Multi-Site Trial of Tirzepatide for Smoking Cessation
2026년 7월 15일 업데이트: University of Southern California
A Multi-Site Trial of Tirzepatide for Smoking Cessation
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.
연구 개요
연구 유형
중재적
등록 (추정된)
300
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Los Angeles, California, 미국, 90033
- 모병
- Keck School of Medicine, University of Southern California
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연락하다:
- Tom Gilmore
- 전화번호: 213-962-0698
- 이메일: thomas.gilmore@usc.edu
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수석 연구원:
- Christian Hendershot, Ph.D.
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Colorado
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Aurora, Colorado, 미국, 80045
- 모병
- University of Colorado Anschutz Medical Campus
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수석 연구원:
- Joseph Schacht, PhD
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연락하다:
- Kristen Raymond
- 전화번호: 303-724-3196
- 이메일: kristen.raymond@cuanschutz.edu
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Connecticut
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New Haven, Connecticut, 미국, 06510
- 모병
- Yale University School Of Medicine
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연락하다:
- Sabrina Coppola
- 전화번호: 203-737-2827
- 이메일: Sabrina.coppola@yale.edu
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수석 연구원:
- Sherry McKee, PhD
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Illinois
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Chicago, Illinois, 미국, 60637
- 모병
- University of Chicago Pritzker School of Medicine
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연락하다:
- Claire Wellendorf
- 전화번호: 773-834-2244
- 이메일: cwellendorf@bsd.uchicago.edu
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수석 연구원:
- Andrea King, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion 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
Exclusion Criteria:
- 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
- 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 prescribed an opioid replacement therapy medication and can provide documentation.
- 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 medications (e.g., topiramate) in the past 90 days
- Any health condition or treatment/medication that would preclude use of tirzepatide or NRT, in the opinion of the site physicians including thyroid enlargement.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 위약
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Participants will receive placebo (saline) injections for Weeks 1-16
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실험적: 티르제파티드
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Participants 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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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7-day point prevalence abstinence
기간: 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)
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Biochemically verified abstinence from cigarette smoking
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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)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cigarettes per day
기간: From baseline through 16 weeks of treatment (final assessment at Week 17 visit)
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From baseline through 16 weeks of treatment (final assessment at Week 17 visit)
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Weekly cigarette craving
기간: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
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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.
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Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Current cigarette craving
기간: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
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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.
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Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
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Smoking withdrawal
기간: Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
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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.
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Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
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Body weight
기간: Treatment week 1 through treatment week 16 (final assessment at Week 17 visit)
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Treatment week 1 through treatment week 16 (final assessment at Week 17 visit)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 5일
기본 완료 (추정된)
2028년 3월 1일
연구 완료 (추정된)
2028년 9월 1일
연구 등록 날짜
최초 제출
2026년 5월 11일
QC 기준을 충족하는 최초 제출
2026년 5월 18일
처음 게시됨 (실제)
2026년 5월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 15일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HS-25-00642
- U01DA064384 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 공유 기간
The protocol and SAP will be made available at or before the completion of the study.
Requests for IPD will be reviewed following publication of primary study results.
IPD 공유 액세스 기준
Data will be made available to researchers whose proposed purpose for accessing the data has been approved, and provided a data sharing agreement is in place.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .