Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-68
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Placebo
- Semaglutide 1.0 mg
- Semaglutide 2.0 mg
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov