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This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers. Groups' (placebo vs. insulin) cognitive function and stress response will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Insulin | Experimental | Intranasal Insulin |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Insulin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Episodic Memory | California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome | 90 minutes |
| Salivary Cortisol | 90 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Craving (Measured by Questionnaire of Smoking Urges) | Questionnaire of Smoking Urges; Total Range= 10-70; Higher values represent worse outcome | 90 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNM College of Pharmacy | Albuquerque | New Mexico | 87131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Insulin | Group receiving active treatment |
| FG001 | Placebo | Group receiving placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Insulin | Group receiving active treatment |
| BG001 | Placebo | Group receiving placebo |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Episodic Memory | California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome | Posted | Mean | Standard Error | number of words recalled | 90 minutes |
|
|
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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 | Intranasal Insulin | Group receiving active treatment | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinorrhea | General disorders | Non-systematic Assessment | Nasal Occurrences |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ajna Hamidovic | University of Illinois College of Pharmacy | 312-355-1713 | ahamidov@uic.edu |
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|
| Withdrawal by Subject |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
|
|
| Primary | Salivary Cortisol | Posted | Mean | Standard Error | mcg/dL | 90 minutes |
|
|
|
| Other Pre-specified | Nicotine Craving (Measured by Questionnaire of Smoking Urges) | Questionnaire of Smoking Urges; Total Range= 10-70; Higher values represent worse outcome | Posted | Mean | Standard Error | units on a scale | 90 minutes |
|
|
|
| 27 |
| 0 |
| 27 |
| 25 |
| 27 |
| EG001 | Placebo | Group receiving placebo | 0 | 24 | 0 | 24 | 13 | 24 |
| Smell | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Tingling | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Irritation | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Sneezing | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Numbness | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Burning | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Sensitivity | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Pressure | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Congestion | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Bleeding | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Dryness | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Pressure (ears) | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Pressure (eye) | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Dizziness | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Taste | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Sweating | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Bruising | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Headache | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Stomach Pain | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Blurry Vision | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Tingling (throat) | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Confusion | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Numbness (arm) | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Tingling (mouth) | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Cold | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Shaking | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Anxiety | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Itchiness | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Diarrhea | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Difficulty Breathing | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Fatigue | General disorders | Non-systematic Assessment | Other Occurrences |
|
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