Multi-Site Trial of Tirzepatide for Smoking Cessation
2026年7月15日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
300
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90033
- 募集
- Keck School of Medicine, University of Southern California
-
コンタクト：
- Tom Gilmore
- 電話番号：213-962-0698
- メール：thomas.gilmore@usc.edu
-
主任研究者：
- Christian Hendershot, Ph.D.
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- 募集
- University of Colorado Anschutz Medical Campus
-
主任研究者：
- Joseph Schacht, PhD
-
コンタクト：
- Kristen Raymond
- 電話番号：303-724-3196
- メール：kristen.raymond@cuanschutz.edu
-
-
Connecticut
-
New Haven、Connecticut、アメリカ、06510
- 募集
- Yale University School Of Medicine
-
コンタクト：
- Sabrina Coppola
- 電話番号：203-737-2827
- メール：Sabrina.coppola@yale.edu
-
主任研究者：
- Sherry McKee, PhD
-
-
Illinois
-
Chicago、Illinois、アメリカ、60637
- 募集
- University of Chicago Pritzker School of Medicine
-
コンタクト：
- Claire Wellendorf
- 電話番号：773-834-2244
- メール：cwellendorf@bsd.uchicago.edu
-
主任研究者：
- Andrea King, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
|
Participants will receive placebo (saline) injections for Weeks 1-16
|
|
実験的：ティルゼパチド
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
7-day point prevalence abstinence
時間枠：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)
|
Biochemically verified abstinence from cigarette smoking
|
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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cigarettes per day
時間枠：From baseline through 16 weeks of treatment (final assessment at Week 17 visit)
|
From baseline through 16 weeks of treatment (final assessment at Week 17 visit)
|
|
|
Weekly cigarette craving
時間枠：Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
|
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.
|
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Current cigarette craving
時間枠：Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
|
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.
|
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
|
|
Smoking withdrawal
時間枠：Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
|
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.
|
Baseline through 16 weeks of treatment (final assessment at Week 17 visit)
|
|
Body weight
時間枠：Treatment week 1 through treatment week 16 (final assessment at Week 17 visit)
|
Treatment week 1 through treatment week 16 (final assessment at Week 17 visit)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月5日
一次修了 (推定)
2028年3月1日
研究の完了 (推定)
2028年9月1日
試験登録日
最初に提出
2026年5月11日
QC基準を満たした最初の提出物
2026年5月18日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月17日
QC基準を満たした最後の更新が送信されました
2026年7月15日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HS-25-00642
- U01DA064384 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。