Very low nicotine content cigarettes for Tobacco Addiction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Penn State Health, Hershey, PATobacco AddictionVery low nicotine content cigarettes - Drug
Eligibility
21 - 60
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Tobacco Addiction

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Changes in BOLD from baseline to the 6-week visit.

Changes in BOLD from baseline to the 6-week visit.
Changes in blood oxygen level dependent (BOLD) activity collected by fMRI

Trial Safety

Side Effects for

0.03 mg Nicotine
32%Infections and infestations
29%Respiratory, thoracic, and mediastinal disorders
27%Gastrointestinal disorders
23%General disorders
16%Nervous system disorders
12%Musculoskeletal and connective tissue disorders
9%Surgical and medical procedures
9%Vascular disorders
6%Injury, poisoning, and procedural complications
1%Broken bone
1%Seizure
1%Anxiety, feelings of dread or danger
This histogram enumerates side effects from a completed 2019 Phase 1 & 2 trial (NCT02232737) in the 0.03 mg Nicotine ARM group. Side effects include: Infections and infestations with 32%, Respiratory, thoracic, and mediastinal disorders with 29%, Gastrointestinal disorders with 27%, General disorders with 23%, Nervous system disorders with 16%.

Trial Design

2 Treatment Groups

Very low nicotine content cigarettes
1 of 2
Normal nicotine content cigarettes
1 of 2

Experimental Treatment

Non-Treatment Group

90 Total Participants · 2 Treatment Groups

Primary Treatment: Very low nicotine content cigarettes · Has Placebo Group · Phase < 1

Very low nicotine content cigarettes
Drug
Experimental Group · 1 Intervention: Very low nicotine content cigarettes · Intervention Types: Drug
Normal nicotine content cigarettes
Drug
PlaceboComparator Group · 1 Intervention: Normal nicotine content cigarettes · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: changes in bold from baseline to the 6-week visit.

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
466 Previous Clinical Trials
2,785,744 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

Eligibility Criteria

Age 21 - 60 · All Participants · 10 Total Inclusion Criteria

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

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - 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.