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NCT01989507 · ClinicalTrials.gov registry record · Phase 2
Very Low-Nicotine Cigarettes in Smokers With SUD
A Phase 2 study, sponsored by Brown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT01989507 is a Phase 2 study that has completed, run by Brown University. The registered enrollment target is 250 participants.
The verdict
NCT01989507, a Phase 2 study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy, acceptability and unintended consequences of very low nicotine content cigarettes (VLNCC) in smokers with current or past year substance use disorders (SUD). The primary aim of this study is to determine whether 6 weeks of VLNCC compared to normal nicotine content cigarettes (NNCC) will result in more smoking cessation over 6 months and reduce cigarette use, cotinine, and biomarkers of toxicity. We will also assess the effects of VLNCC versus NNCC cigarettes on frequency of substance use and substance cravings (drugs and alcohol) because this is relevant to the safety of these products among smokers with SUD. Secondary aims are to study effects on cigarette craving, nicotine withdrawal and dependence, and depressed mood. Methods: Random assignment to VLNCC versus NNCC of up to 312 smokers with SUD will be balanced by gender, degree of tobacco dependence, and recent drug and alcohol use. All smokers will be provided with smoking counseling. Assessments over 6 months will assess effects both during the 6 weeks of using research cigarettes and after return to usual cigarettes. The importance is in determining the viability and safety of this public health strategy in terms of effects on both smoking and other substance use in a highly addicted population, which is essential to determine before the FDA implements this policy.
Interventions
- DRUG Nicotine
- BEHAVIORAL behavioral counseling for smoking cessation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2014-04 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01989507
The ClinicalTrials.gov registry entry for NCT01989507 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nicotine is the first listed.
NCT01989507 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01989507 about?
NCT01989507 is a clinical study titled "Very Low-Nicotine Cigarettes in Smokers With SUD". The purpose of this study is to determine the efficacy, acceptability and unintended consequences of very low nicotine content cigarettes (VLNCC) in smokers with current or past year substance use disorders (SUD). The primary aim of this study is to determine whether 6 weeks of VLNCC compared to nor...
What is the current status of trial NCT01989507?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2014-04. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT01989507?
The interventions under investigation include: Nicotine (DRUG), behavioral counseling for smoking cessation (BEHAVIORAL).
Who is sponsoring clinical trial NCT01989507?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
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