Nicotine DependencePhase 2PETNic002NCT01280968
Improving the Efficacy of Anti-Nicotine Immunotherapy
A Phase 2 study testing NIC002 in Aluminum hydroxide (Alum) in people with Nicotine Dependence, run by Alexey Mukhin at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- NIC002 in Aluminum hydroxide (Alum)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to Apr 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
- 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);
Show all 38Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Center for Nicotine & Smoking Cessation Research
Durham, North Carolina, 27705
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
- Conditions
- Nicotine Dependence
- Being tested
- NIC002 in Aluminum hydroxide (Alum), Placebo Vaccine - Aluminum hydroxide
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIC002 in Aluminum hydroxide (Alum)Biological
Also called CYT002-NicQb (Nicotine-Qbeta), Anti-Nicotine Vaccine
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.
Placebo Vaccine - Aluminum hydroxideBiological
Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.
| Study group | Role | What they receive |
|---|---|---|
| NIC002 Vaccine in Aluminum hydroxide | Experimental | 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. Receives: Biological: NIC002 in Aluminum hydroxide (Alum) |
| Placebo Vaccine - Aluminum hydroxide | Placebo comparator | 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. Receives: Biological: Placebo Vaccine - Aluminum hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs
There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
Measured: measured at week 1 and week 16
Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs
There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
Measured: measured at week 1 and week 16
Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs
There was a 2 hour washout period between the "single puff" and "multiple puffs" assessments.
Measured: measured at week 1 and week 16
Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff
Measured: measured at week 1 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexey Mukhin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexey Mukhin, Duke University
- Investigators
- Alexey G Mukhin, M.D., Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280968
- Sponsor's protocol ID
- Pro00019787
- Acronym
- PETNic002
- Status last verified
- Jan 2014
- First submitted
- 16 Nov 2010
- Last updated
- 5 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Efficacy of Anti-Nicotine Immunotherapy
- ClinicalTrials.gov ID
- NCT01280968
- Acronym / sponsor ID
- PETNic002 / Pro00019787
- Conditions
- Nicotine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Alexey MukhinUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, Novartis Pharmaceuticals
- Study start
- Dec 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Posted 18 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIC002 Vaccine in Aluminum hydroxide | Experimental | Biological: NIC002 in Aluminum hydroxide (Alum)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. |
| Placebo Vaccine - Aluminum hydroxide | Placebo comparator | Biological: Placebo Vaccine - Aluminum hydroxide4 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (38 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIC002 in Aluminum hydroxide (Alum)Also: CYT002-NicQb (Nicotine-Qbeta), Anti-Nicotine VaccineFifty-five subjects will receive 4 subcutaneous injections of 0.1 mg Nicotine-QB (NIC002) in Alum vaccine with a 4-week interval between injections. | Biological | NIC002 Vaccine in Aluminum hydroxide |
| Placebo Vaccine - Aluminum hydroxideTen subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections. | Biological | Placebo Vaccine - Aluminum hydroxide |
Primary outcome
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Nicotine Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey G Mukhin, M.D., Ph.D. principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NIC002 in Aluminum hydroxide (Alum) in people with Nicotine Dependence, run by Alexey Mukhin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.