Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

Completed · Early Phase 1

Conditions studied: Smoking Cessation, Tobacco Dependence

In brief

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.

Key facts

Study ID

NCT02202499

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

86

Starts

2014-07-17

Expected to finish

2019-06-14

Last updated by the study team

2020-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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.

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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