Clinical trial NCT06326684: Suvorexant and Alcohol
Official title: Influence of Orexin Antagonism on Motivation for Alcohol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Alcohol Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reinforcing Effects of Alcohol
timeFrame: 6 times over approximately 2.5 week inpatient admission.
Secondary outcomes:
measure: Craving
timeFrame: 6 times over approximately 2.5 week inpatient admission.
measure: Mood
timeFrame: 6 times over approximately 2.5 week inpatient admission.
measure: Alcohol Response
timeFrame: 6 times over approximately 2.5 week inpatient admission.
measure: Heart rate
timeFrame: Daily over approximately 2.5 week inpatient admission.
measure: Blood pressure
timeFrame: Daily over approximately 2.5 week inpatient admission.
measure: Breath Alcohol Level
timeFrame: Daily over approximately 2.5 week inpatient admission.
measure: Temperature
timeFrame: Daily over approximately 2.5 week inpatient admission.
measure: Side Effects
timeFrame: Daily over approximately 2.5 week inpatient admission.
measure: Delay Discounting
timeFrame: 6 times over approximately 2.5 week inpatient admission.
measure: n-back Task
timeFrame: 6 times over approximately 2.5 week inpatient admission.
measure: Stop-Signal Task Inhibitory Failures
timeFrame: 6 times over approximately 2.5 week inpatient admission.
measure: Sleep
timeFrame: Daily over approximately 2.5 week inpatient admission.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Psychopharmacology of Addiction Laboratory
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: William W Stoops, PhD
role: PRINCIPAL_INVESTIGATOR
References: