Extended Varenicline and Facilitated Extinction in Increasing Smoking Cessation
This trial is active, not recruiting.
|Conditions||smoking cessation, tobacco dependence|
|Treatments||varenicline, counseling and support materials, laboratory assessments|
|Sponsor||H. Lee Moffitt Cancer Center and Research Institute|
|Collaborator||James and Esther King Biomedical Research Program|
|Start date||July 2014|
|End date||December 2015|
|Trial size||86 participants|
|Trial identifier||NCT02202499, MCC-17654|
The purpose of this Pilot feasibility study is to find out the effect of different behavioral treatments along with different duration of a drug called varenicline, on smoking behavior and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that has been shown to help people quit smoking.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Number of Participants with Reduced Smoking Satisfaction
time frame: 15 months
Male or female participants at least 18 years old.
Inclusion Criteria: - ≥18 years of age - Smoke at least 10 cigarettes daily for the past year - Expired-air carbon monoxide (CO) > 8 ppm - Medically eligible to receive varenicline - Score at least a 5 on the Contemplation Ladder (Biener & Abrams 1991), a measure of motivation to quit smoking. Exclusion Criteria: - Are pregnant or lactating - Have renal dysfunction - Have a history of seizures - Are medically at risk in the judgment of the study physician - Have ever used varenicline - Have used other smoking cessation medications within the past three months - Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders) - Have substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview [MINI]; Sheehan et al 2015). - We must limit the number of participants from the same street address to 1.
|Official title||Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial|
|Principal investigator||Thomas Brandon, Ph.D.|
|Description||Following the initial telephone screening, eligible participants will be scheduled for a screening evaluation session. Following the screening evaluation, participants who pass the medical screening and meet all other inclusion criteria will be scheduled for their first assessment and then randomized to receive standard varenicline (SV), extended varenicline (EV), or extended varenicline plus facilitated extinction (EV + FE). The randomization list will be generated by the study statistician. It will be stratified by gender and will employ a variable block randomization that will guarantee that the arms are balanced when a given block is filled.|
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