Trial Outcomes & Findings for Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep (NCT NCT05458609)
NCT ID: NCT05458609
Last Updated: 2026-03-24
Results Overview
Alcohol Urge Questionnaire (AUQ) total score (range 8-56; higher scores indicate greater craving) was assessed following alcohol-related virtual reality cue exposure at baseline and at multiple post-baseline time points during treatment. For this outcome, change from baseline to the last available post-baseline AUQ assessment was calculated and reported as a single summary value.
COMPLETED
PHASE3
8 participants
Baseline to last available post-baseline assessment (2 to 4 weeks after randomization)
2026-03-24
Participant Flow
Seven participants were randomized, six participants initiated medication.
After enrollment, participants underwent standard inpatient clinical evaluation and screening procedures to confirm eligibility, including diagnostic assessment and review of medical and laboratory data. Participants who did not meet eligibility criteria or did not proceed to initiation of study medication due to loss of follow-up were not assigned to a treatment arm. No washout or run-in period was required prior to randomization.
Participant milestones
| Measure |
Lemborexant Plus Naltrexone
10 milligrams of Lemborexant will be given daily at nighttime and 50 milligrams of Naltrexone will be given daily for 2 to 4 weeks
|
Placebo Plus Naltrexone
10 milligrams of placebo will be given daily at nighttime and 50 milligrams of Naltrexone will be given daily for 2 to 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
Treated
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lemborexant Plus Naltrexone
10 milligrams of Lemborexant will be given daily at nighttime and 50 milligrams of Naltrexone will be given daily for 2 to 4 weeks
|
Placebo Plus Naltrexone
10 milligrams of placebo will be given daily at nighttime and 50 milligrams of Naltrexone will be given daily for 2 to 4 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
All randomized participants with available baseline Alcohol Dependence Scale (ADS) data.
Baseline characteristics by cohort
| Measure |
Lemborexant Plus Naltrexone
n=4 Participants
10 milligrams of Lemborexant will be given daily at nighttime and 50 milligrams of Naltrexone will be given daily for 2 to 4 weeks
|
Placebo Plus Naltrexone
n=3 Participants
10 milligrams of placebo will be given daily at nighttime and 50 milligrams of Naltrexone will be given daily for a total of 4 weeks
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
|
Alcohol Dependence Scale
|
27.25 Scores on a scale
STANDARD_DEVIATION 9.60 • n=138 Participants • All randomized participants with available baseline Alcohol Dependence Scale (ADS) data.
|
23.67 Scores on a scale
STANDARD_DEVIATION 5.13 • n=62 Participants • All randomized participants with available baseline Alcohol Dependence Scale (ADS) data.
|
25.71 Scores on a scale
STANDARD_DEVIATION 7.65 • n=123 Participants • All randomized participants with available baseline Alcohol Dependence Scale (ADS) data.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=138 Participants
|
3 Participants
n=62 Participants
|
6 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: Baseline to last available post-baseline assessment (2 to 4 weeks after randomization)Population: Randomized participants who initiated study medication and had available baseline and at least one post-baseline Alcohol Urge Questionnaire (AUQ) assessment. Participants who did not initiate study medication were excluded from this analysis.
Alcohol Urge Questionnaire (AUQ) total score (range 8-56; higher scores indicate greater craving) was assessed following alcohol-related virtual reality cue exposure at baseline and at multiple post-baseline time points during treatment. For this outcome, change from baseline to the last available post-baseline AUQ assessment was calculated and reported as a single summary value.
