Normal Nicotine Content research cigarettes for Tobacco Addiction

Penn State College of Medicine, Hershey, PA
Tobacco AddictionNormal Nicotine Content research cigarettes - Other
Eligibility
21 - 70
All Sexes

Study Summary

This trial will test if cigarettes with very low nicotine levels, along with e-cigs, help smokers with mental health conditions quit smoking.

Eligible Conditions
  • Tobacco Addiction

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Week 20

Week 16
Exhaled Carbon Monoxide
Kessler-6 score
Penn State Cigarette Dependence Index
Penn State Electronic Cigarette Dependence Index
Urinary NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol)
Week 20
Cigarette abstinence

Trial Safety

Phase-Based Safety

1 of 3

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1
Research Cigarettes (SPECTRUM)
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

NNC cigarettes + Zero Nicotine Containing E-cigarette
1 of 4
NNC cigarettes + High Nicotine Containing E-cigarette
1 of 4
VLNC cigarettes + High Nicotine Containing E-cigarette
1 of 4
VLNC cigarettes + Zero Nicotine Containing E-cigarette
1 of 4

Experimental Treatment

240 Total Participants · 4 Treatment Groups

Primary Treatment: Normal Nicotine Content research cigarettes · No Placebo Group · N/A

NNC cigarettes + Zero Nicotine Containing E-cigaretteExperimental Group · 2 Interventions: Normal Nicotine Content research cigarettes, Zero Nicotine e-cigarette · Intervention Types: Other, Other
NNC cigarettes + High Nicotine Containing E-cigaretteExperimental Group · 2 Interventions: Normal Nicotine Content research cigarettes, High Nicotine e-cigarette · Intervention Types: Other, Other
VLNC cigarettes + High Nicotine Containing E-cigaretteExperimental Group · 2 Interventions: High Nicotine e-cigarette, Very Low Nicotine Content research cigarettes · Intervention Types: Other, Other
VLNC cigarettes + Zero Nicotine Containing E-cigaretteExperimental Group · 2 Interventions: Zero Nicotine e-cigarette, Very Low Nicotine Content research cigarettes · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 20

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
469 Previous Clinical Trials
2,785,767 Total Patients Enrolled
Jonathan Foulds, PhDPrincipal Investigator - Penn State College of Medicine
Milton S. Hershey Medical Center
3 Previous Clinical Trials
307 Total Patients Enrolled

Eligibility Criteria

Age 21 - 70 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not tried to quit smoking or used any medication to quit smoking in the last 30 days.
You must be willing to try smoking a different type of cigarette with varying nicotine levels and to try using an electronic cigarette to replace some of your regular cigarettes.
You have been diagnosed with a mood disorder (such as depression or bipolar disorder), an anxiety disorder (such as panic disorder or PTSD), a psychotic disorder, or an eating disorder by a healthcare provider using a specific set of criteria.
You smoke more than 5 cigarettes every day for the past year.
You smoke regular or filtered cigarettes, or cigarettes made by a machine that has a filter.
You do not plan to stop smoking for at least 3 weeks.

Who else is applying?

What state do they live in?
Virginia100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "I have tried for years to quit smoking but cant because of the medications offered are not good for someone who is severely bipolar like I am"
What questions have other patients asked about this trial?
  • "Will I be able to do most of the trial virtually?"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

To what extent is the study recruiting participants?

"Affirmative, according to the clinicaltrials.gov database this research is still on-going and actively recruiting individuals for participation. The project was initially listed on June 1st 2021 with a most recent update taking place July 14th 2022. 240 participants are needed at one designated location." - Anonymous Online Contributor

Unverified Answer

Is this study open to new participants at the moment?

"Affirmative, clinicaltrials.gov confirms that this clinical trial is proactively searching for participants and has been doing so since the June 1st 2021 launch date. Approximately 240 patients have to be enrolled from one medical location before data collection can commence." - Anonymous Online Contributor

Unverified Answer

Does the trial require participants to exceed a certain age threshold?

"This clinical trial is targeting participants aged 21-70, although there are separate studies for individuals under 18 and those over 65." - Anonymous Online Contributor

Unverified Answer

Am I eligible to be a part of this clinical trial?

"This clinical study is open to a total of 240 individuals aged 21 and 70, who suffer from nicotine dependence. Prospective participants must satisfy the following criteria: be amenable towards using an e-cigarette or different strength cigarettes; have not attempted cigarette cessation in the last month nor plan on quitting within 3 weeks; possess no intentions for relocating away or taking extended vacations during trial period; meet lifetime diagnostic requirements for mood/anxiety/psychotic disorder as determined by MINI International Neuropsychiatric Interview Standard (version 7.0.2); smoke more than 5 daily filtered cigarettes with filter over 12 months prior." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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