Status:
COMPLETED
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
James and Esther King Biomedical Research Program
Pfizer
Conditions:
Smoking Cessation
Tobacco Dependence
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 sm...
Detailed 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 ...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
July 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2019
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT02202499
Start Date
July 17 2014
End Date
June 14 2019
Last Update
November 27 2020
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612