BridgeMD
New treatment option for Smoking Cessation
Official title Multi-Site Trial of Tirzepatide for Smoking Cessation
ClinicalTrials.gov ID: NCT07602699
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for smoking cessation.
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
- This multi-site clinical trial will generate data on the efficacy of tirzepatide for smoking cessation and associated outcomes (e.g., post-cessation weight gain) in treatment-seeking people who smoke (PWS) with overweight or obesity. A sample of 300 treatment-seeking people who smoke with body mass index of 25 kg/m2 or greater will be recruited from four geographic sites (University of Southern California, Yale University, University of Chicago, and University of Colorado Anschutz Medical Campus) to participate in a parallel-arm, dose-escalating, placebo-controlled trial.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 16 weeks
- 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 21 to 65
You may be able to join if
- Age 21-65 years
- Body mass index ≥ 25kg/m2 at the baseline screening
- Reporting ≥10 cigarettes per day, on average, for the past 6 months and \> 2 year duration of smoking
- Interest in making a long-term cessation attempt within the next 30-60 days
- Willingness to receive study medication and standard-of-care smoking cessation supports (nicotine replacement therapy and a smoking cessation app)
You likely can't join if
- BMI \< 25 kg/m2 at screening
- History of diabetes, diabetes-attributable medical conditions, or HbA1c ≥6.5% at baseline
- Recent (past 90 days) active suicidal ideation or lifetime history of suicide attempt
- Current treatment for psychotic disorders or mood disorders with psychotic features (e.g., schizophrenia, schizoaffective disorder, depression with...
- Meeting DSM-5 criteria for a current (past 12 months) substance use disorder other than tobacco use disorder, mild or moderate cannabis use disorder...
- Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A...
See the full eligibility criteria
- Age 21-65 years
- Body mass index ≥ 25kg/m2 at the baseline screening
- Reporting ≥10 cigarettes per day, on average, for the past 6 months and \> 2 year duration of smoking
- Interest in making a long-term cessation attempt within the next 30-60 days
- Willingness to receive study medication and standard-of-care smoking cessation supports (nicotine replacement therapy and a smoking cessation app)
- Ability to adhere to weekly visits and study procedures over the study period (i.e., no plans to move or travel for extended periods)
- Exhaled CO of \>5ppm at baseline
- Use of an acceptable birth control method for female participants\
- Ability to read and communicate in English
- BMI \< 25 kg/m2 at screening
- History of diabetes, diabetes-attributable medical conditions, or HbA1c ≥6.5% at baseline
- Recent (past 90 days) active suicidal ideation or lifetime history of suicide attempt
- Current treatment for psychotic disorders or mood disorders with psychotic features (e.g., schizophrenia, schizoaffective disorder, depression with psychotic features), current treatment for bipolar disorder (with or...
- Meeting DSM-5 criteria for a current (past 12 months) substance use disorder other than tobacco use disorder, mild or moderate cannabis use disorder, or mild or moderate alcohol use disorder.
- Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A positive screen for opioids will be allowed if the participant is...
- Past 30-day initiation of psychiatric medications (e.g., SSRIs) or changes to medication dose
- Treatment with tirzepatide or another GLP-1RA medication in the prior 6 months
- Current (past month) treatment with other weight loss, diabetes, or smoking cessation medications (varenicline or bupropion; excluding nicotine replacement products)
- Severe GI disease (e.g., gastroparesis, ulcerative colitis).
- History of gastric bypass surgery or other surgeries of the stomach
- Any health condition or treatment/medication that would preclude the use of tirzepatide or NRT, in the opinion of the study physician, including severe cardiovascular disease
- History of chronic pancreatitis or acute pancreatitis in the last 6 months
- Currently nursing, pregnant, or anticipating pregnancy
- History of diabetic retinopathy, proliferative retinopathy, or maculopathy
- Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (\>5x upper limit of normal range)
- History of malignant neoplasms in the last 5 years, except non-melanoma skin cancer
- Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule)
- Currently enrolled in another clinical study involving an investigational product
- Currently living in the same household as someone taking a GLP-1 medication, or living with a current or former participant in the present trial
- Planned surgical procedures requiring anesthesia during the planned study medication period
- Personal or family history of medullary thyroid cancer
- Personal or family history of multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Treatment with other weight loss (e.g., phentermine), or FDA-approved, non-NRT smoking cessation therapies (varenicline, bupropion) or FDA-approved AUD medications (naltrexone, acamprosate, disulfiram) or off-label AUD...
- Any health condition or treatment/medication that would preclude use of tirzepatide or NRT, in the opinion of the site physicians including thyroid enlargement.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Chicago, Illinois, 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 study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Chicago, Illinois, 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.