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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 is a Phase 1 study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 87 participants.
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. .
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01393392
The ClinicalTrials.gov registry entry for NCT01393392 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intensive, tailored intervention is the first listed.
NCT01393392 reports 0 study locations.
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.
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