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Colored Packaging for Cigarette Smoking

N/A
Recruiting
Led By Andrew Strasser, Ph.D.
Research Sponsored by Andrew Strasser
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Not currently undergoing smoking cessation treatment or planning to quit over the duration of the study (~5 weeks)
Self-report smoking at least 5 non-menthol, filtered cigarettes per day for at least the last 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 5, 10, 20 and 35
Awards & highlights

Study Summary

This trial looks at how different colors on cigarette packaging affects how much people smoke and their perceptions of risk.

Who is the study for?
This trial is for individuals who smoke at least 5 non-menthol, filtered cigarettes daily for the past year and plan to stay in the study area for about 5 weeks. They must not be trying to quit smoking or participating in cessation treatment during the study, speak English fluently, and give informed consent. Pregnant women, those planning pregnancy, heavy drinkers, people with certain mental health conditions or serious medical issues are excluded.Check my eligibility
What is being tested?
The study investigates how changing cigarette package color affects smokers' behaviors and perceptions when using low nicotine content (LNC) cigarettes compared to their own brand of regular cigarettes.See study design
What are the potential side effects?
While this trial does not involve a drug intervention that typically has side effects, participants may experience changes in smoking behavior or perceptions due to switching from their usual brand to LNC cigarettes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not trying to quit smoking nor plan to during the study.
Select...
I have smoked 5 or more non-menthol, filtered cigarettes daily for the last year.
Select...
I have smoked 5 or more non-menthol, filtered cigarettes daily for the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 5, 10, 20 and 35
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 5, 10, 20 and 35 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Carbon Monoxide (CO)
Daily Cigarette Consumption
Total NNAL
+2 more
Secondary outcome measures
Cigarette Craving (Questionnaire on Smoking Urges [QSU])
Cigarette Risk Beliefs
Cigarette Withdrawal (Withdrawal Symptom Checklist [WSC])
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Own BrandExperimental Treatment1 Intervention
After completing a 5-day baseline period of smoking their own brand, participants will complete a 30-day experimental period when they will continue to receive their own preferred brand of cigarettes (i.e., control group).
Group II: LNC Cigarettes + Red PackagingExperimental Treatment1 Intervention
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in red packaging.
Group III: LNC Cigarettes + Plain PackagingExperimental Treatment1 Intervention
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in plain packaging.
Group IV: LNC Cigarettes + Gray PackagingExperimental Treatment1 Intervention
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in standard investigational packaging (gray).
Group V: LNC Cigarettes + Blue PackagingExperimental Treatment1 Intervention
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in blue packaging.

Find a Location

Who is running the clinical trial?

Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,031 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,772 Total Patients Enrolled
University of PennsylvaniaOTHER
1,994 Previous Clinical Trials
42,878,681 Total Patients Enrolled

Media Library

LNC Cigarettes (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03802019 — N/A
Smoking/Cigarette Smoking Research Study Groups: LNC Cigarettes + Blue Packaging, LNC Cigarettes + Red Packaging, LNC Cigarettes + Plain Packaging, LNC Cigarettes + Gray Packaging, Own Brand
Smoking/Cigarette Smoking Clinical Trial 2023: LNC Cigarettes Highlights & Side Effects. Trial Name: NCT03802019 — N/A
LNC Cigarettes (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03802019 — N/A
Smoking/Cigarette Smoking Patient Testimony for trial: Trial Name: NCT03802019 — N/A

Frequently Asked Questions

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

Is the minimum age requirement for this research greater than twenty years?

"This medical trial is seeking volunteers that are of legal age (21+) and younger than 65 years old."

Answered by AI

What is the participant count for this research project?

"Affirmative. Data hosted on clinicaltrials.gov certifies that this medical trial, first published on September 18th 2019, is actively recruiting patients. 575 participants are needed to be enrolled from a single research centre."

Answered by AI

Am I appropriate to join in this trial?

"This clinical trial is looking for 575 smokers aged 21 to 65 who are willing to comply with the requirements detailed in the consent and HIPAA form. Furthermore, candidates must not be engaging in smoking cessation therapy or intent on quitting during the five-week long study period. Similarly, they have to possess fluency of English (both orally & written) as well as have a history of consuming at least 5 non-menthol cigarettes daily over the last year."

Answered by AI

Is this trial actively seeking participants?

"Clinicaltrials.gov connotes that this medical trial is actively searching for participants, with recruitment having commenced on September 18th 2019 and the information being recently revised on March 18th 2022."

Answered by AI

What core objectives are the investigators attempting to prove with this research project?

"This research study, which will be assessed over the 5th and 35th day marks, seeks to quantify Total Puff Volume/Puff Duration. Secondary endpoints include Cigarette Craving (as determined by a summary score and two factor subscales derived from the 32-item Questionnaire on Smoking Urges [QSU]), Total Puff Count (calculated through video recordings of smoking sessions), as well as Subjective Cigarette Ratings (a 14-item 100mm Visual Analog Scale [VAS] that indexes cigarette characteristics)."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Center for Interdisciplinary Research for Nicotine Addiction
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

The study looks interesting. This is my first time doing a clinical studies.
PatientReceived 2+ prior treatments
Interested more need more information to make a confident decision. I was motivated to contact you first off because I'm out of work right now but second I've been a lot of clinical research studies and I've always did very well I was actually a leader to Google a couple times I'm pretty smart and all different fields I put backgrounds and everything well I didn't finish college sorry. But if you give me a shy really appreciate it cuz I'm struggling with my family right now got eight people living in a three bedroom house. Same thing would help even if I get picked for one study for the year I saw it to go on cuz the last time I went out getting paid $1,500 and then the next time I went it was almost as long and I want I'm getting 75 hours well hope to hear from you soon thank you so much sincerely William wible.
PatientReceived no prior treatments
~49 spots leftby Sep 2024