Improving the Efficacy of Anti-Nicotine Immunotherapy (PETNic002)

This study has been completed.
Sponsor:
Collaborators:
Wake Forest School of Medicine
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Alexey Mukhin, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01280968
First received: November 16, 2010
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Biological: NIC002 in Aluminum hydroxide (Alum)
Biological: Placebo Vaccine - Aluminum hydroxide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Improving the Efficacy of Anti-Nicotine Immunotherapy

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.

  • Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs [ Time Frame: measured at week 1 and week 16 ] [ Designated as safety issue: No ]
    There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.

  • 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 ] [ Designated as safety issue: No ]
    There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.

  • Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff [ Time Frame: measured at week 1 and week 16 ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: December 2010
Study Completion Date: April 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: NIC002 in Aluminum hydroxide (Alum)
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:
  • CYT002-NicQb (Nicotine-Qbeta)
  • Anti-Nicotine Vaccine
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.
Biological: Placebo Vaccine - Aluminum hydroxide
Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  1. 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.
  2. Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).
  3. 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.
  4. Coronary heart disease or other cardiovascular disorder;
  5. Lifetime history of heart attack;
  6. Cardiac rhythm disorder (irregular heart rhythm);
  7. Chest pains (unless history, exam, and Electrocardiogram (ECG) clearly indicate a non-cardiac source);
  8. Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
  9. Liver or kidney disorder (except kidney stones, gallstones);
  10. Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
  11. Active ulcers in the past 30 days;
  12. Lung disorder (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
  13. Brain abnormality or other neurological disorder (including but not limited to stroke, brain tumor, and seizure disorder);
  14. Recent, unexplained fainting spells;
  15. Problems giving blood samples;
  16. Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
  17. Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
  18. Skin disorder;
  19. Autoimmune disease;
  20. Human immunodeficiency virus (HIV) or HIV risk behavior;
  21. Severe allergies;
  22. Other major medical condition;
  23. Current psychiatric disease including major depressive episode, panic attack, psychosis, bipolar disorder or eating disorder;
  24. Pregnant or nursing mothers;
  25. 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.
  26. Alcohol abuse - The AUDIT (Alcohol Use Disorders Identification Test) questionnaire will be used to assess alcohol abuse.
  27. Previous history of negative experiences with "flu" vaccine or any other vaccine.
  28. High chronic exposure to aluminum (occupational or medical);
  29. Pulmonary function test results < 60% of predicted value for FEV1 and FVC;
  30. Body Mass Index > 38kg/m2;
  31. History of psychosis or bipolar disorder;
  32. Prior exposure to CTY002- NicQ or any other nicotine vaccine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280968

Locations
United States, North Carolina
Duke Center for Nicotine & Smoking Cessation Research
Durham, North Carolina, United States, 27705
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Alexey Mukhin
Wake Forest School of Medicine
Novartis Pharmaceuticals
Investigators
Principal Investigator: Alexey G Mukhin, M.D., Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Alexey Mukhin, Professor of Psychiatry and Behavioral Science, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01280968     History of Changes
Other Study ID Numbers: Pro00019787
Study First Received: November 16, 2010
Results First Received: October 29, 2013
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Aluminum Hydroxide
Nicotine
Nicotine polacrilex
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014