A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users


Original post, click here
  • Mean time to peak effect (TEmax) score for Drug Liking on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, my liking for this drug is.” The VAS will be scored as an integer from 0 (strong disliking) to 100 (strong liking). The neutral point equals 50 and will be labeled with the anchor “neither like nor dislike.”

  • Mean peak minimum effect (Emin) score for Drug Liking on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, my liking for this drug is.” The VAS will be scored as an integer from 0 (strong disliking) to 100 (strong liking). The neutral point equals 50 and will be labeled with the anchor “neither like nor dislike.”

  • Mean time to peak minimum effect (TEmin) score for Drug Liking on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, my liking for this drug is.” The VAS will be scored as an integer from 0 (strong disliking) to 100 (strong liking). The neutral point equals 50 and will be labeled with the anchor “neither like nor dislike.”

  • Mean time-averaged area under the effects curve (TA_AUE) score for Drug Liking on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, my liking for this drug is.” The VAS will be scored as an integer from 0 (strong disliking) to 100 (strong liking). The neutral point equals 50 and will be labeled with the anchor “neither like nor dislike.”

  • Mean Emax score for Overall Drug Liking (Overall, my liking for this drug is) on a VAS [ Time Frame: 12 (Day 1), 24 (Day 2), and 48 hours (Day 3) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “Overall, my liking for this drug is.” The VAS will be scored as an integer from 0 (strong disliking) to 100 (strong liking). The neutral point equals 50 and will be labeled with the anchor “neither like nor dislike.”

  • Mean Emax score for taking the drug again on a VAS [ Time Frame: 12 (Day 1), 24 (Day 2), and 48 hours (Day 3) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “I would take this drug again.” The VAS will be scored as an integer from 0 (definitely not) to 100 (definitely so). The neutral point equals 50 and will be labeled with the anchor “neutral.”

  • Mean Emax score for Subjective Drug Value (SDV) [ Time Frame: 12 (Day 1), 24 (Day 2), and 48 hours (Day 3) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to choose between theoretically receiving another dose of the drug to take home or an envelope containing a specified amount of money. Depending on the answer to each question, the monetary value in the next question will be either higher or lower.

  • Mean Emax score for Good Effects on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel good drug effects.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean TEmax score for Good Effects on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel good drug effects.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean TA_AUE score for Good Effects on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel good drug effects.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean Emax score for Feeling Stoned on a VAS [ Time Frame: Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel stoned.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean TEmax score for Feeling Stoned on a VAS [ Time Frame: Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel stoned.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean TA_AUE score for Feeling Stoned on a VAS [ Time Frame: Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel stoned.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean Emax score for Feeling High on a VAS [ Time Frame: Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel high.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean TEmax score for Feeling High on a VAS [ Time Frame: Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel high.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean TA_AUE score for Feeling High on a VAS [ Time Frame: Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel high.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean Emax score for Bad Effects on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel bad drug effects.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean TEmax score for Bad Effects on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel bad drug effects.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean TA_AUE score for Bad Effects on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel bad drug effects.” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely).

  • Mean Emax score for Sedative Effect on a VAS [ Time Frame: Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, my mental state is….” The VAS will be scored as an integer from 0 (very drowsy) to 100 (very alert). The neutral point equals 50 and will be labeled with “Neither drowsy nor alert.”

  • Mean TEmax score for Sedative Effect on a VAS [ Time Frame: Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, my mental state is….” The VAS will be scored as an integer from 0 (very drowsy) to 100 (very alert). The neutral point equals 50 and will be labeled with “Neither drowsy nor alert.”

  • Mean TA_AUE score for Sedative Effect on a VAS [ Time Frame: Pre-dose; 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, my mental state is….” The VAS will be scored as an integer from 0 (very drowsy) to 100 (very alert). The neutral point equals 50 and will be labeled with “Neither drowsy nor alert.”

