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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA029689 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to determine the timeframe (relative to a stress task) that is most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with stressful situations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Lozenge Immediately Prior to Stress task | Experimental | Subjects will receive the nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
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| Nicotine lozenge 10 Minutes prior to Stress task | Experimental | Subjects will receive the nicotine lozenge after the stress task during one laboratory session and immediately prior to the stress task at the other laboratory session |
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| Nicotine lozenge 20 minutes prior to Stress task | Experimental | Subjects will receive the nicotine lozenge after the stress task during one laboratory session and 10 minutes prior to the stress task at the other laboratory session |
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| Nicotine Lozenge 30 minutes prior to stress taks | Experimental | Subjects will receive the nicotine lozenge 10 minutes prior to the stress task during one laboratory session and after the stress task at the other laboratory session |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine lozenge | Drug | A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task |
|
| Measure | Description | Time Frame |
|---|---|---|
| Craving | The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges. | Baseline, 6 months |
| Nicotine Withdrawal Symptoms | The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity. | 5 to 35 minutes |
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Inclusion Criteria:
Exclusion Criteria:
The investigators will evaluate if there are other reasons why someone may not participate
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kotlyar, PharmD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Sciences Institute | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28235705 | Derived | Kotlyar M, Lindgren BR, Vuchetich JP, Le C, Mills AM, Amiot E, Hatsukami DK. Timing of nicotine lozenge administration to minimize trigger induced craving and withdrawal symptoms. Addict Behav. 2017 Aug;71:18-24. doi: 10.1016/j.addbeh.2017.02.018. Epub 2017 Feb 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Lozenge Immediately Prior to Stress Task. | Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
| FG001 | Nicotine Lozenge 10 Min Prior to Stress Task | Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
| FG002 | Nicotine Lozenge 20 Min Prior to Stress Task | Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
| FG003 | Nicotine Lozenge 30 Min Prior to Stress Task | Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only those that completed the entire cross-over study were included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Lozenge Immediately Prior to Stress Task. | Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
| BG001 | Nicotine Lozenge 10 Min Prior to Stress Task |
| 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 | Craving | The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, 6 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 | Nicotine Lozenge Prior to Stress Task | Subjects will receive the nicotine lozenge at one of four time-points prior to the stress task at the first laboratory session and after the stress task at the second laboratory session Nicotine lozenge 4 mg: A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kotlyar | University of Minnesota | 6126251160 | kotly001@umn.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 |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
| BG002 | Nicotine Lozenge 20 Min Prior to Stress Task | Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
| BG003 | Nicotine Lozenge 30 Min Prior to Stress Task | Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
| OG002 | Nicotine Lozenge 20 Min Prior to Stress Task | Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
| OG003 | Nicotine Lozenge 30 Min Prior to Stress Task | Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session |
|
|
| Primary | Nicotine Withdrawal Symptoms | The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 5 to 35 minutes |
|
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | Nicotine Lozenge After Stress Task | Subjects will receive the nicotine lozenge after the stress task during the first laboratory session and prior to the stress task at the second laboratory session Nicotine lozenge 4 mg: A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task | 0 | 98 | 0 | 98 |
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