Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

July 17, 2014

Primary Completion Date

December 11, 2015

Study Completion Date

June 14, 2019

Conditions
Smoking CessationTobacco Dependence
Interventions
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.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

James and Esther King Biomedical Research Program

OTHER

collaborator

Pfizer

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT02202499 - Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence | Biotech Hunter | Biotech Hunter