Study of Tirzepatide for Recovery and Alcohol Use Management (STREAM)

Mass General Brigham

Status and phase: Not yet enrolling; Phase 2

Conditions: Alcohol Use Disorder (AUD)

Treatments: Other: Saline Placebo; Drug: Tirzepatide

Study type: Interventional

Funder types: Other

Identifiers

NCT06727331

2024P003497

Details and patient eligibility

About

This is a pilot, 4-week, double-blind, placebo-controlled, randomized trial of individuals with alcohol use disorder (AUD) to receive weekly injections of either tirzepatide (n=10) or matching placebo (n=10). The primary aim is to determine the effects of tirzepatide on cue-reactivity among individuals with AUD. The secondary aim is to assess the safety and preliminary efficacy of tirzepatide for AUD.

Full description

Participants include N=20 men and women with DSM5 diagnosis of AUD. Potential participants will be screened and enrolled only if they meet full inclusion criteria. After screening and baseline procedures (Visits 1 and 2) are complete, participants will be randomized to receive either tirzepatide or placebo. Following randomization, participants will be scheduled for five study visits (Visits 3-7). Each visit will last approximately 1 hour, except for study visits 2 and 7 which will take no more than 3 hours in order to conduct additional neurocognitive testing, including cue-induced cravings and decision-making tests. At visits 2-7, participants will complete vital signs, weight, urine toxicology testing, a blood draw for glucose, and questionnaires probing secondary outcomes (i.e. anxiety and depression, suicidality, substance use, opioid withdrawal symptoms, cravings, etc). At study visits 3-6, the weekly dose of tirzepatide or placebo will be administered, and assessment of adverse events will also be completed. Both participants and study staff (including raters) will be blinded to active drug vs. placebo. At visit 2, subjects' expectations about their potential treatment will be queried. The final visit, visit 7, also called the follow-up visit, will also assess subjects' guess as to which treatment they received. The medication will be purchased from the manufacturer and stored by IDS. The IDS will extract the tirzepatide and draw the dose into syringes, which will match visually with the placebo doses.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking adults aged 18 and above
• Admitted to the inpatient withdrawal management at Brigham and Women's Faulkner Hospital (BWF) Addiction Recovery Program (ARP) for the treatment of alcohol withdrawal.
• Diagnosed with current DSM-5 alcohol use disorder
• Willing to travel to BWH CCI outpatient facilities for study visits after discharge from the BWF ARP.

Exclusion criteria

• DSM-5 diagnosis of any current substance use disorder excluding alcohol, cannabis or tobacco
• CIWA score at screening ≥ 8.
• Psychotic disorder, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent
• Any lifetime diagnosis of eating disorders including anorexia, bulimia, binge eating, or avoidant/restrictive food intake disorder
• BMI<25mg/kg2
• Current or lifetime diagnosis of Type 1 or Type 2 diabetes
• Current (or within 30 days of enrollment) use of any medications for AUD (naltrexone, acamprosate, disulfiram, gabapentin, etc.), any anti-obesity medications, or medications with glucose lowering properties (including GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors, or sodium-glucose cotransporter-2 (SGLT-2) inhibitors)
• Use of any GLP-1 agonist medications in the prior 3 months
• Anticipating receipt of any other GLP-1 agonist medications during the trial
• History of wight loss surgery
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
• History of or current hypoglycemia
• Calcitonin ≥ 50 ng/L
• Untreated cholelithiasis or gallbladder disease
• History of or current angina pectoris, coronary heart disease, congestive heart failure, inflammatory bowel disease, chronic obstructive pulmonary disease, bariatric surgery, pancreatitis, diabetic gastroparesis
• Liver function test greater than 5 times upper normal limit
• Renal impairment as indicated by eGFR of <60
• History of hypersensitivity or allergy to tirzepatide
• Pregnant or breastfeeding
• Anticipated to be enrolled in another clinical drug trial during participation in this trial
• Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Tirzepatide

Experimental group

Description:

This arm will receive tirzepatide (n=10) weekly 2.5mg injections for 4 weeks.

Treatment:

Drug: Tirzepatide

Saline Placebo

Placebo Comparator group

Description:

This arm will receive saline placebo injections (n=10) weekly for 4 weeks.

Treatment:

Other: Saline Placebo