Suvorexant and Alcohol

Alcohol Use Disorder Clinical Trial

Official title:

Influence of Orexin Antagonism on Motivation for Alcohol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326684
• Other study ID #: 88524
• Secondary ID: R01AA030775
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 7, 2024
• Est. completion date: March 15, 2027

Study information

• Verified date: June 2024
• Source: University of Kentucky
• Contact: William W Stoops, PhD
• Phone: 8592575388
• Email: william.stoops[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 15, 2027
• Est. primary completion date: March 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Alcohol
The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
• Placebo
The effects of placebo will be determined.
• Suvorexant
The effects of suvorexant dose 1 will be determined.
• Suvorexant
The effects of suvorexant dose 2 will be determined.

Locations

Country	Name	City	State
United States	Psychopharmacology of Addiction Laboratory	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Kentucky	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reinforcing Effects of Alcohol	Number of Times Subjects Choose Alcohol (Maximum of 5 Choices) Over Money	6 times over approximately 2.5 week inpatient admission.
Secondary	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.	6 times over approximately 2.5 week inpatient admission.
Secondary	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.	6 times over approximately 2.5 week inpatient admission.
Secondary	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.	6 times over approximately 2.5 week inpatient admission.
Secondary	Heart rate	Beats per minute. Measured daily during inpatient admission.	Daily over approximately 2.5 week inpatient admission.
Secondary	Blood pressure	mm Hg. Measured daily during inpatient admission.	Daily over approximately 2.5 week inpatient admission.
Secondary	Breath Alcohol Level	Percent. Measured daily during inpatient admission.	Daily over approximately 2.5 week inpatient admission.
Secondary	Temperature	Degrees Fahrenheit. Measured daily during inpatient admission.	Daily over approximately 2.5 week inpatient admission.
Secondary	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.	Daily over approximately 2.5 week inpatient admission.
Secondary	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).	6 times over approximately 2.5 week inpatient admission.
Secondary	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.	6 times over approximately 2.5 week inpatient admission.
Secondary	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.	6 times over approximately 2.5 week inpatient admission.
Secondary	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.	Daily over approximately 2.5 week inpatient admission.