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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-04102 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R01DA057327 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.
PRIMARY OBJECTIVES:
I. Determine PEC versus vs. TEC vs. nicotine replacement therapy (NRT) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked.
II. Examine PEC vs. TEC vs. NRT on cigarette craving, withdrawal symptoms, and perceived nicotine dependence.
III. Examine PEC vs. TEC on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks.
OUTLINE: Participants are randomized to 1 of 3 arms.
ARM I: Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.
ARM II: Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage.
ARM III: Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage.
Participants in all arms participate in discussions throughout the trial.
SURVEILLANCE PHASE: Participants in all arms are followed for 12-weeks after completion of study procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (PEC) | Experimental | Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial. |
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| Arm II (TEC) | Experimental | Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial. |
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| Arm III (NRT) | Active Comparator | Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement | Drug | Given nicotine patches and nicotine lozenges |
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| Measure | Description | Time Frame |
|---|---|---|
| 7-day point prevalence complete switching rate | Self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days), any reported use of ECs or NRT over the past 7 days, and an exhaled CO reading of ≤6ppm. | At week 14 |
| Biochemically verified 7-day point prevalence abstinence from cigarettes | Biochemical verification of abstinence from cigarettes (exhaled CO reading of ≤6ppm) combined with self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days). | At week 14 |
| Cigarettes smoked per day | Cigarettes smoked per day as evaluated with the timeline follow-back questionnaire. | At week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cigarettes smoked per day | Changes in cigarettes smoked per day from baseline to 26 weeks will be evaluated with the timeline follow-back questionnaire. | From baseline to 26 weeks |
| Change in nicotine dependence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Theodore L Wagener, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Questionnaire Administration | Other | Ancillary studies |
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| Vaping | Device | Given Preferred Flavor e-liquid |
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| Vaping | Device | Given Tobacco flavored e-liquid |
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Among participants abstaining from smoking, changes in nicotine dependence from baseline to 14 weeks will be assessed in the PEC, TEC, and NRT arms with the PROMIS nicotine dependence scale. Scores range from 0 to 16 with higher scores indicating greater dependence.
| From baseline to 14 weeks |
| Changes in cigarette craving and nicotine withdrawal | Cigarette craving and nicotine withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS). Total MPSS scores range from 12 to 60 with higher scores indicating a greater severity of tobacco withdrawal symptoms. | At baseline, 2, 6, 14, and 26 weeks |
| Number of days used in past week | The number of days the study products are used in the past 7 days during the period of product provision in the PEC and TEC arms. | At 2, 6, and 14 weeks |
| Number of days used in past month | The number of days the study products are used in the past 30 days during the period of product provision in the PEC and TEC arms. | At 6 and 14 weeks |
| Product appeal | EC appeal is measured with the modified Cigarette Evaluation Questionnaire (mCEQ) to assess subjected responses to ECs (e.g., reward, satisfaction). | At 2, 6, 14, and 26 weeks |
| Continued use of ECs | The proportion of participants who continue to use ECs between 14 and 26 weeks in the PEC and TEC arms. | From 14 to 26 weeks |
| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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