Multi-Site Trial of Tirzepatide for Smoking Cessation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of Southern California
About this trial
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. Participants will attend weekly clinic visits to receive subcutaneous tirzepatide or placebo over 16 weeks (Visit Weeks 1-16), followed by follow-up visits at Week 17 and Week 27. Medication will be prescribed according to the standard dose titration schedule for the first 16 weeks of treatment (initial dose: 2.5mg/week; final dose: 10mg/week). All participants will also receive nicotine patches.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 without psychotic features), or current secondary psychosis due to substance use or another medical condition
Trial design
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugParticipants will receive tirzepatide (subcutaneous injection) at doses of 2.5mg for Weeks 1-4, 5mg for Weeks 5-8, 7.5mg for Weeks 9-12, and 10mg for Weeks 13-16
Placebo
Other interventionParticipants will receive placebo (saline) injections for Weeks 1-16
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: TirzepatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
7-day point prevalence abstinence
Biochemically verified abstinence from cigarette smoking
Time frame
From baseline through 16 weeks of treatment (final assessment at Week 17 visit) and at 6 months after the target quit date (assessed at Week 27 visit)Secondary outcomes
1
Cigarettes per day
Time frame
From baseline through 16 weeks of treatment (final assessment at Week 17 visit)2
Weekly cigarette craving
Cigarette craving in the past week will be measured using the craving scale of the Wisconsin Smoking Withdrawal Scale, containing 4 items, each scored on a scale of 1-4. Items are summed to generate a score.
Time frame
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)Other outcomes
1
Current cigarette craving
Current cigarette craving will be measured with the Questionnaire on Smoking Urges-Brief, a 10-item scale with items, each scored on a 1-7 scale. Items are summed to generate a total score.
Time frame
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)2
Smoking withdrawal
Withdrawal symptoms are measured with the Wisconsin Smoking Withdrawal Scale (WSWS). The WSWS includes 28 items, each rated on a scale of 0-4. Items are summed to calculate the scale scores.
Time frame
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)3
Body weight
Time frame
Treatment week 1 through treatment week 16 (final assessment at Week 17 visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern California
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov