Varenicline + Nicotine Patch for Quitting Smoking

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Paul Cinciripini

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults aged 18-75 who smoke at least 5 cigarettes daily, want to quit smoking, and can follow instructions in English. They must be the only participant from their household and have a reachable address and phone number. Excluded are those using other tobacco products frequently, enrolled in another cessation program, with uncontrolled hypertension or significant recent disease, certain psychiatric conditions or drug use.

Inclusion Criteria

Provide informed consent and agree to all assessments and study procedures

Able to follow verbal and written instructions in English and complete all aspects of the study

Be the only participant in their household

Exclusion Criteria

I plan to use nicotine substitutes or treatments to quit smoking soon.

I have not had a serious or unstable illness in the last 3 months.

History of hypersensitivity or allergic reaction to Varenicline, NRT, or any component of these formulations

Treatment Details

Interventions

• Counseling Sessions (Behavioral)
• Lab Session (Other)
• Nicotine Patch (Nicotine Replacement Therapy)
• Placebo Patch (Drug)
• Placebo Tablet (Drug)
• Questionnaires (Behavioral)
• Saliva Test (Other)
• Varenicline (Nicotinic Acetylcholine Receptor Partial Agonist)

Trial Overview The study is testing whether varenicline (a medication) or nicotine patches help people with varying emotional and attention levels quit smoking. Participants will undergo saliva tests, counseling sessions, lab sessions, questionnaires and receive either the actual treatments or placebo versions.

Participant Groups

Group I: Varenicline + Placebo Patch Experimental Treatment 6 Interventions

Varenicline dosing follows the recommended 12 week course: 0.5 milligram 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. Participant takes Varenicline 1-10 days after Visit 1. Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day. Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape. Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.

Group II: Nicotine Patch + Placebo Tablet Experimental Treatment 6 Interventions

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. Starting on Day 8, and then every day after that, participant applies 1 nicotine patch. Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.

Nicotine Patch is already approved in Canada, Japan for the following indications:

Approved in Canada as Nicorette for:

• Smoking cessation

Approved in Japan as Nicoderm CQ for:

• Smoking cessation

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

NAL PHARMA

Collaborator

Trials

1

Recruited

200+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University