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Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes

ConditionsAlcohol Use Disorder (AUD)Obesity (BMI Equal to or >30)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Other intervention

    Placebo - administered one weekly for 20 weeks

  • Semaglutide 1.0 mg

    Drug

    Semaglutide 1.0 mg low dose

  • Semaglutide 2.0 mg

    Drug

    Semaglutide 2.0 mg high dose

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Semaglutide 1.0 mgActive comparator 1 intervention
Group C: Semaglutide 2.0 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Alcohol use days

Days of alcohol use over 20 weeks of treatment

Time frame
20 weeks

Secondary outcomes

1

Heavy drinking days

Days of heavy drinkings (Mne: greater than 5 or more drinks; Women: greater than 4 or more drinks)

Time frame
20 weeks
2

Average drinks per drinking day

Average number of alcoholic drinks consumed on a drinking day

Time frame
20 weeks
3

Obsessive Compulsive Drinking Scale (OCDS) to assess Alcohol craving

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.

Time frame
20 weeks

Other outcomes

1

Food Craving Inventory (FCI) to assess Food craving

The FCI is a 28-item self-report questionnaire assessing the frequency of cravings for specific foods over the past month using a 5-point Likert scale (1 = never to 5 = always/almost every day). Total scores range from 28 to 140, with higher scores reflecting more frequent overall cravings.

Time frame
20 weeks
2

Mean change Body weight

Mean changes in body weight (pounds)

Time frame
20 weeks

Sponsors and contacts

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

Yale University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: