Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DA025065 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, we sought to explore brain activity in nicotine-dependent men in response to acute intravenous nicotine using pharmacological magnetic resonance imaging (phMRI).
phMRI was used to evaluate brain activity in response to 1.5 mg/70 kg intravenous nicotine or saline. The nicotine and saline were administered on different visits. The time courses of individual subjects' nicotine levels were used as regressors to assess neural activity relating to the infusions. The influence of Smoking history and physiological measures on the response to nicotine were also investigated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Nicotine (1.5 mg/70 kg) | Active Comparator | Participants are given a siingle infusion of nicotine (1.5 mg/70 kg), administered over 1 minute into the antecubital vein 10 minutes into their MRI scans |
|
| Saline - placebo | Placebo Comparator | Participants are given physiological saline, administered over 1 minute into the antecubital vein 10 minutes into their MRI scans |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Nicotine | Drug | Subjects received a single infusion of nicotine, 1.5 mg/70kg (New England Compounding Center, Framingham, MA), administered over 1 minute into the antecubital vein 10 minutes into their MRI scans. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Nicotine Levels | Peak nicotine level in each participant | 0, 2, 4, 6, 8, 10, 12, 14, 16, 20, 30 minutes post-infusion |
| Number of Brain Regions With a Change in Brain Activity Relative to Saline | PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps. | 40 minutes after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With the Nicotine Time Course Controlling for Smoking History | PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course controlling for smoking history (pack years). The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants with any lifetime DSM-IV Axis I disorder other than nicotine dependence.
Participants with clinically significant medical disorders.
Women who are pregnant as determined by laboratory testing for serum beta hCG.
Women who use hormonal contraceptive medications will not be accepted, because this would confound the hormonal measures.
Women with a mean BMI of outside the range 18.0-27.0 and men with a BMI outside the range 21.4-29.0.
Participants with ferromagnetic implants or other contraindications to fMRI
Participants who describe themselves as seeking treatment will not be selected but will be referred to local smoking cessation programs.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott E. Lukas, PhD | Mclean Hospital | Principal Investigator |
| Harrison G Pope, MD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcohol and Drug Abuse Research Center at McLean Hospital | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23117126 | Result | Yamamoto RT, Rohan ML, Goletiani N, Olson D, Peltier M, Renshaw PF, Mello NK. Nicotine related brain activity: the influence of smoking history and blood nicotine levels, an exploratory study. Drug Alcohol Depend. 2013 Apr 1;129(1-2):137-44. doi: 10.1016/j.drugalcdep.2012.10.002. Epub 2012 Oct 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then Nicotine | Placebo first, then Intravenous Nicotine (1.5 mg/70 kg) |
| FG001 | Nicotine First, Then Placebo | Intravenous Nicotine (1.5 mg/70 kg) first, then Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants. All participants were randomized to receive all interventions, so all participants are combined into one Arm/Group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Peak Nicotine Levels | Peak nicotine level in each participant | Peak nicotine levels were only measured during the nicotine study intervention. One participant had incomplete serum nicotine results and was not included. | Posted | Mean | Standard Deviation | ng/ml | 0, 2, 4, 6, 8, 10, 12, 14, 16, 20, 30 minutes post-infusion |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotine | Nicotine infusion |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
Small number of subjects completed due to a large shortage of Nicotine Bitartrate (the chemical used to create our IV Nicotine). We were unable to receive new nicotine shipments from 4/14 -2/15.Without this nicotine it was impossible to run subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Lukas, Ph.D. | McLean Hospital | 617-855-2767 | slukas@mclean.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Saline - placebo | Other | Subjects received a single infusion of saline, administered over 1 minute into the antecubital vein 10 minutes into their MRI scans. |
|
| 40 minutes after infusion |
| Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With Smoking History Controlling for Nicotine | PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with smoking history (pack years) controlling for nicotine. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps. | 40 minutes after infusion |
| Final Nicotine Levels | Final nicotine level in each participant | 30 minutes post-infusion |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pack-years | calculated by reported daily cigarettes smoked divided by 20/pack and multiplied by the number of years reported smoking | Mean | Standard Deviation | pack-years |
|
| Fagerström score | Fagerstrom test for nicotine dependence: http://ndri.curtin.edu.au/btitp/documents/Fagerstrom\_test.pdf Scores ranged between 1 to 10, 1-2 = low dependence, 3-4 = low to moderate dependence, 5-7 = moderate dependence, 8+ = high dependence | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Brain Regions With a Change in Brain Activity Relative to Saline | PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps. | The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy. | Posted | Number | brain regions | 40 minutes after infusion |
|
|
|
|
| Secondary | Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With the Nicotine Time Course Controlling for Smoking History | PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course controlling for smoking history (pack years). The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps. | The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy. | Posted | Number | brain regions | 40 minutes after infusion |
|
|
|
|
| Secondary | Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With Smoking History Controlling for Nicotine | PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with smoking history (pack years) controlling for nicotine. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum-it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps. | The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy. | Posted | Number | brain regions | 40 minutes after infusion |
|
|
|
|
| Secondary | Final Nicotine Levels | Final nicotine level in each participant | One participant had incomplete serum nicotine results and was not included. | Posted | Mean | Standard Deviation | ng/ml | 30 minutes post-infusion |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | Saline | Saline infusion | 0 | 15 | 0 | 15 |
| Transient tightness in chest | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006573 |
| Heterocyclic Compounds, 1-Ring |