Suvorexant and Alcohol

Early Phase 1RecruitingNCT06326684

William Stoops30 enrolled

Overview

This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Alcohol Use Disorder

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion/Exclusion Criteria: 1. Able to speak and read English. 2. Not seeking treatment at the time of the study. 3. Between the ages of 21 and 55 years. 4. Engaging in at least one binge drinking episode, per the NIAAA definition, in the last 30 days. 5. Fulfillment of moderate or severe DSM-5 diagnostic criteria for AUD based on computerized SCID results reviewed by a psychiatrist or psychologist. 6. ECG, read by cardiologist, within normal limits. 7. Body mass index of 19 - 35. 8. Birthing individuals using an effective form of birth control and not pregnant or breast feeding. 9. Judged by the medical staff to be psychiatrically and physically healthy (i.e., no current severe SUD or psychiatric diagnoses other than AUD or Tobacco Use Disorder; no current physical diagnoses that would interfere with study participation according to study physician judgment). 10. Not currently physiologically dependent on any substances. 11. Able to abstain from alcohol during admission (i.e., not physically dependent on alcohol and scores less than 8 on Clinical Institute Withdrawal Assessment for Alcohol \[CIWA-Ar\] at screening). 12. Not currently taking any prescribed medications for a chronic condition (other than birth control). 13. No indication of sleep apnea on the STOP-Bang questionnaire (score of 5 or greater). 14. No contraindications/allergies to suvorexant.

Outcomes

Primary Outcomes

Reinforcing Effects of Alcohol

Number of Times Subjects Choose Alcohol (Maximum of 5 Choices) Over Money

Time frame: 6 times over approximately 3 week inpatient admission.

Secondary Outcomes

Craving

Subjects will report their craving during 6 sessions while they are admitted to our inpatient unit. Measured using a 10 point craving questionnaire with higher scores meaning greater craving.

Time frame: 6 times over approximately 3 week inpatient admission.

Mood

Subjects will complete the Profile of Mood States during 6 sessions while they are admitted to our inpatient unit. Scores range from 0 to 4 with higher scores indicating stronger mood.

Time frame: 6 times over approximately 3 week inpatient admission.

Alcohol Response

Subjects will complete the Biphasic Alcohol Effects Scale during 6 sessions while they are admitted to our inpatient unit. Scores range from 0 to 10 with higher scores indicating greater responses.

Time frame: 6 times over approximately 3 week inpatient admission.

Heart rate

Beats per minute. Measured daily during inpatient admission.

Time frame: Daily over approximately 3 week inpatient admission.

Blood pressure

mm Hg. Measured daily during inpatient admission.

Time frame: Daily over approximately 3 week inpatient admission.

Breath Alcohol Level

Percent. Measured daily during inpatient admission.

Time frame: Daily over approximately 3 week inpatient admission.

Temperature

Degrees Fahrenheit. Measured daily during inpatient admission.

Time frame: Daily over approximately 3 week inpatient admission.

Side Effects

Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.

Time frame: Daily over approximately 3 week inpatient admission.

Delay Discounting

Subjects will complete the delay discounting task during 6 sessions while they are admitted to our inpatient unit. Responses will be used to calculate discounting slope (i.e., K).

Time frame: 6 times over approximately 3 week inpatient admission.

n-back Task

Subjects will complete the n-back task during 6 sessions while they are admitted to our inpatient unit. Percentage of correct responses will be the outcome.

Time frame: 6 times over approximately 3 week inpatient admission.

Stop-Signal Task Inhibitory Failures

Subjects will complete the stop-signal task during 6 sessions while they are admitted to our inpatient unit. Proportion of inhibitory failures will be the outcome variable.

Time frame: 6 times over approximately 3 week inpatient admission.

Sleep

Subjects will complete the St. Mary's Sleep Questionnaire daily while they are admitted to our inpatient unit. Total sleep time will be the outcome variable and will be recorded in minutes. Higher scores indicate more sleep. Total sleep time is measured by self-report; minimum score=0, maximum score=1440 per day.

Time frame: Daily over approximately 3 week inpatient admission.

Suvorexant and Alcohol

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts