Health TrialsbyHealthPanel

Suvorexant and Alcohol

ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorWilliam Stoops

About this trial

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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Able to speak and read English.

Not seeking treatment at the time of the study.

Between the ages of 21 and 55 years.

Engaging in at least one binge drinking episode, per the NIAAA definition, in the last 30 days.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Alcohol

    Drug

    The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.

  • Placebo

    Drug

    The effects of placebo will be determined.

  • Suvorexant

    Drug

    The effects of suvorexant dose 1 will be determined.

  • Suvorexant

    Drug

    The effects of suvorexant dose 2 will be determined.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 2 interventions
Group B: Suvorexant Dose 1Experimental treatment 2 interventions
Group C: Suvorexant Dose 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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.
2

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.
3

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.
4

Heart rate

Beats per minute. Measured daily during inpatient admission.

Time frame
Daily over approximately 3 week inpatient admission.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

William Stoops

Lead sponsor

University of Kentucky

Sponsor institution

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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