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Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
NCT02250664 · View on ClinicalTrials.gov ↗
Study Summary
This study will examine extended exposure to cigarettes varying in nicotine content among adults with opioid use disorder. Those with opioid use disorder are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health consequences, including site specific cancers, heart disease, and premature death. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like those with opioid use disorder who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap. This same study was also conducted in two additional vulnerable populations under a similar protocol.
Conditions Studied
Interventions
- OTHER Very low nicotine content cigarettes
Study Locations (2)
Maryland
- Johns Hopkins University — Baltimore
Vermont
- University of Vermont — Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 775 participants |
| Start Date | 2016-10 |
| Est. Completion | 2019-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02250664
The ClinicalTrials.gov registry entry for NCT02250664 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 775 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 107 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Tobacco Use Disorder appearing as the primary indexed condition, and to 1 intervention — of which Very low nicotine content cigarettes is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02250664 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Maryland, Vermont. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02250664 about?
NCT02250664 is a clinical study titled "Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers". This study will examine extended exposure to cigarettes varying in nicotine content among adults with opioid use disorder. Those with opioid use disorder are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for ...
What is the current status of trial NCT02250664?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 775 participants. The study started on 2016-10. Estimated completion is 2019-10.
What conditions does trial NCT02250664 study?
This clinical trial studies the following conditions: Tobacco Use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02250664?
The interventions under investigation include: Very low nicotine content cigarettes (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02250664?
This trial is sponsored by University of Vermont, which has 107 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02250664 being conducted?
This trial has 2 study locations across Maryland, Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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