Reward Sensitivity and Pharmacotherapy for Smoking Cessation

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

December 14, 2015

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Tobacco Use Cessation
Interventions
DRUG

Varenicline

Varenicline Dosing: 0.5 mg/day by mouth for Days 1-3; 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter.

DRUG

Nicotine Patch

Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11 weeks.

DRUG

Placebo Patch

Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day for 11 weeks.

DRUG

Placebo Tablet

Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.

BEHAVIORAL

Questionnaires

Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. Questionnaires should take about 30-45 minutes total to complete. On Days 17, 24, 38, and 73, done over the phone.

BEHAVIORAL

Counseling Sessions

Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. These sessions take about 15 minutes each time.

OTHER

Lab Session

Participant asked to watch slides. During the lab session, brain electrical activity checked with an electroencephalogram (EEG). Participant completes computer tasks, including questionnaires, that will measure emotions and attention level. These tasks should take about 90 minutes to complete. The lab session may last up to 2 hours.

OTHER

Saliva Test

Saliva tested to check cotinine level at baseline, on Days 8 and 17, end of treatment visit, and at 3 months and 6 months after quitting smoking.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

NAL PHARMA

OTHER

collaborator

Pfizer

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER