Clinical trial NCT01406223: Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation
Official title: Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nicotine Dependence
Keywords: Nicotine addiction
Cigarette smoking
Smoking cessation
Zyban
Chantix
Nicotine patches
varenicline
bupropion
fMRI
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-08-01
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences
timeFrame: 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
Secondary outcomes:
measure: Days to First Cigarette Following Quitting Smoking
timeFrame: Up to 11 weeks post quit day.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Nicotine and Smoking Cessation Research
state: North Carolina
city: Raleigh
country: United States
facility: Duke Center for Nicotine and Smoking Cessation Research
state: North Carolina
Study officials:
affiliation: Duke University
name: F. Joseph McClernon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: