Phase 2
Completed N=52
Improving the Efficacy of Anti-Nicotine Immunotherapy
Source: ClinicalTrials.gov NCT01280968 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs — 1; -15; -0.2; 0.1 percentage of change
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs |
1; -15; -0.2; 0.1; -9; -1.1 | — |
| PRIMARY Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs |
1; -15; 0; -0.7; -6; -1.3 | — |
| PRIMARY Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs |
0; 15; -4.4; -2; 0; 3.8 | — |
| PRIMARY Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff |
22.5; 9; 2.4 | — |
Eligibility 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
- 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 38kg/m2;
- History of psychosis or bipolar disorder;
- Prior exposure to CTY002- NicQ or any other nicotine vaccine.
Data sourced from ClinicalTrials.gov (NCT01280968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.