Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation (ConNicBrain)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01406223
First received: June 12, 2011
Last updated: August 8, 2016
Last verified: August 2016

June 12, 2011
August 8, 2016
July 2011
December 2013   (final data collection date for primary outcome measure)
The amygdala and ventral anterior cingulate gyrus (vACG) scans will be compared to evaluate significant differences [ Time Frame: change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) images collected during a cue-reactivity task following 2 weeks of pre-quit treatment ] [ Designated as safety issue: No ]
The amygdala and ventral anterior cingulate gyrus (vACG) scans will be compared to evaluate significant differences [ Time Frame: change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive fMRI images collected during a cue-reactivity task following 2 weeks of pre-quit treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01406223 on ClinicalTrials.gov Archive Site
Days to First Cigarette Following Quitting Smoking [ Time Frame: 11 weeks post quit day and 6 months post quit day. ] [ Designated as safety issue: No ]
Days to first cigarette (i.e. lapse) will be measured via self-report. Correlations between pre- and post-quit brain imaging measures and days to lapse will be examined to assess whether brain function can predict cessation outcomes.
Same as current
Not Provided
Not Provided
 
Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation
Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Nicotine Dependence
  • Drug: Varenicline
    Other Name: Chantix
  • Drug: Bupropion
    Other Name: Zyban
  • Drug: Nicotine patches
    Other Name: Nicoderm
  • Other: Placebo varenicline
  • Other: Placebo bupropion
  • Other: Placebo patch
  • Active Comparator: 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.
    Interventions:
    • Drug: Varenicline
    • Drug: Nicotine patches
    • Other: Placebo bupropion
    • Other: Placebo patch
  • Active Comparator: 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.
    Interventions:
    • Drug: Nicotine patches
    • Other: Placebo varenicline
    • Other: Placebo bupropion
  • Active Comparator: 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.
    Interventions:
    • Drug: Varenicline
    • Drug: Bupropion
    • Drug: Nicotine patches
    • Other: Placebo patch
  • Placebo Comparator: 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.
    Interventions:
    • Drug: Nicotine patches
    • Other: Placebo varenicline
    • Other: Placebo bupropion
    • Other: Placebo patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
282
June 2014
December 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01406223
Pro00028331, 1P50DA027840-01A1
Yes
Not Provided
Not Provided
Duke University
Duke University
National Institute on Drug Abuse (NIDA)
Principal Investigator: F. Joseph McClernon, Ph.D. Duke University
Duke University
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP