Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

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.

Conditions

• Smoking Cessation
• Tobacco 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.

Sponsors & Collaborators

• James and Esther King Biomedical Research Program

  collaborator OTHER

• Pfizer

  collaborator INDUSTRY

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Thomas Brandon, Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-07-17

Primary Completion

2015-12-11

Completion

2019-06-14

FDA Drug

Yes

Countries

• United States

Study Locations