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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA192940-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to see whether adults who use e-cigarettes every day experience symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.
Study Design: The investigators will recruit 120 individuals who are long-term daily and exclusive users of nicotine-containing e-cigarettes. Participants will be asked to use their own e-cigarette as usual during the first week of the study and to then stop their use of e-cigarettes for 6 days. The total study duration will be 14 days. Participants will be instructed to continue abstinence from other tobacco and nicotine products during the entire study. The investigators will use an escalating payment system with bonuses based on breath and urine samples to encourage compliance.
Every day during the study, participants will report e-cigarette and tobacco cigarette use and monitor symptoms of nicotine withdrawal via a phone call to an Interactive Voice Response system. Participants will attend 3 study visits each week to provide urine and breath samples to verify compliance, and to complete brief surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abstinence from e-cigarettes | Experimental | Participants abstain from e-cigarettes and other nicotine/tobacco products for 6 days |
|
| E-cigarette use | No Intervention | Participants use e-cigarettes and continue to abstain from tobacco/nicotine products as they normally would. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abstinence from e-cigarettes | Behavioral | Abrupt cessation for 6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total score on the Minnesota Nicotine Withdrawal Scale (MNWS) | The investigators will compare the mean score across participants for the entire 6-day abstinence vs. use conditions. | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS) | The investigators will use the mean score for each of the 16 symptoms across participants during abstinence and use conditions. | 6 days |
| Questionnaire of E-cigarette Urges (brief) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John R Hughes, MD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Battelle Memorial Institute | Baltimore | Maryland | 21209 | United States | ||
| University of Vermont |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31504882 | Derived | Hughes JR, Peters EN, Callas PW, Peasley-Miklus C, Oga E, Etter JF, Morley N. Withdrawal Symptoms From E-Cigarette Abstinence Among Adult Never-Smokers: A Pilot Experimental Study. Nicotine Tob Res. 2020 Apr 21;22(5):740-746. doi: 10.1093/ntr/ntz169. | |
| 31352486 | Derived | Hughes JR, Peters EN, Callas PW, Peasley-Miklus C, Oga E, Etter JF, Morley N. Withdrawal Symptoms From E-Cigarette Abstinence Among Former Smokers: A Pre-Post Clinical Trial. Nicotine Tob Res. 2020 Apr 21;22(5):734-739. doi: 10.1093/ntr/ntz129. |
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| ID | Term |
|---|---|
| D013375 | Substance Withdrawal Syndrome |
| D000072137 | Vaping |
| D040261 | Harm Reduction |
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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This is a revision of the brief version Questionnaire of Smoking Urges that asks about urges for e-cigarettes rather than tobacco cigarettes.
| 6 days |
| Questionnaire of Smoking Urges- brief version | This 2-item scale asks about intensity and frequency of urges. | 6 days |
| Heart rate | Measured for 30 sec after sitting for 15 minutes | 6 days |
| E-cigarette Purchase Task | This is a modification of the Cigarette Purchase Task that asks how much users would expend to obtain their usual amount of e-liquids to use. | 6 days |
| Burlington |
| Vermont |
| 05401 |
| United States |
| D015438 |
| Health Behavior |