Not provided
Not provided
Not provided
Common comorbidities of Veterans precluded sufficient recruitment and enrollment.
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 whether sampling nicotine replacement treatments (NRTs) is superior to learning about them by computer. Testing also covers preferences among the treatments. Subjects will be enrolled veterans who smoke.
Hypothesis: Direct experience ("sampling") of NRTs will increase knowledge about NRTs, motivation/confidence, use of NRTs and quit attempts in contrast to learning about NRTs by computer.
The study was designed to compare sampling of several nicotine replacement treatments (NRTs) in contrast to a computer learning control. The NRTs include: 2 dosages of nicotine gum, 2 dosages of nicotine lozenges and 2 dosages of oral nicotine inhalers. In the sampling group, each participant tries each of the 6 NRTs for 3 minutes. In the control, the individuals read about the treatments. Dependent measures include: quit attempts, use of NRTs, preferences among NRTs, and learning and motivation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Replacement Treatment (NRT) Sampling | Active Comparator | Sampling = 3 minute testing of each of 6 NRTs (3 forms x 2 dosages) 2 mg and 4 mg nicotine gum; 2 mg and 4 mg nicotine lozenges; frequent and infrequent puffing on a nicotine inhaler (can yield 4 mg from 10 mg device). |
|
| NRT Computer Learning | Sham Comparator | Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine gum - 2 mg and 4 mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Quit Attempts, Use of NRTs, Preference Among NRTs | In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data. | At testing, at follow-up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nina G. Schneider, PhD | VA Greater Los Angeles Healthcare System, West LA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West LA | West Los Angeles | California | 90073 | United States |
25 enrollees gave their signed consent and were then screened for participation; a total of 17 participated in testing.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NRT Sampling | Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages) Nicotine gum - 2 mg and 4 mg Nicotine lozenges - 2 mg and 4 mg Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device) |
| FG001 | NRT Computer Learning | Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NRT Sampling | Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages) Nicotine gum - 2 mg and 4 mg Nicotine lozenges - 2 mg and 4 mg Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device) |
| BG001 | NRT Computer Learning |
| 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 | Quit Attempts, Use of NRTs, Preference Among NRTs | In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data. | The study was terminated and the data were not analyzed due to the small sample size. | Posted | At testing, at follow-up |
|
Not provided
Assessment of adverse events was carried out by the PI, a Study Physician, and a Research Assistant. In this study, a non-serious adverse event was one that involved expected side effects of the medications. These were monitored for the NRT Sampling Arm during testing. Side effects were not assessed for the Computer Learning intervention.
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 | NRT Sampling | Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages) Nicotine gum - 2 mg and 4 mg Nicotine lozenges - 2 mg and 4 mg Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea or Light-Headedness | Gastrointestinal disorders | Systematic Assessment | Side effects, for the non-serious events (light-headedness, nausea) were anticipated events and resolved quickly. |
Limitations of the study: early termination of the study occurred due to widespread comorbidities precluding recruitment and enrollment of Veterans in this NRT trial. Specifically, the sample size was too small for any data analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nina G. Schneider, Ph.D., Principle Investigator | Department of Veterans Affairs - VAGLA | 310-268-3059 | ngs@ucla.edu |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074164 | Nicotine Chewing Gum |
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nicotine lozenges - 2 mg and 4 mg |
| Drug |
|
|
| Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing | Drug | can yield 4 mg from 10 mg device - infrequent and frequent puffing |
|
|
| Computer learning | Other |
|
Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NRT Computer Learning |
Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only |
|
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | NRT Computer Learning | Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only | 0 | 0 | 0 | 0 |
|
Not provided
Not provided
| Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |