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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 is a Phase 2 study that has completed, run by University of Maryland, College Park. The registered enrollment target is 184 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01199380
The ClinicalTrials.gov registry entry for NCT01199380 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, College Park, which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Transdermal Nicotine Patch is the first listed.
NCT01199380 reports 0 study locations.
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.
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