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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00777569
First received: October 21, 2008
Last updated: December 12, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Tobacco Dependence
Drug: Nicotine free cigarettes
Drug: Extra-low nicotine cigarettes
Drug: Nicotine Lozenge
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Study 2: Comparisons of Nicotine-Free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Tobacco Cessation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Nicotine withdrawal symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Motivation to quit and self-efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Perceived risk of PREPS and cigarette evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Compensatory smoking [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 225
Study Start Date: March 2005
Study Completion Date: November 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extra-low nicotine cigarettes Drug: Extra-low nicotine cigarettes
Quest 2 cigarettes contains 0.3 mg nicotine
Experimental: Nicotine-free cigarettes Drug: Nicotine free cigarettes
Quest Step 2 contains 0.05 mg nicotine
Active Comparator: Medicinal Nicotine Drug: Nicotine Lozenge
4 mg nicotine lozenge
Other Name: Commit

Detailed Description:

Smokers (N=150) will be enrolled in the study and will smoke ad libitum for a period of two weeks during which time they will be assessed for baseline measurements. Subjects will then be randomly assigned to one of the three conditions (N=50). Subjects will be blinded as to whether they are assigned to the Quest nicotine-free vs. extra low nicotine condition. There are no distinguishing features between these two cigarettes. Nicotine lozenge assignment is open label. Subjects will be asked to use only their assigned study product (low nicotine, nicotine-free cigarettes or lozenge) for a period of 6 weeks. Study cigarettes will be given to them at each clinic visit and subjects will be told to smoke ad libitum. They will be provided a supply equivalent to 150% of their baseline-smoking rate to allow for compensatory smoking to occur. They will keep record of each cigarette they smoked. If they smoked cigarettes other than those assigned to them, they will be asked to notate on a sheet when that cigarette was smoked. At the end of the 6-week period, they will be asked to quit smoking and NRT.

First morning urine and fasting blood samples will be collected at baseline and 2 and 6 weeks on the study products; at 6 weeks of abstinence and the 1 month follow-up.

Counseling. In each condition, subjects will be provided brief, structured counseling that is similar in duration. The subjects in the cigarette conditions will discuss any difficulties they experienced with switching cigarettes and problem solving these obstacles. Problem solving each obstacle will be solicited from the subject. However, if no solution or limited solution is provided, the counselor will provide a standardized response for each of the obstacles confronted.

Follow-up Phase. Subjects will be followed up 1 month after the end of the 6 week abstinence period.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • unwilling to use study products for 6 weeks;
  • unstable medical or psychiatric condition.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777569

Locations
United States, Minnesota
Univerisity of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
Investigators
Principal Investigator: Dorohty Hatsukami, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dorothy Hatsukami, Ph.D. Principal Investigator, University of Minnesota
ClinicalTrials.gov Identifier: NCT00777569     History of Changes
Other Study ID Numbers: DA 013333
Study First Received: October 21, 2008
Last Updated: December 12, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Smoking
PREPS
Harm reduction
Biomarkers of tobacco exposure
Compensatory smoking

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014