Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02232737 · ClinicalTrials.gov registry record · Phase 1
Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders
A Phase 1 study of Tobacco Use Disorder, sponsored by Brown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 775
- Enrollment target
- 2
- Study locations
NCT02232737: Completed Phase 1 study of Tobacco Use Disorder, sponsored by Brown University.
NCT02232737 is a Phase 1 study of Tobacco Use Disorder that has completed, run by Brown University. The registered enrollment target is 775 participants, above the 228-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (240% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02232737, a Phase 1 study of Tobacco Use Disorder, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 775 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Adults with affective disorders 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 affective disorders 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.
Primary Outcome
Participant reported number of cigarettes smoked per day at Week 12
Conditions Studied
Interventions
- OTHER Very low nicotine content cigarettes
Study Locations (2)
Rhode Island
- Brown University - Providence
Vermont
- University of Vermont - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 775 participants |
| Start Date | 2016-10-07 |
| Est. Completion | 2019-01-14 |
| Phase | Phase 1 |
What the finished NCT02232737 record still lists
NCT02232737 is an interventional study that assigns participants to a tested intervention. The registered 775 participants enrollment target is mid-sized for trials with a published cap, above the 228-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (240% higher).
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.
NCT02232737 reports a single indexed study location in Rhode Island, Vermont.
Frequently Asked Questions
What is clinical trial NCT02232737 about?
NCT02232737 is a clinical study titled "Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders". This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Adults with affective disorders are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-rel...
What is the current status of trial NCT02232737?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 775 participants. The study started on 2016-10-07. Estimated completion is 2019-01-14.
What conditions does trial NCT02232737 study?
This clinical trial studies the following conditions: Tobacco Use Disorder.
What interventions are being tested in trial NCT02232737?
The interventions under investigation include: Very low nicotine content cigarettes (OTHER).
Who is sponsoring clinical trial NCT02232737?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02232737 being conducted?
This trial has 2 study locations across Rhode Island, Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tobacco Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02232737's enrollment target sits among peer trials
775 6th of 70 higher than 64 of 70 other Tobacco Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Oral Cannabidiol for Tobacco Cessation
RECRUITING · Phase 1
-
Persistence-Targeted Smoking Cessation
COMPLETED · Phase 1
-
Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals - 3
COMPLETED · Phase 1
-
Lorcaserin for Preventing Weight Gain Among Smokers
COMPLETED · Phase 1
-
Brain Imaging in Tobacco Smokers During a Quit Attempt
COMPLETED · Phase 1
-
Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03460769 · 775 participants
Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)
- NCT06145763 · 776 participants · NA
A Digital Smoking Cessation Intervention for Helping American Indians and Alaska Natives Quit Smoking, IndigeQuit Trial
- NCT05642611 · 777 participants · Phase 3
Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy
- NCT06841679 · 778 participants · Phase 2
Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI