Trial Outcomes & Findings for Medication Development in Alcoholism: Suvorexant Versus Placebo (NCT NCT04229095)

Last Updated: 2023-04-26

Results Overview

VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

1 hour during cue reactivity session

Results posted on

2023-04-26

Participant Flow

Subjects were recruited for study participation at the Laboratory of Clinical Psychopharmacology at The Scripps Research Institute in La Jolla, California from 09/30/2021-11/08/2022.

Thirty-two subjects did not meet admission criteria and 12 subjects declined participation.

Participant milestones

Participant milestones
Measure	Belsomra,(Suvorexant) 20 mg single-dose administration given on an inpatient clinical research unit Suvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit	Placebo, (Sugar Pill) Placebo single-dose administration given on an inpatient clinical research unit Placebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit
Overall Study STARTED	14	12
Overall Study COMPLETED	14	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Medication Development in Alcoholism: Suvorexant Versus Placebo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belsomra,(Suvorexant) n=14 Participants 20 mg single-dose administration given on an inpatient clinical research unit Suvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit	Placebo, (Sugar Pill) n=12 Participants Placebo single-dose administration given on an inpatient clinical research unit Placebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit	Total n=26 Participants Total of all reporting groups
Age, Continuous	36.29 years STANDARD_DEVIATION 11.7 • n=99 Participants	38.83 years STANDARD_DEVIATION 11.0 • n=107 Participants	37.46 years STANDARD_DEVIATION 11.2 • n=206 Participants
Sex: Female, Male Female	6 Participants n=99 Participants	7 Participants n=107 Participants	13 Participants n=206 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	5 Participants n=107 Participants	13 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=99 Participants	3 Participants n=107 Participants	11 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=99 Participants	9 Participants n=107 Participants	15 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	9 Participants n=99 Participants	8 Participants n=107 Participants	17 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment United States	14 Participants n=99 Participants	12 Participants n=107 Participants	26 Participants n=206 Participants
DSM-V symptom Count	6.43 symptom count STANDARD_DEVIATION 2.1 • n=99 Participants	8.08 symptom count STANDARD_DEVIATION 2.0 • n=107 Participants	7.19 symptom count STANDARD_DEVIATION 2.2 • n=206 Participants

PRIMARY outcome

Timeframe: 1 hour during cue reactivity session

VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.

Outcome measures

Outcome measures
Measure	Belsomra,(Suvorexant) n=14 Participants 20 mg single-dose administration given on an inpatient clinical research unit Suvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit	Placebo n=12 Participants Placebo single-dose administration given on an inpatient clinical research unit Placebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit
Visual Analogue Scale (VAS) of Craving Severity: 2 Arms	2.38 score on a scale Standard Error 0.90	1.44 score on a scale Standard Error 0.62

PRIMARY outcome

Timeframe: 1 hour during cue reactivity session

Population: All randomized subjects

VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.

Outcome measures

Outcome measures
Measure	Belsomra,(Suvorexant) n=26 Participants 20 mg single-dose administration given on an inpatient clinical research unit Suvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit	Placebo Placebo single-dose administration given on an inpatient clinical research unit Placebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit
Visual Analog Scale (VAS) Strength of Craving: Combined Arms Conditional Model	.94 score on a scale	—

SECONDARY outcome

Timeframe: Up to one week following single dose administration

Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcohol drinks consumed per day with a minimum value of 0 and an undetermined maximum value

Outcome measures

Outcome measures
Measure	Belsomra,(Suvorexant) n=14 Participants 20 mg single-dose administration given on an inpatient clinical research unit Suvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit	Placebo n=12 Participants Placebo single-dose administration given on an inpatient clinical research unit Placebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit
Number of Standard Drinks Per Day: 2 Arms	3.59 Standard drinks per day Standard Error 0.87	3.46 Standard drinks per day Standard Error 0.88

SECONDARY outcome

Timeframe: Up to one week following single dose administration

Population: Of the 26 subjects randomized, all 17 subjects that had any follow up drinking data were included in this analysis.

Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value.

Outcome measures

Outcome measures
Measure	Belsomra,(Suvorexant) n=17 Participants 20 mg single-dose administration given on an inpatient clinical research unit Suvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit	Placebo Placebo single-dose administration given on an inpatient clinical research unit Placebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit
Number of Standard Drinks Per Day: Combined Arms Conditional Model	-1.52 number of standard drinks per day	—

Adverse Events

Belsomra,(Suvorexant)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo, (Sugar Pill)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Belsomra,(Suvorexant) n=14 participants at risk 20 mg single-dose administration given on an inpatient clinical research unit Suvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit	Placebo, (Sugar Pill) n=12 participants at risk Placebo single-dose administration given on an inpatient clinical research unit Placebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit
Gastrointestinal disorders Abdominal pain upper	14.3% 2/14 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.	8.3% 1/12 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.
Gastrointestinal disorders Diarrhea	14.3% 2/14 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/12 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.
General disorders Feeling cold	0.00% 0/14 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.	8.3% 1/12 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.
Nervous system disorders Headache	14.3% 2/14 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.	8.3% 1/12 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.
Nervous system disorders Somnolence	28.6% 4/14 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.	25.0% 3/12 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.
Nervous system disorders Vivid dreams	7.1% 1/14 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/12 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.
Psychiatric disorders Mental fatigue	7.1% 1/14 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.	16.7% 2/12 • Adverse event data was collected at all study visits, for any average duration of 3 weeks. Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.

Additional Information

Dr. Barbara J. Mason, Ph.D. Professor

The Scripps Research Institute

Phone: (858 784-7324

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place