Cigarette Smoking Clinical Trial
Official title:
Stage II Trial of Novel Behavioral Activation Intervention for Smoking Cessation
Verified date | May 2022 |
Source | University of Maryland, College Park |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 184 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Between 18 and 65 years of age - A regular smoker for at least one year - Currently smoking an average of at least 10 cigarettes per day - Want to quit smoking - Report current elevated depressive symptoms Exclusion Criteria: - Current Axis I disorder - Psychoactive substance dependence (excluding nicotine dependence) within the past 6 months - Current use of psychotropic medication or participation in any form of psychotherapy - A history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness - Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland, College Park | College Park | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, College Park | National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Smoking-Abstinent for 7 Days, 52 Weeks Post Quit Date | 7 days of smoking abstinence confirmed biochemically at 52 week post quit attempt | 52 weeks post quit date |
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