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| Name | Class |
|---|---|
| Foundation for a Smoke Free World INC | OTHER |
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This study will evaluate the effects of a reward devaluation strategy, which has been researched in the past, combined/augmented with the medication d-cycloserine in assisting smokers to switch from combustible cigarette (CC) to Juul.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCS with Juul e-cigarette | Experimental | d-cycloserine (DCS) 100 mg taken orally, once a day for six weeks. There will be a 50 mg dose taken the afternoon/evening prior to the first switch date (after enrollment) to ensure serum levels of the medication are available for the first switch to e-cigarette attempt. Participants will be instructed to use the Juul as often as they like during the 12 week period, and to switch completely to the Juul within 1 week. If, however, they do smoke any combustible cigarettes (CC), they will also be instructed to use the Juul immediately before each CC to relieve their craving as much as possible before smoking their usual brand. The Juul will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute Juul for CCs by the end of the first week of use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d-cycloserine | Drug | d-cycloserine (DCS) 100 mg taken orally, once a day for six weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence based on Self-Report | Complete switching from combustible cigarette use at each time point will be defined by a self-report of no cigarette smoking (not even a puff) since the prior session. | During weeks 3-6 and 9-12 post-switching date. |
| Smoking Abstinence based on Expired Air Carbon Monoxide (CO) | Complete switching from combustible cigarette use at each time point will be confirmed by an expired air CO reading of less than 5 ppm. | End of Week 6, End of Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Cigarettes Per Day | Reduction in the number of reports cigarettes smoked per day over the previous seven days (at each time point) compared to baseline. | Week 6, Week 12, Six-Month Follow-Up |
| Reduction in Expired Air Carbon Monoxide (CO) |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of daily use of D-cycloserine in conjunction with Juul | The frequency and severity of adverse events will be tabulated as well as the likelihood of their causal relationship to treatment. | Week 2, Week 6, Week 8, Week 12 |
Inclusion Criteria:
Exclusion Criteria:
Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).
Patient Health Questionnaire (PHQ-9) score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
Planned use of an FDA-approved smoking cessation product during the study.
High Blood Pressure (systolic >150 mm Hg, diastolic >95 mm Hg) at screening.
Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure.
Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study.
Taking antidepressants or psychoactive medications (e.g., antipsychotics, antidepressants, benzodiazepines, hypnotics).
Use of any of these products in the past 30 days:
Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black & Mild" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.
Pregnant or nursing (by self-report) or positive pregnancy test.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rose Research Center | Charlotte | North Carolina | 28262 | United States | ||
| Rose Research Center |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Juul e-cigarette | Other | Juul use as often as the participant likes for 12 weeks. |
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Reduction in Expired Air Carbon Monoxide (CO) compared to baseline.
| End of Week 6, End of Week 12 |
| Change in rewarding effects for cigarettes and e-cigarettes at 6 weeks post switch | o assess subjective satisfaction and other perceived rewarding or aversive effects accompanying e-cigarette use and combustible cigarette use using the modified (e-Cigarette) Cigarette Evaluation Questionnaire. This questionnaire contains five subscale scores: smoking satisfaction (satisfying, tastes good, enjoy smoking), psychological rewards (calms down, more awake, less irritable, helps concentrate, reduces hunger), aversion (dizziness, nauseated), enjoyment of respiratory tract sensations (single-item assessment), craving reduction (single-item assessment). Participants will be asked to assess the 12 items of the questionnaire on a 7-point scale, ranging from "1-not at all" to "7-extremely". | End of Week 6 |
| Raleigh |
| North Carolina |
| 27617 |
| United States |
| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |