Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers
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ClinicalTrials.gov Identifier: NCT02587312 |
Recruitment Status :
Completed
First Posted : October 27, 2015
Last Update Posted : January 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Nicotine Dependence | Other: Very low nicotine content cigarettes Other: Standard nicotine content cigarettes | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers |
Actual Study Start Date : | October 13, 2016 |
Actual Primary Completion Date : | August 28, 2019 |
Actual Study Completion Date : | August 31, 2019 |

Arm | Intervention/treatment |
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Active Comparator: Normal Nicotine Content Cigarettes
SPECTRUM cigarette: 0.8 mg nicotine with 10.5 mg tar (standard nicotine and tar yields of commercially available cigarettes; control condition)
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Other: Standard nicotine content cigarettes |
Experimental: Very Low Nicotine Content Cigarettes
SPECTRUM cigarette: 0.03 mg nicotine with 9 mg tar
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Other: Very low nicotine content cigarettes |
- Number of cigarettes smoked per day [ Time Frame: End of 3-week intervention ]

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Ages Eligible for Study: | 15 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- current daily smoking (1 or more cigarettes per day for the past 6 months or longer). Participants must meet a breath carbon monoxide criterion of 6 ppm or higher; if this is not met, urine cotinine levels, detected by a NicAlert cotinine screening device, must indicate recent smoking (level 3 or higher).
- Participants must speak and comprehend English well enough to complete study procedures.
Exclusion Criteria:
- Current pregnancy
- Self-reported daily use of alcohol or other non-prescribed drugs (excluding marijuana).
- Participants who are seeking treatment for their smoking or who report that they intend to quit smoking within the next 30 days and have made a 24-hour quit attempt in the past year
- Participants who report current suicidal ideation on the MINI suicide subscale questions 4 & 5 ("In the past month did you have a suicide plan?" and "In the past month did you attempt suicide?"), as well as participants who indicate that they have made a suicide attempt in their lifetime

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587312
United States, Rhode Island | |
Brown University School of Public Health | |
Providence, Rhode Island, United States, 02912 |
Responsible Party: | Rachel N Cassidy, Assistant Professor, Brown University |
ClinicalTrials.gov Identifier: | NCT02587312 |
Other Study ID Numbers: |
1K01CA189300 ( U.S. NIH Grant/Contract ) |
First Posted: | October 27, 2015 Key Record Dates |
Last Update Posted: | January 18, 2020 |
Last Verified: | January 2020 |
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Nicotine Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |