Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01393392 · ClinicalTrials.gov registry record · Phase 1
Developing a Smoking Cessation Intervention for Methadone Maintained Smokers
A Phase 1 study, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
NCT01393392: Completed Phase 1 study, sponsored by Rutgers, The State University of New Jersey.
NCT01393392 is a Phase 1 study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 87 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01393392, a Phase 1 study, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
Study Summary
The purpose of this study is to pilot and evaluate, in a randomized controlled trial, the immediate and long-term effects of a newly developed, tailored, intensive smoking cessation intervention among methadone maintained smokers and compared to a control condition (facilitated referral to the NJ Quitline). The newly developed intervention is evidence based, addresses the unique needs of methadone maintained smokers, is intensive, can be tailored to the individual, and builds on the strengths as well as addresses the gaps in previous treatments for methadone maintained smokers. The investigators hypothesize that: (1) three months and six months after beginning treatment, those in the tailored intervention condition will be more likely to be abstinent from smoking than those in the control intervention condition (primary outcome); (2) there will be a greater relapse rate in the control intervention condition between the three and six month follow-up points than in the tailored intervention condition; (3) three and six months after beginning treatment, those in the tailored intervention condition will have better secondary smoking related outcomes (smoked fewer cigarettes per day in the past week, be more ready to quit, have greater self-efficacy for quitting, experience less nicotine dependence, and be more likely to have made a quit attempt) than those in the control intervention condition; (4) three and six months after beginning treatment, those in the tailored intervention condition will have better utilization of and adherence to smoking cessation pharmacotherapy, better mental and physical health, less perceived stress, greater social support, less drug and alcohol use, and greater involvement in drug and alcohol treatment than those in the control intervention condition; and (5) the newly created tailored intervention will be feasible and acceptable. .
Primary Outcome
Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of \<8 parts per million.
Interventions
- BEHAVIORAL Intensive, tailored intervention
- BEHAVIORAL NJ Quitline Referral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01393392 record still lists
NCT01393392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 2 interventions - of which Intensive, tailored intervention is the first listed.
NCT01393392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01393392 about?
NCT01393392 is a clinical study titled "Developing a Smoking Cessation Intervention for Methadone Maintained Smokers". The purpose of this study is to pilot and evaluate, in a randomized controlled trial, the immediate and long-term effects of a newly developed, tailored, intensive smoking cessation intervention among methadone maintained smokers and compared to a control condition (facilitated referral to the NJ Qu...
What is the current status of trial NCT01393392?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 2011-10. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01393392?
The interventions under investigation include: Intensive, tailored intervention (BEHAVIORAL), NJ Quitline Referral (BEHAVIORAL).
Who is sponsoring clinical trial NCT01393392?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01393392's enrollment target sits among peer trials
87 651st of 2000 higher than 1,349 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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
- NCT03292601 · 87 participants · NA
Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)
- NCT04291105 · 87 participants · Phase 2
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
- NCT04565795 · 87 participants · NA
Safety and Device Performance of the Uriprene® Degradable Temporary Ureteral Stent Following Uncomplicated Ureteroscopy
- NCT05607004 · 87 participants · Phase 2
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia