Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation

NCT ID: NCT01406223

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-06-30

Brief Summary

The purpose of this study is to look at brain function in order to understand how different treatments work to help people quit smoking. In this study, the investigators will look at the effects of nicotine patches, Chantix alone or Chantix paired with Zyban.

Conditions

Nicotine Dependence

Keywords

Nicotine addiction; Cigarette smoking; Smoking cessation; Zyban; Chantix; Nicotine patches; varenicline; bupropion; fMRI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

varenicline

For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

Nicotine patches

Intervention Type: DRUG

Placebo bupropion

Intervention Type: OTHER

Placebo patch

Intervention Type: OTHER

NRT (nicotine patches only)

21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.

Group Type: ACTIVE_COMPARATOR

Nicotine patches

Intervention Type: DRUG

Placebo varenicline

Intervention Type: OTHER

Placebo bupropion

Intervention Type: OTHER

varenicline + bupropion

For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

Bupropion

Intervention Type: DRUG

Nicotine patches

Intervention Type: DRUG

Placebo patch

Intervention Type: OTHER

Post-quit NRT

Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.

Group Type: PLACEBO_COMPARATOR

Nicotine patches

Intervention Type: DRUG

Placebo varenicline

Intervention Type: OTHER

Placebo bupropion

Intervention Type: OTHER

Placebo patch

Intervention Type: OTHER

Interventions

Varenicline

Intervention Type: DRUG

Bupropion

Intervention Type: DRUG

Nicotine patches

Intervention Type: DRUG

Placebo varenicline

Intervention Type: OTHER

Placebo bupropion

Intervention Type: OTHER

Placebo patch

Intervention Type: OTHER

Other Intervention Names

Chantix; Zyban; Nicoderm

Eligibility Criteria

Inclusion Criteria

• Are generally healthy;
• Are 18-50 years old;
• Smoke an average of at least 10 cigarettes per day for at least three cumulative years;
• Have an afternoon expired air carbon monoxide (CO) reading of at least 10ppm;
• Are right-handed as measured by a two-item scale used in our laboratory;
• Express a desire to quit smoking in the next thirty days.
• Potential subjects must agree to use acceptable contraception during their participation in this study.

Potential subjects must agree to avoid the following during their participation in this study:

• participation in any other nicotine-related modification strategy outside of this protocol;
• use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
• use of experimental (investigational) drugs or devices;
• use of illegal drugs;
• use of opiate medications.

Exclusion Criteria

• Inability to attend all required experimental sessions;
• Presence of conditions that would make MRI unsafe (e.g. pacemaker);
• Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
• Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).
• Coronary heart disease;
• Lifetime history of heart attack;
• Cardiac rhythm disorder (irregular heart rhythm);
• Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
• Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
• History of skin allergy;
• Active skin disorder (e.g., psoriasis) within the last five years, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
• Liver or kidney disorder (except kidney stones, gallstones);
• Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
• Active ulcers in the past 30 days;
• Lung disorder (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
• Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
• Migraine headaches that occur more frequently than once per week;
• Recent, unexplained fainting spells;
• Problems giving blood samples;
• Diabetes;
• Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
• Other major medical condition;
• Current psychiatric disease (with the exception of anxiety disorders, Obsessive-compulsive disorder (OCD) and Attention deficit hyperactivity disorder (ADHD));
• Bulimia or anorexia;
• Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
• Current depression;
• Pregnant or nursing mothers;
• Alcohol abuse;
• Significant adverse reaction to nicotine patch, bupropion/Wellbutrin/Zyban or Chantix/Varenicline in the past.
• Use (within the past 30 days) of:

• Illegal drugs (or if the urine drug screen is positive);
• Experimental (investigational) drugs;
• Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
• Smokeless tobacco (chewing tobacco, snuff), cigars or pipes;
• Nicotine replacement therapy or any other smoking cessation aid.
• Use (within the past 14 days) of:

• Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

F. Joseph McClernon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Center for Nicotine and Smoking Cessation Research

Durham, North Carolina, United States

Duke Center for Nicotine and Smoking Cessation Research

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

1P50DA027840-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00028331

Identifier Type: -

Identifier Source: org_study_id