Comparisons of Nicotine-free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine

NCT00777569 | Completed Phase 2 DMC

• 1 other identifier: DA 013333
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, smokers will be randomly assigned to one of three conditions for six weeks: 1) nicotine-free cigarettes (0.05mg); 2) extra low nicotine cigarettes (0.3 mg); or 3) medicinal 4 mg nicotine lozenge. The tobacco toxin profiles across these various products will be compared. The effects of these products on biomarkers of exposure and risk factors for disease, compensatory smoking, components of tobacco addiction and short-term smoking cessation will be determined. Predictors of response to these products (e.g., compensatory smoking, compliance with product use, time to lapse) will also be examined. The following primary hypothesis will be tested: 1) Extent of tobacco toxin exposure will be greatest for the extra low nicotine cigarette and least for nicotine lozenge. Other secondary hypotheses include: 2) Compensatory smoking, as calculated by using cotinine, will be greatest for the extra low cigarette compared to the nicotine-free cigarette; 3) Greater positive subjective responses to cigarettes will be observed with extra low nicotine vs. nicotine-free cigarette; 4) Similar withdrawal symptoms and negative affect will be observed with nicotine-free cigarette and nicotine lozenge, and least withdrawal and negative affect with the extra low nicotine cigarette; 6) Least dependence and greatest motivation and self-efficacy to quit will be observed with nicotine lozenge and the greatest dependence and least motivation and self-efficacy to quit with the extra low nicotine cigarette use; 7) Shorter time to lapse will be observed with extra low nicotine vs. nicotine-free cigarettes because of extinction is likely to occur with nicotine-free cigarettes, and the longest time to lapse for nicotine lozenge because the cigarette condition groups will have experienced stronger attentional bias toward cues, and more dependence prior to the quit date and greater withdrawal after the quit date.

Conditions

Tobacco Dependence

Keywords

Smoking; PREPS; Harm reduction; Biomarkers of tobacco exposure; Compensatory smoking

Outcome Measures

Primary Outcomes (2)

• Biomarkers for tobacco exposure measures: Carbon monoxide, cotinine, NNAL-gluc, NNN, mercapturic acids, 1-hydroxypytrene and biomarkers for cardiovascular risk: WBC, lipid profile, fibrinogen, heart rate, blood pressure.

  6 weeks

• Tobacco Cessation

  12 weeks

Secondary Outcomes (5)

• Pulmonary function

  12 weeks

• Nicotine withdrawal symptoms

  12 weeks

• Motivation to quit and self-efficacy

  12 weeks

• Perceived risk of PREPS and cigarette evaluation

  12 weeks

• Compensatory smoking

  6 weeks

Study Arms (3)

Extra-low nicotine cigarettes

EXPERIMENTAL

Drug: Extra-low nicotine cigarettes

Nicotine-free cigarettes

EXPERIMENTAL

Drug: Nicotine free cigarettes

Medicinal Nicotine

ACTIVE COMPARATOR

Drug: Nicotine Lozenge

Interventions

Nicotine free cigarettes DRUG

Quest Step 2 contains 0.05 mg nicotine

Nicotine-free cigarettes

Extra-low nicotine cigarettes DRUG

Quest 2 cigarettes contains 0.3 mg nicotine

Extra-low nicotine cigarettes

Nicotine Lozenge DRUG

4 mg nicotine lozenge

Also known as: Commit

Medicinal Nicotine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smoking between 10-40 cigarettes daily for the past year;
• in good physical health (no unstable medical condition;
• no contraindications for medicinal nicotine;
• stable, good mental health

You may not qualify if:

• unwilling to use study products for 6 weeks;
• unstable medical or psychiatric condition.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Univerisity of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (2)

• Dermody SS, Donny EC, Hertsgaard LA, Hatsukami DK. Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. Tob Control. 2015 Nov;24(6):536-9. doi: 10.1136/tobaccocontrol-2014-051797. Epub 2014 Sep 5.

  PMID: 25192771 DERIVED

• Hatsukami DK, Kotlyar M, Hertsgaard LA, Zhang Y, Carmella SG, Jensen JA, Allen SS, Shields PG, Murphy SE, Stepanov I, Hecht SS. Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction. 2010 Feb;105(2):343-55. doi: 10.1111/j.1360-0443.2009.02780.x.

  PMID: 20078491 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Harm Reduction

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Dorohty Hatsukami, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: March 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: November 1, 2006
• Last Updated: January 16, 2017

Record last verified: 2008-12

Locations

US (1)