Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence
NCT02202499
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- ≥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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- London,
- Tampa, Florida
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence | ||||
Official Title ICMJE | Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial | ||||
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 smoking. Varenicline, also known as Chantix?, is an FDA-approved medication that has been shown to help people quit smoking. | ||||
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 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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Early Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | ||||
Condition ICMJE |
| ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE |
| ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 86 | ||||
Original Estimated Enrollment ICMJE | 85 | ||||
Actual Study Completion Date ICMJE | June 14, 2019 | ||||
Actual Primary Completion Date | December 11, 2015 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02202499 | ||||
Other Study ID Numbers ICMJE | MCC-17654 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | H. Lee Moffitt Cancer Center and Research Institute | ||||
Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | ||||
Collaborators ICMJE |
| ||||
Investigators ICMJE |
| ||||
PRS Account | H. Lee Moffitt Cancer Center and Research Institute | ||||
Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |