CompletedPhase 1/2

Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders

United States775 participantsStarted 2016-10-07

Plain-language summary

This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Adults with affective disorders are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health consequences, including site-specific cancers, heart disease, and premature death. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like those with affective disorders who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap. This same study was also conducted in two additional vulnerable populations under a similar protocol.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or Female * Ages 18-70 * Past-year major depressive disorder, dysthymic disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, phobia, or panic disorder with or without agoraphobia, based on Mini-Neuropsychiatric Interview (MINI) structured interview, OR lifetime diagnosis of one of the above based on MINI with a self-report of currently receiving treatment (prescribed psychoactive medication, behavioral therapy, etc.) * Report smoking 5 or more cigarettes per day for the past year * Provide an intake breath Carbon Monoxide (CO) sample \> 8 ppm * Be without current substance abuse/dependence other than nicotine * Be sufficiently literate to complete the research-related tasks * Be in good physical health without serious illness or change in health in the past 3 months as determined by the licensed medical professional at each site * Not pregnant or nursing and report using oral, implant, patch, ring, intrauterine device (IUD), injection or barrier contraceptives or report being surgically sterile or post-menopausal * Report no significant use of other tobacco or nicotine products within the past month (\> 9 days in the past 30) Exclusion Criteria: * Any prior regular use (used as primary cigarette outside of the laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content) * Exclusive use of roll-your-own cigarettes * Planning to quit smoking in the next 30 days * A qu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cigarettes Per Day (CPD)

Timeframe: 12 weeks

Trial details

NCT IDNCT02232737

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-14

Results submitted2022-10-11

View on ClinicalTrials.gov More Tobacco Use Disorder trials