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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01406223
First received: June 12, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Nicotine Dependence
Drug: Varenicline
Drug: Bupropion
Drug: Nicotine patches
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1000
Study Start Date: July 2011
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varenicline (Chantix) Drug: 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.
Other Name: Chantix
Drug: Nicotine patches

Placebo Group: 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.

Nicotine Replacement Therapy (NRT) Group: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.

Varenicline and varenicline in combination with bupropion groups: 21 mg/24 h for 1 week before the quit date

Other Name: Nicoderm
Active Comparator: NRT (nicotine patches only) Drug: Nicotine patches

Placebo Group: 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.

Nicotine Replacement Therapy (NRT) Group: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.

Varenicline and varenicline in combination with bupropion groups: 21 mg/24 h for 1 week before the quit date

Other Name: Nicoderm
Active Comparator: varenicline (Chantix) w/ bupropion (Zyban) Drug: 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.
Other Name: Chantix
Drug: 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 bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
Other Name: Zyban
Drug: Nicotine patches

Placebo Group: 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.

Nicotine Replacement Therapy (NRT) Group: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.

Varenicline and varenicline in combination with bupropion groups: 21 mg/24 h for 1 week before the quit date

Other Name: Nicoderm
Placebo Comparator: Placebo oral drugs w/ nicotine patches Drug: Nicotine patches

Placebo Group: 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.

Nicotine Replacement Therapy (NRT) Group: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.

Varenicline and varenicline in combination with bupropion groups: 21 mg/24 h for 1 week before the quit date

Other Name: Nicoderm

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406223

Locations
United States, North Carolina
Duke Center for Nicotine and Smoking Cessation Research
Durham, North Carolina, United States, 27705
Duke Center for Nicotine and Smoking Cessation Research
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: F. Joseph McClernon, Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01406223     History of Changes
Other Study ID Numbers: Pro00028331, 1P50DA027840-01A1
Study First Received: June 12, 2011
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Nicotine addiction
Cigarette smoking
Smoking cessation
Zyban
Chantix
Nicotine patches
varenicline
bupropion
fMRI

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits
Nicotine
Nicotine polacrilex
Varenicline
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on April 21, 2014