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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA024388 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Nabi Biopharmaceuticals | INDUSTRY |
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a treated smoker.
In this project we want to understand the degree to which NicVAX administration changes how much nicotine enters the brain in smokers.
The purpose of the present study is to examine the occupancy of brain β2-containing nicotinic acetylcholine receptors (β2-nAChR) by nicotine both at baseline and following administration of a nicotine vaccine. The number of brain β2-nAChR and the amount of nicotine occupancy both before and after vaccination will be measured using the nicotinic agonist [123I]5-IA-85380 ([123I]5-IA) and single photon emission computed tomography (SPECT). [123I]5-IA will be administered using the bolus plus constant infusion paradigm to smokers abstinent for 4-9 days (time period necessary for nicotine and pharmacological active metabolites to clear from brain). Three baseline SPECT images will be obtained after equilibrium has been reached (~6 hours into the [123I]5-IA infusion). Then, IV nicotine will be administered (0.5-1.5 mg/70 kg will be infused over 10 minutes). Following a series of 4 nicotine vaccine shots, the same procedure will be repeated for a second [123I]5-IA scan day. We hypothesize that occupancy of β2-nAChR will be significantly lower, and take longer to plateau, following nicotine vaccine administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Smoker | Experimental | There is only one arm to the study. All subjects will receive NicVax, [123I]5-I-A-85380,and Nicotine bitartrate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NicVAX | Biological | 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean of the Average Nicotine Binding % at Scan 1 and Scan 2 | nAchR levels from baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irina Esterlis, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Association Connecticut Hospital System | West Haven | Connecticut | 06516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23429725 | Derived | Esterlis I, Hannestad JO, Perkins E, Bois F, D'Souza DC, Tyndale RF, Seibyl JP, Hatsukami DM, Cosgrove KP, O'Malley SS. Effect of a nicotine vaccine on nicotine binding to beta2*-nicotinic acetylcholine receptors in vivo in human tobacco smokers. Am J Psychiatry. 2013 Apr;170(4):399-407. doi: 10.1176/appi.ajp.2012.12060793. |
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Several possible subject were not enrolled in to the study because of the exclusion/inclusion criteria, such as allergies to medications, high blood pressure, or SCID II diagnosis
Enrollment in to the study ended in Feb. 2011. Subjects were screened and recruited from the VA West Haven, CT.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Smoker | Healthy smokers with nicotine dependence Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days [123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Smoker | Healthy smokers with nicotine dependence Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days [123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean of the Average Nicotine Binding % at Scan 1 and Scan 2 | nAchR levels from baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3'-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2. | Posted | Mean | Standard Deviation | percentage of average nicotine binding | 3 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Smoker | Healthy smokers with nicotine dependence Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days [123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irina Esterlis, Ph.D. | Yale University | 203-932-5711 | 3109 | irina.esterlis@yale.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C557119 | NicVAX |
| C426745 | 5-iodo-3-(2-azetidinylmethoxy)pyridine |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| [123I]5-IA-85380 | Radiation | up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days |
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| Nicotine bitartrate | Drug | 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| 0 |
| 14 |
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| 14 |
The sponsor has 30 days to approve anything that PI would like to publish and/or present
| D006573 |
| Heterocyclic Compounds, 1-Ring |