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Benefit and Safety of Cytisinicline (cytisine) for Cessation of Nicotine E-cigarette UseAward last edited on: 2/17/2024
Sponsored Program
STTRAwarding Agency
NIH : NIDATotal Award Amount
$2,817,896Award Phase
2Solicitation Topic Code
279Principal Investigator
Cindy JacobsCompany Information
Phase I
Contract Number: 1R42DA054784-01Start Date: 8/1/2021 Completed: 7/31/2022
Phase I year
2021Phase I Amount
$320,000Public Health Relevance Statement:
NARRATIVE Nicotine is highly addictive, and new electronic nicotine-delivery devices (e-cigarettes) have become popular but have uncertain long-term health impacts including potential cardiovascular and pulmonary disease risks and pulmonary inflammation. Effective pharmacotherapies for nicotine vaping cessation are a priority for public health. Cytisine is a natural compound that has been successfully used in Central and Eastern Europe as a smoking cessation aid for several decades, and in this project Achieve Life Sciences has proposed a pilot clinical study to test the benefit of a newly revised cytisine treatment regimen as a nicotine e-cigarette (vaping) cessation aid.
Project Terms:
Adult; 21+ years old; Adult Human; adulthood; Biological Sciences; Biologic Sciences; Bioscience; Life Sciences; Brain; Brain Nervous System; Encephalon; Budgets; Carbon Monoxide; Cardiovascular Diseases; cardiovascular disorder; Clinical Protocols; Clinical Research; Clinical Study; Clinical Trials; Consent Forms; Consent Documents; Informed Consent Documents; Informed Consent Forms; Cotinine; Scotine; Counseling; Data Collection; Statistical Data Interpretation; Statistical Data Analyses; Statistical Data Analysis; statistical analysis; Double-Blind Method; Double-Blind Study; Double-Blinded; Double-Masked Method; Double-Masked Study; Pharmacotherapy; Drug Therapy; drug treatment; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Europe; Eastern Europe; Health; Immune system; allergic/immunologic body system; allergic/immunologic organ system; Laboratories; Lung diseases; Pulmonary Diseases; Pulmonary Disorder; Respiratory Disease; Respiratory System Disease; Respiratory System Disorder; disease of the lung; disorder of the lung; lung disorder; Nicotine; Nicotine Dependence; nicotine addiction; nicotine dependent; Nicotine Withdrawal; Pamphlets; Booklets; Brochures; Pilot Projects; pilot study; Placebos; Sham Treatment; sham therapy; Probability; Professional Organizations; professional association; professional membership; professional society; Program Development; Public Health; Questionnaires; Relapse; Research Design; Study Type; study design; Research Personnel; Investigators; Researchers; Safety; Saliva; Ships; Smoking; Testing; Time; Treatment Protocols; Treatment Regimen; Treatment Schedule; Vendor; cytisine; citizine; cystisin; cytiton; Accountability; Measures; smoking cessation; cease smoking; quit smoking; stop smoking; Schedule; Withdrawal Symptom; Label; Procedures; Site; Clinical; Phase; Biochemical; Medical; Safety Management; Individual; Databases; Data Bases; data base; Licensing; Logistics; Measurement; uptake; Agonist; Contracting Opportunities; Contracts; Cigarette Smoker; programs; Severities; Salivary; Protocol; Protocols documentation; Treatment Period; treatment days; treatment duration; System; Visit; data management; success; Agreement; Self-Report; Patient Self-Report; disease risk; disorder risk; Devices; Intervention Strategies; interventional strategy; Intervention; Molecular Interaction; Binding; Patient Compliance; patient adherence; patient cooperation; therapy compliance; therapy cooperation; treatment compliance; compliance behavior; Dose; High Prevalence; randomisation; randomization; randomly assigned; Randomized; Subgroup; Case Report Form; Enrollment; enroll; Smoking History; pack years; Monitor; Characteristics; Development; developmental; Behavioral; next generation; efficacy evaluation; efficacy analysis; efficacy assessment; efficacy examination; evaluate efficacy; examine efficacy; clinical research site; clinical site; Outcome; 18 year old; 18 years of age; age 18 years; eighteen year old; eighteen years of age; Abstinence; treatment effect; demographics; commercialization; FDA approved; group intervention; Biological Markers; bio-markers; biologic marker; biomarker; smoking relapse; public health priorities; arm; Institutional Review Boards; IRB; IRBs; Adolescent and Young Adult; Electronic cigarette; e-cig; e-cigarette; ecig; ecigarette; Pulmonary Inflammation; Pneumonitis; vaping; Electronic Nicotine Delivery Systems; Electronic Nicotine Delivery Product; electronic nicotine delivery device; electronic nicotine distribution system; clinical development; nicotine use; nicotine consumption; electronic cigarette user; e-cig user; e-cigarette user; ecig user; ecigarette user; vaper; nicotine exposure; exposure to nicotine; electronic cigarette use; e-cig use; e-cigarette use; ecig use; ecigarette use; nicotine cessation; Lung infections; pulmonary infections; Infrastructure; side effect; e-cigarette cessation; e-cig cessation; ecig cessation; quitting e-cigarettes; quitting e-cigs; quitting ecigarettes; quitting ecigs; vaping nicotine; efficacy outcomes; nicotine reward
Phase II
Contract Number: 4R44DA054784-02Start Date: 8/1/2021 Completed: 2/29/2024
Phase II year
2022(last award dollars: 2023)
Phase II Amount
$2,497,896Public Health Relevance Statement:
NARRATIVE Nicotine is highly addictive, and new electronic nicotine-delivery devices (e-cigarettes) have become popular but have uncertain long-term health impacts including potential cardiovascular and pulmonary disease risks and pulmonary inflammation. Effective pharmacotherapies for nicotine vaping cessation are a priority for public health. Cytisine is a natural compound that has been successfully used in Central and Eastern Europe as a smoking cessation aid for several decades, and in this project Achieve Life Sciences has proposed a pilot clinical study to test the benefit of a newly revised cytisine treatment regimen as a nicotine e-cigarette (vaping) cessation aid.
