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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA015596 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patch+spray | Experimental | Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray. |
|
| patch+placebo spray | Placebo Comparator | Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 21mg transdermal nicotine patch (Nicoderm CQ) | Drug | 21mg transdermal nicotine patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinks Consumed During an Ad-libitum Drinking Period | Participants are presented with alcohol beverages and allowed to drink at their leisure. | Two hour ad-libitum drinking period during laboratory session |
| Measure | Description | Time Frame |
|---|---|---|
| Craving for Alcohol | Alcohol craving was measured using the Alcohol Urge Questionnaire (AUQ). The range of scores is 1-100 on a visual analog scale (VAS). Higher scores indicate higher levels of craving. Score indicated is the total score. | first measurement during laboratory session (+60 minutes after beginning of laboratory session) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry A McKee, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center & Yale-New Haven Hospital | New Haven | Connecticut | 06519 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Patch+Spray First, Then Nicotine Patch+Placebo Spray | Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch 1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol. Or Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale. |
| FG001 | Nicotine Patch+Placebo Spray First, Then Nicotine Patch+Spray | Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch 1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol. Or Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Day) |
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| Second Intervention (1 Day) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Patch + Nicotine Spray; Nicotine Patch+Placebo Spray | Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray and the other session they receive nicotine patch + placebo nasal spray. The order is counter-balanced. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch 1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service (IDS) at Yale-New Haven Hospital. It is similar in concentration to Nicotrol. Or Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray. Formulated by IDS at Yale. |
| 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, 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 | Number of Drinks Consumed During an Ad-libitum Drinking Period | Participants are presented with alcohol beverages and allowed to drink at their leisure. | Posted | Mean | Standard Deviation | drinks | Two hour ad-libitum drinking period during laboratory session |
|
During laboratory session, subjects responded to a list of potential symptoms. Symptoms were assessed 5 hours after nicotine administration.
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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 | Patch+Spray | Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + nicotine nasal spray. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch 1mg nicotine nasal spray: two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherry McKee | Yale University | (203) 737-3529 | sherry.mckee@yale.edu |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| 1mg nicotine nasal spray | Drug | two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol. |
|
| placebo nasal spray | Drug | saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. |
|
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. |
|
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| Secondary | Craving for Alcohol | Alcohol craving was measured using the Alcohol Urge Questionnaire (AUQ). The range of scores is 1-100 on a visual analog scale (VAS). Higher scores indicate higher levels of craving. Score indicated is the total score. | Posted | Mean | Standard Error | units on a scale | first measurement during laboratory session (+60 minutes after beginning of laboratory session) |
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|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 17 |
| 22 |
| EG001 | Patch+Placebo Spray | Within subject design. All volunteers complete two laboratory sessions. In one session they receive nicotine patch + placebo nicotine nasal spray. 21mg transdermal nicotine patch (Nicoderm CQ): 21mg transdermal nicotine patch placebo nasal spray: saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. | 0 | 22 | 0 | 22 | 11 | 22 |
| Heart rate > 100 | Cardiac disorders | Systematic Assessment |
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| Dizziness/light headed | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal discomfort | General disorders | Systematic Assessment |
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| Nasal irritation | General disorders | Systematic Assessment |
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| Throat irritation | General disorders | Systematic Assessment |
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| Eyes watering | General disorders | Systematic Assessment |
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| hands or feet cold | General disorders | Systematic Assessment |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |