NCT02202499

Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Cessation
• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Varenicline	All participants will take the following dose of varenicline: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day through week 16 of the study. Arm descriptions show specific details for each group.
OTHER	Counseling and Support Materials	Counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided.
OTHER	Laboratory Assessments	The first laboratory assessment will consist of completion of questionnaires and a cue-reactivity test. The second laboratory assessment will be scheduled for the end of the week before the participant's quit date. It will involve completion of questionnaires and another cue reactivity test. A follow-up session conducted by research staff will occur one month after the target quit date to collect information about each participant's current smoking status, smoking rate, varenicline use, and opinion about the treatment. A second follow-up session will be conducted by telephone and will occur three months after the target quit date, at the end of varenicline use. At the end of the study, participants will be asked to complete a brief survey asking basic information, similar to the questions during the screening period.

Timeline

• Start date: 2014-07-17
• Primary completion: 2015-12-11
• Completion: 2019-06-14
• First posted: 2014-07-29
• Last updated: 2020-11-27
• Results posted: 2019-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study