Status:
COMPLETED
Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Dependence, Cigarettes, Uncomplicated
Eligibility:
All Genders
15-20 years
Phase:
PHASE1
PHASE2
Brief Summary
Adolescents are an important vulnerable population to consider as the FDA moves toward a nicotine reduction policy. Such a policy, which would mandate a reduction of nicotine in all commercially avail...
Eligibility Criteria
Inclusion
- 1\) Ages 15-20 inclusive 2) Male and female current daily smokers
- Defined as self-reported daily cigarette smoking at phone screening AND
- a breath carbon monoxide (CO) criterion of 5 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) 3) Current users of alternative tobacco product(s)
- a. Defined as any self-reported use of at least one non-cigarette tobacco product (e.g., e-cigarettes, little cigars, cigarillos, hookah, etc.) in the past 30 days 4) Participants must speak and comprehend English well enough to complete study procedures.
- a. Participant will be asked to read aloud first few lines of informed consent and then summarize the contents aloud to check for competency 5) Participants under 18 must provide assent and parental consent from a parent/guardian.
- a. Participants age 18 or 19 may provide their own written consent contingent on photo ID verification of age.
Exclusion
- 1\) Unwilling to use research cigarettes as part of the study 2) Self-reported daily drinking of alcohol or use of illicit or non-prescribed drugs (excluding marijuana) \> 10 days in the past 30 days
- a. We will ask about daily alcohol and drug use in the phone screen, and we will use the Timeline Follow-Back to assess current and recent marijuana and alcohol use.
- 3\) Currently seeking treatment to quit smoking, and/or intending to quit smoking for good in the next 30 days
- This information corresponds to questions 2 \& 3 of the Stages of Change measure which will be administered at the in-person screening.
- These participants will be excluded, and provided with referral information for cessation services in the community.
- 4\) Suicidal ideation in the past month or any past-year suicide attempts
- a. Suicidal ideation determined by the MINI ( Mini International Neuropsychiatric Interview) suicide subscale at the in-person screening (Questions 4 and 5) b. Suicide attempt in the past year determined by MINI question 6.a. (If participant has a lifetime history of suicide attempt between 1 and 10 years ago, licensed medical monitor approval required) c. If a participant indicates that he/she currently has suicidal ideation during this or any future session, the Emergency Protocol will be followed in which a Licensed Clinician will be contacted immediately, and participants will speak with the clinician over the phone and the clinician will determine the appropriate action to take to keep the child safe.
- 5\) Pregnant or breastfeeding
- a. Determined by urine test at in-person screening; tested again at each in-person visit; participant will be excluded or withdrawn if test indicates pregnancy b. Self-reports current breastfeeding at in-person screening 6) Any medical or psychiatric conditions in which participation is likely to pose a significant threat to health or for which the condition could interfere with the ability of the participant to fully participate (as determined by LMP).
- 7\) Having participated in another research study during the past year in which they were switched to research cigarettes for longer than one week.
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2022
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03860077
Start Date
October 10 2019
End Date
March 23 2022
Last Update
December 19 2023
Active Locations (1)
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1
Brown University School of Public Health
Providence, Rhode Island, United States, 02912