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NCT01615380 · ClinicalTrials.gov registry record · Phase 2
Exercise to Enhance Smoking Cessation for Women at the YMCA
A Phase 2 study, sponsored by The Miriam Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 408
- Enrollment target
NCT01615380: Completed Phase 2 study, sponsored by The Miriam Hospital.
NCT01615380 is a Phase 2 study that has completed, run by The Miriam Hospital. The registered enrollment target is 408 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (207% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01615380, a Phase 2 study, has completed, sponsored by The Miriam Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 408 participants
- Enrollment target
Study Summary
Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be an efficacious treatment component in combating nicotine dependence, especially among women for whom concerns about weight gain during smoking cessation are an obstacle to successful quitting. In previous trials of women smokers, the investigators program of cognitive behavioral smoking cessation treatment (CBT) plus regular aerobic exercise was more efficacious than CBT plus equal contact time. Recognizing the program's successes, Commit to Quit (CTQ) was recently designated an Effective Program by the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Effective Programs. Thus, the Commit to Quit program is well poised for a larger trial in a community setting where it has the potential to reach a large number of female smokers in a setting in which it can be sustained. In response to PA-03-126, Behavioral Therapies Development Program, the investigators propose a Stage III study in which they will conduct a trial to test the investigators CTQ smoking cessation program in the community setting of the local YMCAs. As stated in the PA, Stage III research is aimed at understanding if and how an efficacious therapy may be transported to the community. The investigators propose a randomized controlled clinical trial to take place in the YMCA setting and delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise to CBT smoking cessation treatment plus contact control. In order to promote transportability to the YMCA, the investigators will use the YMCA's existing Personal Fitness Program, which is similar to the investigators CTQ exercise program, in that it is guided by trained staff and requires participants to exercise 3 times per week. If the exercise condition is found to be more efficacious
Primary Outcome
Saliva will be collected at the 12 month follow-up visit and sent to a laboratory for analysis of cotinine, a biomarker of nicotine.
Interventions
- BEHAVIORAL CBT+ Contact
- BEHAVIORAL CBT+ Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2006-09 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT01615380 record still lists
NCT01615380 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (207% higher).
The record links to 0 conditions, and to 2 interventions - of which CBT+ Contact is the first listed.
NCT01615380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01615380 about?
NCT01615380 is a clinical study titled "Exercise to Enhance Smoking Cessation for Women at the YMCA". Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be an efficacious treatment component in combating nicotine dependence, especially among women for whom concerns about...
What is the current status of trial NCT01615380?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 408 participants. The study started on 2006-09. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01615380?
The interventions under investigation include: CBT+ Contact (BEHAVIORAL), CBT+ Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT01615380?
This trial is sponsored by The Miriam Hospital, which has 136 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01615380's enrollment target sits among peer trials
408 93rd of 2000 higher than 1,908 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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