Alcohol Use Disorder (AUD), Obesity (BMI Equal to or >30)
Conditions
Keywords
Alcohol Use Disorder, alcohol craving, Semaglutide, food craving, alcohol intake
Brief summary
This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.
Detailed description
A randomized, double blind placebo controlled 20 week study of two doses of Semaglutide (SEMA) versus placebo in men and women with AUD and obesity (OB:BMI 30-49.9 kg/m2) will be studied to assess alcohol and food craving and stress in a validated laboratory model as well as examine changes in alcohol intake and related alcohol use outcomes during a 20 week clinical treatment and 8 week post-treatment follow-up phase of the study, in order to test mechanisms by which SEMA may exerts significant effects on alcohol use disorder outcomes.
Interventions
OTHERPlacebo
Placebo - administered one weekly for 20 weeks
Semaglutide 1.0 mg low dose
DRUGSemaglutide 2.0 mg
Semaglutide 2.0 mg high dose
Sponsors
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
No
Inclusion criteria
* Male and females ages 18-60 and BMI in 30-49.9 kg/m2; * regular weekly alcohol use (at least 3X/week) prior to admission; * must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V; * Good health as verified by screening and physical examination; * Able to read English and complete study evaluation; * Able to provide informed written and verbal consent.
Exclusion criteria
* Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine; * Current use of opiates; * Current use of psychiatric medications, including benzodiazepine-based sedatives/anxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), acamprosate, naltrexone, antabuse, baclofen, varenicline; * Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania); * Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c \>6.5% and on current medications for T2D treatment; * Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well as other cerebral, renal, thyroid or cardiac pathology that would preclude study participation; * Current use of any anti-obesity medications; * Prior history of bariatric surgery or current intragastric balloon; * Current participation in structured meal replacement or weight loss program; * Weight loss of \>=10% over the preceding 6 months; * Women who are pregnant, nursing or refuse use of reliable form of birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol use days | 20 weeks | Days of alcohol use over 20 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heavy drinking days | 20 weeks | Days of heavy drinkings (Mne: greater than 5 or more drinks; Women: greater than 4 or more drinks) |
| Average drinks per drinking day | 20 weeks | Average number of alcoholic drinks consumed on a drinking day |
| Obsessive Compulsive Drinking Scale (OCDS) to assess Alcohol craving | 20 weeks | The OCDS is a 14-item self-report tool that measures alcohol craving, obsessive thoughts about drinking, and compulsive drinking behaviors. Total scores and subscale scores range from 0 to 40, with higher scores reflecting more overall craving in each category and total craving. |
Countries
United States
Contacts
CONTACTRAJITA SINHA, PHD
PRINCIPAL_INVESTIGATORRajita Sinha
Yale University
Outcome results
None listed