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NCT01199380 · ClinicalTrials.gov registry record · Phase 2
Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms
A Phase 2 study, sponsored by University of Maryland, College Park.
- Completed
- Registry status
- Phase 2
- Development phase
- 184
- Enrollment target
NCT01199380: Completed Phase 2 study, sponsored by University of Maryland, College Park.
NCT01199380 is a Phase 2 study that has completed, run by University of Maryland, College Park. The registered enrollment target is 184 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01199380, a Phase 2 study, has completed, sponsored by University of Maryland, College Park.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 184 participants
- Enrollment target
Study Summary
Depression related vulnerabilities are highly comorbid with smoking behavior and dramatically reduce cessation rates among both community and clinical samples. Previous research has examined the efficacy of cognitive-behavioral treatment for individuals with a history of major depressive disorder (MDD) in standard cessation treatment. A broader health impact can be achieved by targeting individuals with current elevated depressive symptoms to address their association with cessation failure. Thus the objective of the present proposal is to conduct a Stage II randomized controlled trial (RCT) comparing the behavioral activation intervention to standard treatment among a similar community sample of 200 adult smokers with elevated depressive symptoms. Participants will be followed over 52 weeks post-quit date and the larger sample size will allow for more complex analysis of cessation outcomes.
Primary Outcome
7 days of smoking abstinence confirmed biochemically at 52 week post quit attempt
Interventions
- DRUG Transdermal Nicotine Patch
- BEHAVIORAL Standard Treatment
- BEHAVIORAL Behavioral Activation Treatment for Smoking
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2010-09 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT01199380 record still lists
NCT01199380 is an interventional study that assigns participants to a tested intervention. The registered 184 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 (38% higher).
The record links to 0 conditions, and to 3 interventions - of which Transdermal Nicotine Patch is the first listed.
NCT01199380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01199380 about?
NCT01199380 is a clinical study titled "Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms". Depression related vulnerabilities are highly comorbid with smoking behavior and dramatically reduce cessation rates among both community and clinical samples. Previous research has examined the efficacy of cognitive-behavioral treatment for individuals with a history of major depressive disorder (M...
What is the current status of trial NCT01199380?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 184 participants. The study started on 2010-09. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01199380?
The interventions under investigation include: Transdermal Nicotine Patch (DRUG), Standard Treatment (BEHAVIORAL), Behavioral Activation Treatment for Smoking (BEHAVIORAL).
Who is sponsoring clinical trial NCT01199380?
This trial is sponsored by University of Maryland, College Park, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01199380's enrollment target sits among peer trials
184 360th of 2000 higher than 1,638 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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