Project Terms:
Adult; 21+ years old; Adult Human; adulthood; Biological Sciences; Biologic Sciences; Bioscience; Life Sciences; Brain; Brain Nervous System; Encephalon; Budgets; Carbon Monoxide; Cardiovascular Diseases; cardiovascular disorder; Clinical Protocols; Clinical Research; Clinical Study; Clinical Trials; Consent Forms; Consent Documents; Informed Consent Documents; Informed Consent Forms; Cotinine; Scotine; Counseling; Data Collection; Statistical Data Interpretation; Statistical Data Analyses; Statistical Data Analysis; statistical analysis; Double-Blind Method; Double-Blind Study; Double-Blinded; Double-Masked Method; Double-Masked Study; Pharmacotherapy; Drug Therapy; drug treatment; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Europe; Eastern Europe; Health; Immune system; allergic/immunologic body system; allergic/immunologic organ system; Laboratories; Lung diseases; Pulmonary Diseases; Pulmonary Disorder; disease of the lung; disorder of the lung; lung disorder; Nicotine; nicotine addiction; nicotine dependent; Nicotine Dependence; Nicotine Withdrawal; Booklets; Brochures; Pamphlets; pilot study; Pilot Projects; Sham Treatment; sham therapy; Placebos; Probability; professional association; professional membership; professional society; Professional Organizations; Program Development; Public Health; Questionnaires; Relapse; Study Type; study design; Research Design; Investigators; Researchers; Research Personnel; Safety; Saliva; Ships; Smoking; Testing; Time; Treatment Protocols; Treatment Regimen; Treatment Schedule; Vendor; cytisine; citizine; cystisin; cytiton; Accountability; Measures; smoking cessation; cease smoking; quit smoking; stop smoking; Schedule; Withdrawal Symptom; Label; Procedures; Site; Clinical; Phase; Biochemical; Medical; Safety Management; Individual; Data Bases; data base; Databases; Licensing; Logistics; Measurement; uptake; Agonist; Contracting Opportunities; Contracts; Cigarette Smoker; programs; Severities; Salivary; Protocol; Protocols documentation; Treatment Period; treatment days; treatment duration; System; Visit; data management; success; Agreement; Self-Report; Patient Self-Report; disease risk; disorder risk; Devices; Intervention Strategies; interventional strategy; Intervention; Molecular Interaction; Binding; Patient Compliance; patient adherence; patient cooperation; therapy compliance; therapy cooperation; treatment compliance; compliance behavior; Dose; High Prevalence; randomisation; randomization; randomly assigned; Randomized; Subgroup; Case Report Form; Enrollment; enroll; Smoking History; pack years; Monitor; Characteristics; Development; developmental; Behavioral; Placebo Control; placebo controlled; next generation; efficacy evaluation; efficacy analysis; efficacy assessment; efficacy examination; evaluate efficacy; examine efficacy; clinical research site; clinical site; Outcome; 18 year old; 18 years of age; age 18 years; eighteen year old; eighteen years of age; Abstinence; treatment effect; demographics; commercialization; FDA approved; group intervention; Biological Markers; bio-markers; biologic marker; biomarker; smoking relapse; public health priorities; arm; Institutional Review Boards; IRB; IRBs; Adolescent and Young Adult; Electronic cigarette; e-cig; e-cigarette; ecig; ecigarette; Pulmonary Inflammation; Lung Inflammation; Pneumonitis; vaping; Electronic Nicotine Delivery Systems; Electronic Nicotine Delivery Product; electronic nicotine delivery device; electronic nicotine distribution system; clinical development; nicotine use; nicotine consumption; electronic cigarette user; e-cig user; e-cigarette user; ecig user; ecigarette user; vaper; nicotine exposure; exposure to nicotine; electronic cigarette use; e-cig use; e-cigarette use; ecig use; ecigarette use; nicotine cessation; Lung infections; pulmonary infections; Infrastructure; side effect; e-cigarette cessation; e-cig cessation; ecig cessation; quitting e-cigarettes; quitting e-cigs; quitting ecigarettes; quitting ecigs; vaping nicotine; efficacy outcomes; nicotine reward