Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation, Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/29/2017 |
| Start Date: | July 17, 2014 |
| End Date: | March 31, 2018 |
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial
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.
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.
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.
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.
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.
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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