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Antidepressant
Tailored intervention for Nicotine Addiction
Phase 3
Waitlist Available
Led By Mark W. Vander Weg, Ph.D.
Research Sponsored by Mark Vander Weg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six-month follow-up
Awards & highlights
Study Summary
The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.
Eligible Conditions
- Nicotine Addiction
- Tobacco Use
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tobacco use
Secondary outcome measures
Alcohol use
Body weight
Depressive symptoms
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tailored interventionExperimental Treatment12 Interventions
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
Group II: Enhanced standard of careActive Control9 Interventions
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupropion
FDA approved
Varenicline
FDA approved
Tailored behavioral intervention
2012
Completed Phase 2
~70
Alcohol use risk reduction
2012
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentFED
1,612 Previous Clinical Trials
3,305,332 Total Patients Enrolled
Mark Vander WegLead Sponsor
2 Previous Clinical Trials
262 Total Patients Enrolled
Mark W. Vander Weg, Ph.D.Principal InvestigatorVRHRC-CR
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