  • Mean Emax for Addiction Research Center Inventory (ARCI) Pentobarbital-Chlorpromazine-Alcohol Group (PCAG) subscale score [ Time Frame: 1, 2, 4, and 8 hours (all Day 1) post-dose of each treatment cycle (up to 11 weeks) ]

    The shortened version of the ARCI contains the PCAG scale, consisting of 15 items measuring sedation effects. Participants indicate their responses by selecting “True” or “False” with a mouse. One point is given for each response that agrees with the scoring direction on the scale (i.e., True items receive a score of 1 if the answer is “True”; False items receive a score of 1 if the answer is “False”; no points are given when the answer is opposite to the scoring direction).

  • Mean TEmax for ARCI PCAG subscale score [ Time Frame: 1, 2, 4, and 8 hours (all Day 1) post-dose of each treatment cycle (up to 11 weeks) ]

    The shortened version of the ARCI contains the PCAG scale, consisting of 15 items measuring sedation effects. Participants indicate their responses by selecting “True” or “False” with a mouse. One point is given for each response that agrees with the scoring direction on the scale (i.e., True items receive a score of 1 if the answer is “True”; False items receive a score of 1 if the answer is “False”; no points are given when the answer is opposite to the scoring direction).

  • Mean TA-AUE for ARCI PCAG subscale score [ Time Frame: 1, 2, 4, and 8 hours (all Day 1) post-dose of each treatment cycle (up to 11 weeks) ]

    The shortened version of the ARCI contains the PCAG scale, consisting of 15 items measuring sedation effects. Participants indicate their responses by selecting “True” or “False” with a mouse. One point is given for each response that agrees with the scoring direction on the scale (i.e., True items receive a score of 1 if the answer is “True”; False items receive a score of 1 if the answer is “False”; no points are given when the answer is opposite to the scoring direction).

  • Mean Emax score for Any Effects on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel any drug effect” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely)

  • Mean TEmax score for Any Effects on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel any drug effect” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely)

  • Mean TA_AUE score for Any Effects on a VAS [ Time Frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    Analysis will be conducted to evaluate objective and subjective effects related to abuse potential. Participants will be asked to respond to the following question on a VAS: “At this moment, I feel any drug effect” The VAS will be scored as an integer from 0 (not at all) to 100 (extremely)

  • Mean Emax score for Observer’s Assessment of Alertness/Sedation (OAA/S): composite and sum scores [ Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    The OAA/S Scale was developed to measure the level of alertness in participants who are sedated. The OAA/S scale is composed of the following assessment categories: responsiveness, speech, facial expression, and eyes. The OAA/S scale will be scored in 2 ways: a composite score (from 1 [less alert] to 5 [alert]), defined as the lowest score in any one of the 4 assessment categories; and a sum score, which is calculated as the total of the scores in the 4 assessment categories (from 4 [less alert] to 20 [more alert]).

  • Mean TA_AUE score for OAA/S: composite and sum scores [ Time Frame: Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    The OAA/S Scale was developed to measure the level of alertness in participants who are sedated. The OAA/S scale is composed of the following assessment categories: responsiveness, speech, facial expression, and eyes. The OAA/S scale will be scored in 2 ways: a composite score (from 1 [less alert] to 5 [alert]), defined as the lowest score in any one of the 4 assessment categories; and a sum score, which is calculated as the total of the scores in the 4 assessment categories (from 4 [less alert] to 20 [more alert]).

  • Maximum change from baseline (CFBmax) in Choice Reaction Time (CRT) score (Motor Reaction Time [MRT] subscale score, Recognition Reaction Time [RRT] subscale score, and Total Reaction Time [TRT] subscale score) [ Time Frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    The CRT task is a classic test of reaction time used to measure psychomotor performance. During this test, the participant is presented with an onscreen equivalent of the numeric keypad. The participant must quickly press the buttons on a separate keypad that corresponds with the keys illuminated on the screen. The CRT task comprises 3 outcome variables: RRT, MRT, and TRT. RRT is the time it takes for a participant to notice the light (i.e., the time between stimulus onset and the participant lifting his or her finger from the start button). MRT indexes the movement component of this task and is the time between the participant lifting his or her finger from the start button and touching the response button. TRT is the sum of RRT and MRT.

  • Mean TA_AUE of CRT score (MRT subscale score, RRT subscale score, and TRT subscale score) [ Time Frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    The CRT task is a classic test of reaction time used to measure psychomotor performance. During this test, the participant is presented with an onscreen equivalent of the numeric keypad. The participant must quickly press the buttons on a separate keypad that corresponds with the keys illuminated on the screen. The CRT task comprises 3 outcome variables: RRT, MRT, and TRT. RRT is the time it takes for a participant to notice the light (i.e., the time between stimulus onset and the participant lifting his or her finger from the start button). MRT indexes the movement component of this task and is the time between the participant lifting his or her finger from the start button and touching the response button. TRT is the sum of RRT and MRT.

  • Minimum change from baseline (CFBmin) of percentage correct response relative to CRT score (MRT subscale score, RRT subscale score, and TRT subscale score) [ Time Frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    The CRT task is a classic test of reaction time used to measure psychomotor performance. During this test, the participant is presented with an onscreen equivalent of the numeric keypad. The participant must quickly press the buttons on a separate keypad that corresponds with the keys illuminated on the screen. The CRT task comprises 3 outcome variables: RRT, MRT, and TRT. RRT is the time it takes for a participant to notice the light (i.e., the time between stimulus onset and the participant lifting his or her finger from the start button). MRT indexes the movement component of this task and is the time between the participant lifting his or her finger from the start button and touching the response button. TRT is the sum of RRT and MRT.

  • Mean TA_AUE of percentage correct response relative to CRT score (MRT subscale score, RRT subscale score, and TRT subscale score) [ Time Frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    The CRT task is a classic test of reaction time used to measure psychomotor performance. During this test, the participant is presented with an onscreen equivalent of the numeric keypad. The participant must quickly press the buttons on a separate keypad that corresponds with the keys illuminated on the screen. The CRT task comprises 3 outcome variables: RRT, MRT, and TRT. RRT is the time it takes for a participant to notice the light (i.e., the time between stimulus onset and the participant lifting his or her finger from the start button). MRT indexes the movement component of this task and is the time between the participant lifting his or her finger from the start button and touching the response button. TRT is the sum of RRT and MRT.

  • CFBmax in Divided Attention (DA) score (MRT subscale score, RRT subscale score, and TRT subscale score) [ Time Frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    The DA test is a manual-tracking test with a simultaneous visual target detection component. The participant is provided with a joystick with a trigger to execute this measure. During testing, the participant is presented with the image of an airplane and a randomly curving road. As the road moves down the screen, the participant is to try and position the image of the airplane over the center of the road.

  • Mean TA_AUE of DA score (MRT subscale score, RRT subscale score, and TRT subscale score) [ Time Frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    The DA test is a manual-tracking test with a simultaneous visual target detection component. The participant is provided with a joystick with a trigger to execute this measure. During testing, the participant is presented with the image of an airplane and a randomly curving road. As the road moves down the screen, the participant is to try and position the image of the airplane over the center of the road.

  • CFBmin of percentage correct response relative to CRT score (MRT subscale score, RRT subscale score, and TRT subscale score) [ Time Frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    The DA test is a manual-tracking test with a simultaneous visual target detection component. The participant is provided with a joystick with a trigger to execute this measure. During testing, the participant is presented with the image of an airplane and a randomly curving road. As the road moves down the screen, the participant is to try and position the image of the airplane over the center of the road.

  • Mean TA_AUE of percentage correct response relative to DA score (MRT subscale score, RRT subscale score, and TRT subscale score) [ Time Frame: Pre-dose; 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 (all Day 1), and 24 hours (Day 2) post-dose of each treatment cycle (up to 11 weeks) ]

    The DA test is a manual-tracking test with a simultaneous visual target detection component. The participant is provided with a joystick with a trigger to execute this measure. During testing, the participant is presented with the image of an airplane and a randomly curving road. As the road moves down the screen, the participant is to try and position the image of the airplane over the center of the road.

  • Number of participants with any treatment-emergent adverse event (TEAE) [ Time Frame: Up to 20 weeks ]

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (Baseline) or: re-emerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment; or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

  • Number of participants with any treatment-emergent serious adverse event (SAE) [ Time Frame: up to 20 weeks ]

    A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (Baseline) or: re-emerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment; or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).