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Low Nicotine Cigarettes and E-Cigarettes for Mood Disorders

Phase 2
Waitlist Available
Led By Jennifer W Tidey, Ph.D.
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial will study the effect of reducing the nicotine in cigarettes and making e-cigarettes available in either one flavor or multiple flavors on daily smokers with current ADs.

Who is the study for?
This trial is for daily smokers aged 21 to 70 with Affective Disorders. It's not open to those who don't have an Affective Disorder or are outside the age range.Check my eligibility
What is being tested?
The study tests if low nicotine cigarettes (0.4mg/g) and e-cigarettes, either tobacco-flavored or in various flavors, can reduce smoking in people with mood disorders. Participants will use their assigned products exclusively for 16 weeks.See study design
What are the potential side effects?
Potential side effects may include craving, withdrawal symptoms from reduced nicotine intake, changes in psychiatric symptoms due to alterations in smoking habits, and possible reactions to different e-cigarette flavors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cigarettes Per Day

Trial Design

4Treatment groups
Experimental Treatment
Group I: RC 2 onlyExperimental Treatment1 Intervention
Research Cigarettes #2
Group II: RC 2 + EC 2Experimental Treatment2 Interventions
Research Cigarettes #2 plus E-cigarettes #2 (participants can choose among varying flavors)
Group III: RC 2 + EC 1Experimental Treatment2 Interventions
Research Cigarettes #2 plus E-cigarettes #1 (participants receive tobacco flavor only)
Group IV: RC 1 onlyExperimental Treatment1 Intervention
Research Cigarettes #1

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
456 Previous Clinical Trials
562,849 Total Patients Enrolled
17 Trials studying Tobacco Use Disorder
3,565 Patients Enrolled for Tobacco Use Disorder
Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,374 Total Patients Enrolled
9 Trials studying Tobacco Use Disorder
1,768 Patients Enrolled for Tobacco Use Disorder
National Institute on Drug Abuse (NIDA)NIH
2,461 Previous Clinical Trials
2,616,837 Total Patients Enrolled
271 Trials studying Tobacco Use Disorder
48,835 Patients Enrolled for Tobacco Use Disorder

Media Library

Low Nicotine Content Cigarettes (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04090879 — Phase 2
Tobacco Use Disorder Research Study Groups: RC 2 + EC 1, RC 2 only, RC 1 only, RC 2 + EC 2
Tobacco Use Disorder Clinical Trial 2023: Low Nicotine Content Cigarettes Highlights & Side Effects. Trial Name: NCT04090879 — Phase 2
Low Nicotine Content Cigarettes (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04090879 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit of this medical trial extend beyond fifty years?

"To be eligible for this clinical research, applicants must fall between the age brackets of 18 to 70. There are 254 studies enrolling participants under 18 and 704 recruiting those aged over 65."

Answered by AI

Is the research team presently seeking participants for this investigation?

"Affirmative. Evidence on clinicaltrials.gov indicates that this trial, which began recruiting patients on September 18th 2019, is still in search of participants. The study requires 232 people to be recruited from two distinct locations."

Answered by AI

What are the potential health hazards of using E-Cigarettes?

"Power's team assigned E-Cigarettes a rating of 2 due to the lack of evidence for efficacy, yet some data indicating its safety. This is in keeping with its Phase 2 trial status."

Answered by AI

How many applicants are being admitted to this research trial?

"Affirmative, the clinicaltrials.gov page conveys that this medical trial is actively searching for volunteers. This research was first published on September 18th 2019 and last modified on July 19th 2022 with a goal to enroll 232 people from 2 centres."

Answered by AI

May I join in this medical research project?

"This research project is searching for 232 volunteers that have a history of nicotine dependence and fit the following parameters: aged between 18-70, diagnosed with an Affective Disorder, and no older than 70 years old."

Answered by AI

Who else is applying?

What site did they apply to?
Brown University
What portion of applicants met pre-screening criteria?
Met criteria

What questions have other patients asked about this trial?

what should i expect during the screenings?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

i really hope this trail can lead me in the right direction to better my mental health & help me understand how nicotine is effecting me.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders
Jennifer Tidey 2019. "Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04090879.
~42 spots leftby Apr 2025
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