
|
| Primary |
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the Drug Effects Questionnaire (DEQ), in the presence of ethanol. |
The DEQ is a 5-item self-report measure used to assess the two key aspects of the subjective experience of substance effects: (1) the strength of substance effects and (2) the desirability of substance effects. Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in DEQ score is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to the alcohol infusion. Differences in the change in DEQ score will be compared across all three treatment arms. |
On each Test Day (1-3), from baseline (prior to alcohol infusion start) to assessments conducted immediately after the alcohol infusion. |
|
| Primary |
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the Yale Craving Scale (YCS), in the presence of ethanol. |
Alcohol craving is measured via the Yale Craving Scale (score range is 0 to 112, with 0 meaning "no sensation" and 112 meaning "strongest imaginable sensation of any kind"). Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in YCS score is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to the alcohol infusion. Differences in the change in YCS score will be compared across all three treatment arms. |
On each Test Day (1-3), from baseline (prior to alcohol infusion start) to assessments conducted immediately after the alcohol infusion. |
|
| Primary |
Evaluate whether pretreatment with BXCL501 alters subjective effects, as measured by the Visual Analog Scale (VAS), in the presence of ethanol. |
Mood disturbance is measured via the Visual Analog Scale (score range is 0 to 100, with 0 having no specific mood disturbance and 100 having extreme specific mood disturbance). Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in VAS score is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to the alcohol infusion. Differences in the change in VAS score will be compared across all three treatment arms. |
On each Test Day (1-3), from baseline (prior to alcohol infusion start) to assessments conducted immediately after the alcohol infusion. |
|
| Primary |
Evaluate whether pretreatment with BXCL501 alters motor impairment, as measured by the Grooved Pegboard (GPB), in the presence of ethanol. |
The GPB is a manipulative dexterity test, consisting of a board with randomly positioned slots in which subjects insert pegs. It is an eye-to-hand coordination test that has been used in research studies to measure motor skills. Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in GPB score is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to drug administration. Differences in the change in GPB score will be compared across all three treatment arms. |
On each Test Day (1-3), from baseline (prior to drug administration) to assessments conducted immediately after the alcohol infusion. |
|
| Primary |
Evaluate whether pretreatment with BXCL501 alters cognitive functioning, as measured by the Rapid Information Processing Task (RVIP), in the presence of ethanol. |
The RVIP is a widely used task to assess sustained attention, with a working memory component. These cognitive functions are sensitive to acute alcohol administration. Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in RVIP score is computed as the difference in the RVIP measurement taken once the targeted BAL is achieved during the alcohol infusion to the measurement collected immediately prior to drug administration. |
On each Test Day (1-3), from baseline (prior to drug administration) to the RVIP assessment conducted immediately after the targeted BAL is reached during the alcohol infusion. |
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| Primary |
Evaluate whether pretreatment with BXCL501 alters cognitive functioning, as measured by the Hopkins Verbal Learning Test-Revised (HVLT-R), in the presence of ethanol. |
The HVLT-R is a word list learning test of verbal memory and is sensitive to the acute effects of alcohol. Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in HVLT-R score is computed as the difference in the HVLT-R measurement taken once the targeted BAL is achieved during the alcohol infusion to the measurement collected immediately prior to drug administration. |
On each Test Day (1-3), from baseline (prior to drug administration) to the HVLT-R assessment conducted immediately after the targeted BAL is reached during the alcohol infusion. |
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| Primary |
Evaluate whether pretreatment with BXCL501 alters cognitive functioning, as measured by the Go No-Go Task, in the presence of ethanol. |
The Go No-Go task will assess the ability to withhold responses to an infrequently occurring target (No-Go trials). Alcohol has been shown to impair responses to Go No-Go task. Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in Go No-Go score is computed as the difference in the Go No-Go measurement taken once the targeted BAL is achieved during the alcohol infusion to the measurement collected immediately prior to drug administration. |
On each Test Day (1-3), from baseline (prior to drug administration) to the Go No-Go assessment conducted immediately after the targeted BAL is reached during the alcohol infusion. |
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| Primary |
Evaluate whether pretreatment with BXCL501 increases side effects, as measured by blood pressure (systolic and diastolic), in the presence of ethanol. |
Potential side-effects of BXCL501 in the presence of alcohol will be measured via blood pressure. Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in blood pressure is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to the alcohol infusion. |
On each Test Day (1-3), from baseline (prior to alcohol infusion) to the blood pressure measurement taken after completion of the alcohol infusion. |
|
| Primary |
Evaluate whether pretreatment with BXCL501 increases side effects, as measured by heart rate, in the presence of ethanol. |
Potential side-effects of BXCL501 in the presence of alcohol will be measured via heart rate. Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in heart rate is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to the alcohol infusion. |
On each Test Day (1-3), from baseline (prior to alcohol infusion) to the heart rate measurement taken after completion of the alcohol infusion. |
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| Primary |
Evaluate whether pretreatment with BXCL501 increases side effects, as measured by the Richmond Agitation Sedation Scale (RASS), in the presence of ethanol. |
Potential side-effects of BXCL501 in the presence of alcohol will be measured via the RASS, which is assessed by clinic staff to measure participant's level of sedation. The score range is +4 (combative) to -5 (unarousable), thus lower scores indicate greater sedation. Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in RASS score is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to the alcohol infusion. |
On each Test Day (1-3), from baseline (prior to alcohol infusion) to the RASS measurement taken after completion of the alcohol infusion. |
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| Primary |
Evaluate whether pretreatment with BXCL501 increases side effects, as measured by the Agitation-Calmness Evaluation Scale (ACES), in the presence of ethanol. |
Potential side-effects of BXCL501 in the presence of alcohol will be measured via the ACES, which is assessed by clinic staff to measure participants' level of sedation. The score range is 1 (marked agitation) to 9 (unarousable), thus higher scores indicate greater sedation. Participants will undergo an alcohol infusion condition on laboratory test days 1, 2, and 3 (where participant receives either BXCL501 40µg, 80µg, or placebo in a randomized fashion each day). For each test day (1-3), the change in ACES score is computed as the difference in measurements taken across the alcohol infusion to the measurement collected immediately prior to the alcohol infusion. |
On each Test Day (1-3), from baseline (prior to alcohol infusion) to the ACES measurement taken after completion of the alcohol infusion. |
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