Innovative Interventions for Smoking Cessation

Tobacco Use Disorder Clinical Trial

Official title:

Innovative Interventions for Smoking Cessation: Comparison of Very Low Nicotine Content Cigarettes Plus Nicotine Patch; Very Low Nicotine Content Cigarettes Alone or Nicotine Patch Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050569
• Other study ID #: 0409M63686
• Secondary ID: 1R01DA025598
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: June 2012

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

Description:

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.

The following primary hypothesis will be tested:

Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.

Other hypotheses include:

1. Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;

2. Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and

3. Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.

Cigarette smokers will be randomized to:

1. VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;

2. Nicotine patch for 6 weeks; or

3. VLNC cigarettes alone.

Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• a) Smoking at least 10 cigarettes daily for the past year;

• b) In good physical health;

• c) No contraindications for medicinal nicotine; and

• d) Stable, good mental health.

Exclusion Criteria:

• a) Subjects must not be using other tobacco or nicotine products.

• b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Nicotine Patch
21 mg

Other:
• VLNC Cigarette
Cigarette where the tobacco contains <0.1 mg of nicotine yield.
• VLNC Cigarette Plus Nicotine Patch
21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.

Locations

Country	Name	City	State
United States	University of Minnesota	Duluth	Minnesota
United States	University of MN's Tobacco Use Research Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hatsukami DK, Hertsgaard LA, Vogel RI, Jensen JA, Murphy SE, Hecht SS, Carmella SG, al'Absi M, Joseph AM, Allen SS. Reduced nicotine content cigarettes and nicotine patch. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1015-24. doi: 10.1158/1055-9965.EP — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of Treatment Abstinence Rate	Cotinine and carbon monoxide (CO) verified point prevalence abstinence	12 week
Primary	End of Follow-up Abstinence Rates	CO- and cotinine-verified point prevalence abstinence	36 weeks
Secondary	Exposure to Tobacco Toxicants		6 weeks
Secondary	Time to Lapse or Relapse to Tobacco Use		26 weeks