Efficacy & Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking

Status Completed

Clinical Trial Summary

Research Aims The aims of this research study are to determine whether cost-free smoking cessation pharmacotherapy: 1. Helps smokers with Transient Ischemic Attack (TIA) or stroke to quit smoking over the long-term, compared to simply providing a prescription for these medications; 2. Is a more cost-effective alternative to providing a prescription only for these medications in this high risk population. Hypotheses to be Tested The hypotheses to be tested include the following: 1. The CO-validated continuous abstinence rate at weeks 26 and 52 following a target quit date will be at least 10% higher for the cost-free smoking cessation pharmacotherapy intervention group compared to the prescription only usual care group; 2. Cost-free smoking cessation pharmacotherapy will have a greater cost-effectiveness (i.e., cost/quit) than providing a prescription only.

Clinical Trial Description

Smokers with Transient Ischemic Attack (TIA) or stroke attending a Stroke Prevention Clinic and willing to quit smoking will be randomly assigned (1:1) to either a prescription only (PO) usual care group or a cost-free (CF) pharmacotherapy experimental group. Participants assigned to the prescription only usual care group will be asked to have their prescription for smoking cessation pharmacotherapy filled at their own cost at their local community pharmacy. Participants assigned to the cost-free pharmacotherapy group will be provided with a 12-week supply of NRT, or a 12-week supply of bupropion or varenicline. The pharmacotherapy will be provided by the research nurse to the patient immediately. All participants will receive identical advice regarding smoking from the attending neurologist, nurse counseling for smoking cessation, and follow-up tracking and telephone-based support for up to 26 weeks after the target quit date. Non-treatment follow-up will continue to week 52 after the target quit date. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00962988
Study type	Interventional
Source	Ottawa Heart Institute Research Corporation
Contact
Status	Completed
Phase	Phase 4
Start date	December 2009
Completion date	April 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03999411` - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients	Phase 4
Completed	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Completed	`NCT04617444` - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function	N/A
Completed	`NCT02796391` - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes	Phase 2
Completed	`NCT03397511` - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City	N/A
Not yet recruiting	`NCT05188287` - A Culturally Tailored Smartphone Application for African American Smokers	N/A
Recruiting	`NCT05264428` - The Effect of Honey on Lessening the Withdrawal Symptoms	N/A
Recruiting	`NCT05846841` - Personalized Tobacco Treatment in Primary Care (MOTIVATE)	N/A
Completed	`NCT04133064` - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study	N/A
Completed	`NCT03187730` - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants	Phase 4
Completed	`NCT03474783` - To Explore the Factors Affecting the Effectiveness of Smoking Cessation	N/A
Completed	`NCT04635358` - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center	N/A
Terminated	`NCT03670264` - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation	N/A
Not yet recruiting	`NCT06307496` - VIDeOS for Smoking Cessation	N/A
Completed	`NCT02997657` - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial	N/A
Completed	`NCT02905656` - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit	N/A
Completed	`NCT03206619` - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed	`NCT02239770` - Pharmacokinetics of Nicotine Film in Smokers	N/A
Completed	`NCT02562521` - A Smoking Cessation Intervention for Yale Dining Employees	Phase 4
Recruiting	`NCT02422914` - Benefits of Tobacco Free Cigarette	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms