Immune System Diseases

All Conditions

Hypersensitivity

All Drugs and Chemicals

Central Nervous System Stimulants

Tin Fluorides

Nicotine

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

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.

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.

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.

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

Nicotine Patch

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

Placebo Patch

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.

Placebo Tablet

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.

Questionnaires

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.

Counseling Sessions

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.

Lab Session

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.

Saliva Test

Paul Cinciripini, PHD, MS, BS

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.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to Group 1 or 2.

* If you are in Group 1, you will receive varenicline and a placebo patch. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
* If you are in Group 2, you will receive an active nicotine patch and a placebo tablet.

Neither you nor the study doctor will know which group you are assigned to. However, if needed for your safety, the study staff will be able to find out what you are receiving (called "unblinding").

Once the study has ended and the Data Safety Monitoring Board (DSMB) at MD Anderson has granted approval, you may be unblinded at your request.

Study Drug Administration:

You will start taking your assigned study drug(s) the day after Visit 1.

You should take varenicline/placebo tablets by mouth with a cup (8 ounces) of water after eating a full meal. On Days 1-3, you will take 1 dose of the study drug each morning. Starting on Day 4, and then every day after that, you will take 1 dose in the morning and 1 dose in the evening (for a total of 2 doses of the study drug each day). You must return any study drug bottles as well as any unused study drug to the study staff at each study visit.

You should apply the nicotine/placebo patch to the upper arm. You should put it in a slightly different place each day to avoid skin irritation. You may take the patch off at night to avoid sleeping problems.

You will be given a study diary to record how many cigarettes you smoke (if any) each day while you are on study.

You must return your study diary and any unused study drugs, patches, and/or containers at each study visit.

Study Visits (Visits 1-7):

At every study visit:

* You will complete questionnaires about several topics, including depression, suicide, your smoking behavior, and any effects from the study drug. These questionnaires should take about 30-45 minutes in total to complete.
* You will be giving the opportunity to complete the questionnaires verbally with a study staff member (either on phone or in person depending on the visit number) or electronically on your computer using a website administered by an online survey development company called Qualtrics.
* You will receive counseling about quitting smoking, where you will talk about possible "triggers" for smoking and strategies for dealing with quitting smoking. These sessions will take about 15 minutes each.

At Visits 1, 4 and 6:

* Urine or saliva will be collected for a routine test to check your cotinine, nicotine, and anabasine levels. Cotinine is a chemical released in your body when it breaks down nicotine and will show whether and how much you have recently smoked. Anabasine is used to show if nicotine is found in the blood due to a nicotine replacement therapy or from tobacco use.
* Your CO level and weight. will be measured.
* If you did not have one during screening, you will have a physical exam.
* If you did not complete at one during screening or before Visit 1, you will complete the EEG/lab session.
* If you can become pregnant, urine will be collected for a pregnancy test.
* At V1, if your CO machine tests results are unclear, and the study staff thinks it is appropriate, a NicAlert test will be performed. Urine will be collected for the NicAlert test, which is more sensitive at detecting levels of smoking than the CO machine.

During counseling on Day 8, you will set a "quit date" for stopping smoking for about 1 week after you start taking the study drug/placebo. You should not quit smoking before the quit date. You may also set goals to reduce smoking. You should try to stay smoke-free after the quit date. You will also be given a drug instruction sheet, a card with emergency contact information, and a participant manual to help you follow along with the topics discussed during counseling.

Visits 2, 3, 5 and 7 will be conducted over the phone. You will complete questionnaires about several topics (either on the phone or electronically), including depression, mood, your smoking behavior, and any effects from the study drug. You will also be asked about any drugs you may be taking. Each call should take about 25-45 minutes.

The study staff will call you 1 day before your quit date and 3 days after your quit date to check on your progress in quitting smoking. Each call should take about 10-15 minutes.

Lab Session:

You will take part in a lab session at or before Visit 1 to test your brain activity. You will be asked to watch slides. The slides will include pictures of people, nature, and artwork. Slides showing nude people, medical procedures, and victims of car crashes will also be shown. You will be shown examples of these slides before beginning the procedure and given the opportunity to withdraw from the study.

During the lab session, your brain electrical activity will be checked with an electroencephalogram (EEG). To do this, small sensors will be placed on your scalp and face. You should not drink more than 2 cups of coffee or other caffeinated drinks for at least 2½ hours before the session. At the lab session, you may be asked to smoke a cigarette if the doctor thinks it is needed for you to show your normal smoking behavior.

You will also complete computer tasks, including questionnaires that will measure your emotions and attention level. These tasks should take about 90 minutes to complete.

The lab session may last up to 2 hours.

Ecological Momentary Assessments (EMA):

EMA are used to gather information about your mood and cravings as they happen in your day-to-day life. At your randomization visit, you will be loaned a smart phone device, and will be asked to complete questionnaires on the device at different times everyday throughout the active treatment phase (12 weeks). In these questionnaires, you will be asked about events from the previous day, such as cigarettes per day, alcohol intake, mood, sleep, motivation, and whether you took your prescribed drugs on time. These questionnaires should take up to about 20 minutes per day to complete.

Length of Treatment:

You will receive the study drug/placebo for up to 12 weeks. You will be taken off study early if the doctor thinks it is in your best interest or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

End-of-Treatment Visit (Visit 8):

After you have finished taking the study drug/placebo, the following tests and procedures will be performed:

* Your CO level will be measured.
* Blood (about 2 teaspoons) will be drawn to check your liver and kidney function.
* Urine or saliva will be collected to measure your nicotine, anabasine, and cotinine level.
* You will complete the same questionnaires you completed at the regular study visits.
* You will receive counseling about quitting smoking.
* If you can become pregnant, urine will be collected for a pregnancy test.

Follow-Up Visits (Visits 9 and 10):

At about 3 and 6 months after you have stopped smoking, the following tests and procedures will be performed:

* Your CO level will be measured.
* Urine or saliva will be collected to measure your nicotine, anabasine, and cotinine level.
* You will complete the same questionnaires you completed at the regular study visits.

This is an investigational study. Varenicline and the nicotine patch are both FDA approved and commercially available to help people stop smoking. The study doctor can explain how the study drugs are designed to work.

Up to 160 participants will be enrolled in this portion of the study. All will take part at MD Anderson.

Reward Sensitivity and Pharmacotherapy for Smoking Cessation

The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity

Continuous abstinence over the last 4 weeks of treatment (i.e. EOT-end of treatment) will serve as the primary outcome measure. Saliva will be collected to measure cotinine level.

For prolonged abstinence, relapse defined by 7 or more consecutive days of smoking or smoking at least 1 cigarette over two consecutive weeks from the end of the grace period to a future time point (e.g., EOT, 3- and 6- months post-quit date).

NAL PHARMA

Pfizer

M.D. Anderson Cancer Center

Nervous System Diseases

Symptoms and General Pathology

Neoplasms

Skin and Connective Tissue Diseases

Neuralgia

Breast Neoplasms

Pain

Mastodynia

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Lidocaine

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Drug: lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.

Drug: placebo patch, 1 patch was applied topically to the affected site(s) for 12 hours each day.

1 patch was applied topically to the affected site(s) for 12 hours each day.

Lidoderm patch

Placebo patch

This trial is part of a larger, longitudinal study of symptoms that occur in the breast surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women who wear the lidocaine patch will report a decrease in pain and decreased interference with function compared to women who wear the placebo patch.

Symptom Management After Breast Cancer Surgery

A Randomized, Double-Blind, Placebo-Controlled Trial (RDBPCT) of the Effectiveness of the Lidocaine Patch in the Management of Neuropathic Pain After Breast Cancer Surgery

Patients scored their pain intensity in the breast and/or ipsilateral arm using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10). The change in pain intensity was calculated from two time points as the later time point (12 weeks) minus the earlier time point (Baseline).

University of California, San Francisco

Lidocaine patch One patch is changed every twenty-four hours

Lidocaine Patch

Placebo patch: Patch is changed every 24 hours

Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.

Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day.

Total

Age, Continuous

Sex: Female, Male

White

Black

Asian/Pacific Islander

Hispanic or Mixed Ethnic Background

Race/Ethnicity, Customized

United States

Region of Enrollment

Patients scored their pain intensity in the breast and/or ipsilateral arm at enrollment using a 0 to 10 numeric rating scale, ranging from no pain (0) to worst pain imaginable (10)

Average pain intensity

Worst pain intensity

Dr. Christine Miaskowski, PI

This study attempted to evaluate changes in average pain intensity following breast cancer surgery. However, since none of the patients in the lidocaine group completed the 12 week trial, the outcomes of this study cannot be evaluated.

Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks

Pain Interference With Function

Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.), 1 patch was applied topically to the affected site(s) for 12 hours each day.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reward Sensitivity and Pharmacotherapy for Smoking Cessation	NCT02162849	Tobacco Use Ces...	Varenicline Nicotine Patch Placebo Patch Placebo Tablet Questionnaires Counseling Sess... Lab Session Saliva Test	18 Years - 75 Years	M.D. Anderson Cancer Center
Symptom Management After Breast Cancer Surgery	NCT00686127	Neuropathic Pai... Postmastectomy ...	Lidoderm patch Placebo patch	18 Years -	University of California, San Francisco
Reward Sensitivity and Pharmacotherapy for Smoking Cessation	NCT02162849	Tobacco Use Ces...	Varenicline Nicotine Patch Placebo Patch Placebo Tablet Questionnaires Counseling Sess... Lab Session Saliva Test	18 Years - 75 Years	M.D. Anderson Cancer Center
Symptom Management After Breast Cancer Surgery	NCT00686127	Neuropathic Pai... Postmastectomy ...	Lidoderm patch Placebo patch	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for placebo patch