Improving the Efficacy of Anti-Nicotine Immunotherapy

Completed · Phase 2 · Has a placebo group

Conditions studied: Nicotine Dependence

In brief

The purpose of this study is to find out how vaccine-induced antibodies change the way the body processes nicotine from cigarettes. These antibodies absorb nicotine and can reduce nicotine levels in the brain. In this way, the vaccination may help to quit smoking. The central hypothesis is that anti-nicotine antibodies change kinetics of brain nicotine accumulation and distribution of nicotine between the brain and other body tissues. This vaccine is investigational which means that it is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) to help people quit smoking.

Key facts

Study ID

NCT01280968

Run by

Alexey Mukhin

People needed

52

Starts

2010-12-01

Expected to finish

2013-04-01

Last updated by the study team

2014-03-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-55 years old
• Smoked an average of at least 10 cigarettes per day for the past year
• Have an expired air Carbon Monoxide (CO) reading of at least 15 ppm
• Express a desire to quit smoking in the next three to four months.
• 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, snuff, and chewing tobacco
• use of experimental (investigational) drugs or devices;
• use of illegal drugs;
• use of psychiatric medications;
• use of opiate medications;
• use of systemic steroids or other immunosuppressive agents.

You may not qualify if…

• 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).
• Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
• Coronary heart disease or other cardiovascular disorder;
• Lifetime history of heart attack;
• Cardiac rhythm disorder (irregular heart rhythm);
• Chest pains (unless history, exam, and Electrocardiogram (ECG) clearly indicate a non-cardiac source);
• Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
• 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 or other neurological disorder (including but not limited to stroke, brain tumor, and seizure disorder);
• Recent, unexplained fainting spells;
• Problems giving blood samples;
• Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
• Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
• Skin disorder;
• Autoimmune disease;
• Human immunodeficiency virus (HIV) or HIV risk behavior;
• Severe allergies;
• Other major medical condition;
• Current psychiatric disease including major depressive episode, panic attack, psychosis, bipolar disorder or eating disorder;
• Pregnant or nursing mothers;
• Use (within the past 30 days) of:

Where it is running

• Duke Center for Nicotine & Smoking Cessation Research — Durham, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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