- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280968
Improving the Efficacy of Anti-Nicotine Immunotherapy (PETNic002)
January 29, 2014 updated by: Alexey Mukhin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke Center for Nicotine & Smoking Cessation Research
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
- 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);
- Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed)
- Smokeless tobacco (chewing tobacco, snuff), cigars, pipes or e-cigarettes;
- Nicotine replacement therapy or any other smoking cessation aid.
- Alcohol abuse - The AUDIT (Alcohol Use Disorders Identification Test) questionnaire will be used to assess alcohol abuse.
- Previous history of negative experiences with "flu" vaccine or any other vaccine.
- High chronic exposure to aluminum (occupational or medical);
- Pulmonary function test results < 60% of predicted value for FEV1 and FVC;
- Body Mass Index > 38kg/m2;
- History of psychosis or bipolar disorder;
- Prior exposure to CTY002- NicQ or any other nicotine vaccine.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NIC002 Vaccine in Aluminum hydroxide
4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination.
The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
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Fifty-five subjects will receive 4 subcutaneous injections of 0.1 mg Nicotine-QB (NIC002) in Alum vaccine with a 4-week interval between injections.
Other Names:
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Placebo Comparator: Placebo Vaccine - Aluminum hydroxide
4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination.
The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
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Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs
Time Frame: measured at week 1 and week 16
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There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
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measured at week 1 and week 16
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Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs
Time Frame: measured at week 1 and week 16
|
There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
|
measured at week 1 and week 16
|
Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs
Time Frame: measured at week 1 and week 16
|
There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
|
measured at week 1 and week 16
|
Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff
Time Frame: measured at week 1 and week 16
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measured at week 1 and week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexey G Mukhin, M.D., Ph.D., Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
November 16, 2010
First Submitted That Met QC Criteria
January 20, 2011
First Posted (Estimate)
January 21, 2011
Study Record Updates
Last Update Posted (Estimate)
March 5, 2014
Last Update Submitted That Met QC Criteria
January 29, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Immunologic Factors
- Gastrointestinal Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Adjuvants, Immunologic
- Antacids
- Vaccines
- Nicotine
- Aluminum Hydroxide
Other Study ID Numbers
- Pro00019787
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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