Reward Sensitivity and Pharmacotherapy for Smoking Cessation

Summary

The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.

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.

Sponsors & Collaborators

• NAL PHARMA

  collaborator OTHER

• Pfizer

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Jason D Robinson, PHD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-12-14

Primary Completion

2028-02-28

Completion

2028-02-28

FDA Drug

Yes

Countries

• United States

Study Locations