Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2009-01-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Integrated Treatment
Prolonged Exposure + Varenicline + Medication Management Counseling
Varenicline
1 mg tablets, orally, twice daily x 12 weeks
Medication Management Counseling
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
Prolonged Exposure
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Varenicline
Varenicline + Medication Management Counseling
Varenicline
1 mg tablets, orally, twice daily x 12 weeks
Medication Management Counseling
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Varenicline
1 mg tablets, orally, twice daily x 12 weeks
Medication Management Counseling
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
Prolonged Exposure
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Current diagnosis of chronic PTSD (symptom duration \> 3 months) with clinically significant trauma-related symptoms (PSS-I \>= 20)
* Live a commutable distance to the University of Pennsylvania and agree to follow-up visits;
* Agree not to use other forms of smoking cessation treatment or treatment for PTSD during the study period;
* If taking SRIs or other medications at intake, have been on stable medication and dose regimen for past 3 months and agree to maintain current regimen if possible;
* Demonstrate the capacity to provide informed consent;
* Speak and read English.
Exclusion Criteria
* Current and continuing intimate relationship with a physically or sexually abusive partner;
* Current suicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment;
* Prior serious suicide attempt, as judged by the evaluator to have a high degree of lethality;
* Current or past history of psychosis (bipolar disorder or schizophrenia);
* History of significant cardiovascular disease or uncontrolled hypertension in past 6 months;
* Women who are pregnant, likely to become pregnant (i.e., sexually active and not using contraception), or nursing.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edna B Foa, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Center for the Treatment and Study of Anxiety