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Very Low Nicotine Cigarettes for Tobacco Use Disorder

N/A
Waitlist Available
Led By Andrea Hobkirk, PhD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No quit attempt in prior month and not planning to quit smoking within next 3 months
Smoke >5 cigarettes per day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes in bold from baseline to the 6-week visit.
Awards & highlights

Study Summary

This trial will study if smokers who switch to cigarettes with very low nicotine content will have changes in the brain circuits involved in craving and self-control.

Who is the study for?
This trial is for smokers aged 21-60 who smoke more than 5 cigarettes daily, have not tried to quit in the last month, and don't plan to within the next 3 months. Participants should have a high school education or less, earn under $50k annually, and be able to use Zoom. Pregnant women or those at risk of pregnancy are excluded.Check my eligibility
What is being tested?
The study aims to see if smoking very low nicotine content cigarettes affects brain function related to desire and self-control in dependent smokers compared with normal nicotine content cigarettes.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, changes in smoking habits can lead to withdrawal symptoms such as irritability, cravings, difficulty concentrating, increased appetite, and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have not tried to quit smoking in the past month, and you do not plan to quit within the next 3 months.
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You smoke more than 5 cigarettes every day.
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You must be between 21 and 60 years old.
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You are not pregnant or breastfeeding, and are using birth control to prevent pregnancy during the study.
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You have smoked cigarettes every day for over a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes in bold from baseline to the 6-week visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and changes in bold from baseline to the 6-week visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in blood oxygen level dependent (BOLD) activity collected by fMRI

Side effects data

From 2019 Phase 1 & 2 trial • 775 Patients • NCT02232737
35%
Infections and infestations
31%
Respiratory, thoracic, and mediastinal disorders
25%
Gastrointestinal disorders
23%
General disorders
19%
Nervous system disorders
17%
Musculoskeletal and connective tissue disorders
9%
Surgical and medical procedures
9%
Injury, poisoning, and procedural complications
8%
Vascular disorders
1%
Kidney infection
1%
Sudden onset of chest pain due to not enough blood going to the heart
1%
Anxiety, feelings of dread or danger
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.8 mg Nicotine
0.03 mg Nicotine
0.12 mg Nicotine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Very low nicotine content cigarettesExperimental Treatment1 Intervention
Research cigarettes with very low nicotine content (0.03 mg/cigarette) compared to usual brand cigarettes.
Group II: Normal nicotine content cigarettesPlacebo Group1 Intervention
Research cigarettes with normal nicotine content (0.8 mg/cigarette) similar to usual brand cigarettes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Very low nicotine content cigarettes
2016
Completed Phase 2
~2770

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
489 Previous Clinical Trials
2,798,392 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,643 Total Patients Enrolled
Andrea Hobkirk, PhDPrincipal Investigator - Milton S. Hershey Medical Center
Penn State Geisinger Rehabilitation Center, Penn State Milton S. Hershey Medical Center
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Very low nicotine content cigarettes (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03612960 — N/A
Tobacco Addiction Research Study Groups: Normal nicotine content cigarettes, Very low nicotine content cigarettes
Tobacco Addiction Clinical Trial 2023: Very low nicotine content cigarettes Highlights & Side Effects. Trial Name: NCT03612960 — N/A
Very low nicotine content cigarettes (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03612960 — N/A

Frequently Asked Questions

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

Are minors authorized to participate in this clinical experimentation?

"As per the restrictions, only persons aged 21 to 60 are eligible for enrollment in this clinical trial."

Answered by AI

Is there a possibility for eligible individuals to join this experiment?

"Affirmative. Per information on clinicaltrials.gov, this medical trial is actively recruiting participants; the first listing was made on February 20th 2020 and it has been revised as recently as March 25th 2022. The research team requires a total of 90 individuals to take part in the study from one specific site."

Answered by AI

Who may participate in the current clinical exploration?

"This clinical trial is seeking 90 individuals addicted to tobacco, aged between 21 and 60. There are a number of prerequisites for enrolment, such as smoking at least 5 cigarettes daily; residing in the local vicinity for 3 months; 1 year or more of nicotine usage without cessation attempts; comprehending and consenting to research protocols; abstaining from pregnancy/nursing via contraception measures; access to an internet-enabled computer with Zoom capabilities; having no higher than high school education or earning less than $50k annually. In addition, applicants must not have attempted quitting within 1 month prior nor plan on doing so over the following 3 months"

Answered by AI

What is the capacity of enrollment in this clinical trial?

"Affirmative. The clinical trial, which was initially advertised on February 20th 2020, is still recruiting patients as per the information hosted on clinicaltrials.gov and last updated on March 25th 2022. They are looking for 90 participants to enroll at one location."

Answered by AI

What other experimentations have been conducted using Very low nicotine content cigarettes?

"As of now, 71 clinical trials for Very low nicotine content cigarettes are being conducted. Of those, 5 have reached the third phase of study. The majority of these research sites are based in Greenville, South carolina; however there is a total number of 204 locations managing experiments related to this treatment."

Answered by AI
~8 spots leftby Mar 2025