BridgeMD
New treatment option for Alcohol Use Disorder
Official title Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking
ClinicalTrials.gov ID: NCT07214207
What this study is testing
What is Suvorexant 10 mg?
Suvorexant 10 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alcohol use disorder.
Also referred to as Belsomra.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are: Is SUV effective for AUD?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Generally medically and neurologically healthy;
- Age 18 to 65 at the time of consent;
- Willing and able to give informed consent;
- Current DSM-5 diagnosis of moderate to severe alcohol use disorder;
- Engages in heavy alcohol use defined as drinking ≥14 standard drinks per week if male, and ≥7 standard drinks per week if female;
You likely can't join if
- Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function, and/or task performance, and/or...
- Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
- Current substance use disorder (SUD) other than alcohol or mild cannabis use disorder;
- Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial (women);
- Any use of medications for alcohol use disorder or any psychotropic medications (e.g., psychostimulants and benzodiazepines, some antidepressants);
- Current antihistamines use or medication use that may increase risk including, prescribed, over-the-counter, and herbal preparations, as determined...
See the full eligibility criteria
- Generally medically and neurologically healthy;
- Age 18 to 65 at the time of consent;
- Willing and able to give informed consent;
- Current DSM-5 diagnosis of moderate to severe alcohol use disorder;
- Engages in heavy alcohol use defined as drinking ≥14 standard drinks per week if male, and ≥7 standard drinks per week if female;
- Self-reported treatment-seeking for alcohol use disorder
- Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function, and/or task performance, and/or interfere with the study protocol, and/or be contraindicated for...
- Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
- Current substance use disorder (SUD) other than alcohol or mild cannabis use disorder;
- Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial (women);
- Any use of medications for alcohol use disorder or any psychotropic medications (e.g., psychostimulants and benzodiazepines, some antidepressants);
- Current antihistamines use or medication use that may increase risk including, prescribed, over-the-counter, and herbal preparations, as determined by the study physician;
- Current use of strong or moderate inhibitors of CYP3A liver enzymes;
- Current use of strong CYP3A inducers;
- Current use of digoxin;
- Liver function tests more than 3 times the upper limit of normal or elevated bilirubin;
- Engages in night shift work;
- Smoke 10 or more cigarettes (or electronic equivalent) per day and are thus susceptible to acute nicotine withdrawal during lab visits;
- Obesity as defined by a body-mass index (BMI) equal or greater than 30, as calculated from weight and height self-report;
- Clinically significant alcohol withdrawal symptoms the day of the lab sessions, defined as a score \>10 on the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar);
- Unwilling/unable to sign the informed consent document;
- Under 18 years old or over 65 years old at the time of enrollment;
- Have attempted suicide in the past 3 years and/or have current suicidal ideation determined as greater than moderate via the Columbia Suicide Severity Rating Scale (C-SSRS)
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.