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
The purpose of this study is to determine if changing the timeframe (relative to cue presentation) at which the nicotine lozenge is given can attenuate the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with smoking cues. In this cross-over study, all subjects attend three laboratory sessions at which either nicotine lozenge or placebo is given prior to presentation of smoking cues or after presentation of smoking cues. The order in which the three conditions will be presented are randomized.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine lozenge 4 mg prior to cue exposure | Experimental | Nicotine lozenge is used 15 minutes prior to smoking cue exposure |
|
| Placebo lozenge prior to cue exposure | Placebo Comparator | Placebo lozenge is used 15 minutes prior to smoking cue exposure |
|
| Control condition: Lozenge after cue exposure | Other | Lozenge is used immediately after smoking cue exposure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine lozenge 4 mg | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Craving Symptom Severity Score Assessed Via Questionnaire | Craving as assessed via the craving question on the Minnesota Nicotine Withdrawal Scale. The score range is from 0 (no craving) to 4 (severe craving). The outcome measure is the change in craving score from before cue exposure to craving score after cue exposure. | approximately 15 minutes |
| Withdrawal Symptom Severity Score Assessed Via Questionnaire | Withdrawal as assessed via the Minnesota Nicotine Withdrawal Scale. The score range is from 0 to 28 with higher scores indicating more severe withdrawal symptoms. The outcome measure is the change in withdrawal score from before cue exposure to the withdrawal score after cue exposure. | approximately 15 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
The investigators will evaluate if there are other reasons why someone may not participate
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3 |
| FG001 | Sequence 2 | Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3 |
| FG002 | Sequence 3 | Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3 |
| FG003 | Sequence 4 | Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3 |
| FG004 | Sequence 5 | Nicotine lozenge after cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3 |
| FG005 | Sequence 6 | Nicotine lozenge after cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3 |
| BG001 | Sequence 2 |
| 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 | Craving Symptom Severity Score Assessed Via Questionnaire | Craving as assessed via the craving question on the Minnesota Nicotine Withdrawal Scale. The score range is from 0 (no craving) to 4 (severe craving). The outcome measure is the change in craving score from before cue exposure to craving score after cue exposure. | Posted | Least Squares Mean | Standard Error | units on a scale | approximately 15 minutes |
|
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 Lozenge Prior to Cue Exposure | Nicotine lozenge is used 15 minutes prior to smoking cue exposure Nicotine lozenge 4 mg |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kotlyar | University of Minnesota | 612-251-8780 | kotly001@umn.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 |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo lozenge |
| Drug |
|
Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
| BG002 | Sequence 3 | Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3 |
| BG003 | Sequence 4 | Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3 |
| BG004 | Sequence 5 | Nicotine lozenge after cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3 |
| BG005 | Sequence 6 | Nicotine lozenge after cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3 |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Control Condition: Lozenge After Cue Exposure | Lozenge is used immediately after smoking cue exposure Nicotine lozenge 4 mg |
|
|
|
| Primary | Withdrawal Symptom Severity Score Assessed Via Questionnaire | Withdrawal as assessed via the Minnesota Nicotine Withdrawal Scale. The score range is from 0 to 28 with higher scores indicating more severe withdrawal symptoms. The outcome measure is the change in withdrawal score from before cue exposure to the withdrawal score after cue exposure. | Posted | Least Squares Mean | Standard Error | units on a scale | approximately 15 minutes |
|
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Placebo Lozenge Prior to Cue Exposure | Placebo lozenge is used 15 minutes prior to smoking cue exposure Placebo lozenge | 0 | 46 | 0 | 46 |
| EG002 | Control Condition: Lozenge After Cue Exposure | Lozenge is used immediately after smoking cue exposure Nicotine lozenge 4 mg | 0 | 45 | 0 | 45 |
Not provided