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NCT00777569 · ClinicalTrials.gov registry record · Phase 2
Comparisons of Nicotine-free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine
A Phase 2 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT00777569 is a Phase 2 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 66 participants.
The verdict
NCT00777569, a Phase 2 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study 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.
Interventions
- DRUG Nicotine Lozenge
- DRUG Nicotine free cigarettes
- DRUG Extra-low nicotine cigarettes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2005-03 |
| Est. Completion | 2006-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00777569
The ClinicalTrials.gov registry entry for NCT00777569 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nicotine Lozenge is the first listed.
NCT00777569 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00777569 about?
NCT00777569 is a clinical study titled "Comparisons of Nicotine-free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine". 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...
What is the current status of trial NCT00777569?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2005-03. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00777569?
The interventions under investigation include: Nicotine Lozenge (DRUG), Nicotine free cigarettes (DRUG), Extra-low nicotine cigarettes (DRUG).
Who is sponsoring clinical trial NCT00777569?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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