Outcome measures
| Measure |
Lemborexant Plus Naltrexone
n=3 Participants
10 milligrams of Lemborexant was given daily at nighttime and 50 milligrams of Naltrexone was given daily for 2 to 4 weeks
|
Placebo Plus Naltrexone
n=3 Participants
10 milligrams of placebo was given daily at nighttime and 50 milligrams of Naltrexone was given daily for 2 to 4 weeks
|
|---|---|---|
|
Cue-induced Alcohol Cravings Using the Alcohol Urge Questionnaire
|
-22.67 score on a scale
Standard Deviation 16.77
|
-23.67 score on a scale
Standard Deviation 21.94
|
PRIMARY outcome
Timeframe: Baseline to study endpoint (2 to 4 weeks after randomization)Penn Alcohol Craving Scale (PACS): The Penn Alcohol Craving Scale is a 5-item self-report questionnaire assessing alcohol craving over the prior week. Total scores range from 0 to 30, with higher scores indicating greater alcohol craving. PACS assessments were obtained at baseline and weekly during the treatment period. For this outcome, change from baseline to the endpoint PACS assessment was calculated and reported as a single summary value.
Outcome measures
| Measure |
Lemborexant Plus Naltrexone
n=3 Participants
10 milligrams of Lemborexant was given daily at nighttime and 50 milligrams of Naltrexone was given daily for 2 to 4 weeks
|
Placebo Plus Naltrexone
n=3 Participants
10 milligrams of placebo was given daily at nighttime and 50 milligrams of Naltrexone was given daily for 2 to 4 weeks
|
|---|---|---|
|
Non-Cued Alcohol Cravings Using the Penn Alcohol Craving Scale
|
-14.00 score on a scale
Standard Deviation 2.65
|
-12.33 score on a scale
Standard Deviation 9.87
|
SECONDARY outcome
Timeframe: Baseline to study endpoint (2 to 4 weeks after randomization)The ActiGraph wGT3X-BT will measure daily total sleep time (hours)
Outcome measures
| Measure |
Lemborexant Plus Naltrexone
n=3 Participants
10 milligrams of Lemborexant was given daily at nighttime and 50 milligrams of Naltrexone was given daily for 2 to 4 weeks
|
Placebo Plus Naltrexone
n=3 Participants
10 milligrams of placebo was given daily at nighttime and 50 milligrams of Naltrexone was given daily for 2 to 4 weeks
|
|---|---|---|
|
Actigraphy to Measure Total Sleep Time
|
8.40 hours per night
Standard Deviation 0.85
|
8.75 hours per night
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Baseline to study endpoint (2 to 4 weeks after randomization)The ActiGraph wGT3X-BT will measure total number of awakenings after sleep onset during the study period
Outcome measures
| Measure |
Lemborexant Plus Naltrexone
n=3 Participants
10 milligrams of Lemborexant was given daily at nighttime and 50 milligrams of Naltrexone was given daily for 2 to 4 weeks
|
Placebo Plus Naltrexone
n=3 Participants
10 milligrams of placebo was given daily at nighttime and 50 milligrams of Naltrexone was given daily for 2 to 4 weeks
|
|---|---|---|
|
Actigraphy to Measure Total Awakenings After Sleep Onset During the Study Period
|
237.67 Number of awakenings
Standard Deviation 144.31
|
422.00 Number of awakenings
Standard Deviation 294.05
|
Adverse Events
Lemborexant Plus Naltrexone
Placebo Plus Naltrexone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lemborexant Plus Naltrexone
n=3 participants at risk
10 milligrams of Lemborexant was given daily at nighttime and 50 milligrams of Naltrexone was given daily for 2 to 4 weeks
|
Placebo Plus Naltrexone
n=3 participants at risk
10 milligrams of placebo was given daily at nighttime and 50 milligrams of Naltrexone was given daily for 2 to 4 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • from enrollment until end of follow-up, up to 4 weeks
|
33.3%
1/3 • Number of events 1 • from enrollment until end of follow-up, up to 4 weeks
|
|
Skin and subcutaneous tissue disorders
skin discomfort
|
33.3%
1/3 • Number of events 1 • from enrollment until end of follow-up, up to 4 weeks
|
0.00%
0/3 • from enrollment until end of follow-up, up to 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place