RECRUITING

Suvorexant and Alcohol

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Influence of Orexin Antagonism on Motivation for Alcohol

Quick Facts

Study Start:2024-06-07

Study Completion:2027-03-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06326684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

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.

Contacts and Locations

Study Contact

William W Stoops, PhD

CONTACT

8592575388

william.stoops@uky.edu

Principal Investigator

William W Stoops, PhD

PRINCIPAL_INVESTIGATOR

University of Kentucky

Study Locations (Sites)

Psychopharmacology of Addiction Laboratory

Lexington, Kentucky, 40507

United States

Collaborators and Investigators

Sponsor: University of Kentucky

William W Stoops, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-07

Study Completion Date2027-03-15

Study Record Updates

Study Start Date2024-06-07

Study Completion Date2027-03-15

Terms related to this study

Additional Relevant MeSH Terms

Alcohol Use Disorder