Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Insulin First | Active Comparator | Intranasal Insulin First, Placebo Second |
|
| Placebo First | Placebo Comparator | Placebo First, Intranasal Insulin Second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Insulin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Amount Eaten in Taste Test | 90 minutes |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Cravings Measured by Questionnaire of Smoking Urges | Range: 7-70. Higher scores mean worse outcome | 210 minutes |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ajna Hamidovic, PharmD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNM College of Pharmacy | Albuquerque | New Mexico | 87131 | United States | ||
| UNM College of Pharmacy |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Insulin Arm | Active Treatment First |
| FG001 | Placebo | Placebo treatment first |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo first |
| BG001 | Intranasal Insulin Arm | Active treatment first |
| 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 | Amount Eaten in Taste Test | Posted | Mean | Standard Deviation | grams | 90 minutes |
|
|
240 minutes
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 | Intranasal Insulin | Group Receiving Intranasal Insulin | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation | General disorders | Non-systematic Assessment | Nasal Occurrences |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ajna Hamidovic | University of Illinois at Chicago | 312-355-1713 | ahamidov@uic.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Albuquerque |
| New Mexico |
| United States |
| IV placement difficulty |
|
| Current Illness |
|
| 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 |
|
|
| Other Pre-specified | Nicotine Cravings Measured by Questionnaire of Smoking Urges | Range: 7-70. Higher scores mean worse outcome | Posted | Mean | Standard Error | score on a scale | 210 minutes |
|
|
|
| 26 |
| 0 |
| 26 |
| 11 |
| 26 |
| EG001 | Placebo | Group Receiving Placebo | 0 | 24 | 0 | 24 | 7 | 24 |
| EG002 | Follow up | Total Participants Completed Study | 0 | 19 | 0 | 19 | 5 | 19 |
| Dizziness | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Headache | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Confusion | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Tingling (mouth) | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Shaking | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Smell | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Sneezing | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Congestion | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Pain | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Fainter Sniffin Sticks | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Nasal Abrasions | General disorders | Non-systematic Assessment | Nasal Occurrences |
|
| Sweating | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Visual Disturbances | 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 |
|
| Fatigue | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Body Pain | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Menorrhagia | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Restlessness | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Confined | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Uncomfortable | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Eyes Watering | General disorders | Non-systematic Assessment | Other Occurrences |
|
| Hunger | General disorders | Non-systematic Assessment | Other Occurrences |
|
Not provided
Not provided
Not provided