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โ† Trials
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Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking Cessation

RecruitingPhase 2Ages 18 Years - anyAllUniversity of Oklahoma
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In plain words

What the trial is, and whether it could suit you

No published studies to date have evaluated the combined impact of varenicline and oral nicotine replacement therapy (NRT) on smoking cessation in a randomized trial. Oral NRT, such as nicotine lozenges, can provide acute relief from cravings/withdrawal, and offers individuals the flexibility to deliver nicotine quickly, in contrast with the continuous, passive, and slow-acting delivery of the nicotine patch. Nevertheless, in clinical trials of other combination pharmacotherapies, participants' adherence to of oral NRT has been suboptimal, making it difficult to determine whether there is an added benefit. Given the near-ubiquity of smartphone ownership (85% of U.S. adults), it is plausible that smartphone-based medication adherence interventions could have a positive influence on pharmacotherapy adherence and smoking cessation. This investigative team has demonstrated the feasibility an

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Able to provide documentation of identity (to prevent fraudulent enrollment) and Oklahoma residence (due to limitations on prescribing to out-of-state residents) * Reports daily smoking โ‰ฅ5 cigarettes per day * Provides a breath CO sample โ‰ฅ6ppm to verify current smoking * Willing to schedule a smoking cessation attempt within the next 1-2 weeks * Willing to abstain from smoking cannabis or other combustible products during the study * Willing to use varenicline and nicotine lozenges * Willing to participate in the study for โ‰ˆ6 months * Able to demonstrate \>6th grade literacy which is necessary to read intervention materials and complete study assessments Exclusion Criteria: * Does not own a smartphone that is compatible with the study app * Using an FDA-approved smoking cessation medication within the past 30 days * Using oral nicotine products (e.g., pouches, chewing tobacco, snus) more than once per week (5+ times) during the past 30 days * History of seizures (varenicline contraindication) * History of allergic reaction to varenicline * Pregnant, planning to become pregnant, or currently breastfeeding * Unwilling or unable to use varenicline or nicotine lozenges for other reasons (e.g., severe dry mouth, past history of severe medication side effects) * Other medical reasons at the discretion of the prescribing physician (e.g., uncontrolled hypertension, recent myocardial infarction) * Weekly or more frequent use of combustible cannabis during the past 30 days with a score โ‰ฅ2 on the Cannabis Use Disorder Identification Test-Short Form
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What it tests

  • Varenicline (VAR)
  • Nicotine lozenge (NRT)
  • Smartphone intervention with adherence components (COMBO-A)
  • Smartphone intervention without adherence components (COMBO-B)
  • Telephone Counseling
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Where

1 site
TSET Health Promotion Research Center
Oklahoma City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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