22nd Century Group Inc (XXII)

[Bubbster]

Clinical Study Info

I was trying to piece together comprehensive data out of the articles being put out recently, most of which seemed (to me) lacking bits of information. Anyway, scrunching about the web I compiled the below info and time lines.

ClinicalTrials.gov Identifier: NCT01681875
First received: August 30, 2012
Last updated: September 17, 2014
Last verified: September 2014
Study Status: This study has been completed.
Study Completion Date: July 2014

This appears to be the study that made it into the NEJM on 10/1/15
http://www.nejm.org/doi/full/10.1056/NEJMsa1502403#t=articleResults

In the last paragraph, in part, under “Discussion”
“If confirmed in longer-term studies, these findings suggest that, when combined with other tobacco-control policies (e.g., taxation and expanded access to treatment), limiting the nicotine content of cigarettes in order to reduce cigarette use and nicotine dependence and facilitate efforts to quit smoking could improve public health.”

“A longer trial is currently under way (ClinicalTrials.gov number, NCT02139930) “
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From: ClinicalTrials.gov
ClinicalTrials.gov Identifier: NCT02139930
First received: May 12, 2014
Last updated: May 26, 2015
This was added 5-12-15: Grant/Contract Award
Last verified: May 2015

This study is currently recruiting participants.
Verified May 2015 by University of Pittsburgh

Sponsor: University of Pittsburgh
Collaborator: National Institute on Drug Abuse (NIDA)

Estimated Enrollment: 1250
Study Start Date: September 2014
Estimated Study Completion Date: August 2016

"The main goal of this project is to compare two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels or a gradual reduction in nicotine content in cigarettes to non-addictive levels. These two approaches will then be contrasted to a group that continues to smoke cigarettes with nicotine content similar to conventional cigarettes."

Listed as “Arms”
Active Comparator: Normal Nicotine Control Group
These subject will smoke normal nicotine content Spectrum brand cigarettes for 20 weeks.

Experimental: Immediate Nicotine Reduction Group
This group will immediately be switched to smoking very low nicotine content (VLNC) Spectrum brand cigarettes. They will smoke these cigarettes for 20 weeks.

Experimental: Gradual Nicotine Reduction Group
This group will smoke progressively lower nicotine content Spectrum brand cigarettes for a period of one month each until the end up smoking the same VLNC cigarettes as the immediate reduction group.
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“September 1, 2015….22nd Century Group, Inc., announced today that its wholly-owned subsidiary, Goodrich Tobacco Company, received a purchase order for 4.95 million SPECTRUM U.S. government research cigarettes.”
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Not stated,but seems that this would fit in for ClinicalTrials.gov Identifier: NCT02139930

Comments ?