Treatment of Smoking Among Individuals With PTSD
1 other identifier
interventional
142
1 country
1
Brief Summary
This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 8, 2009
CompletedFirst Posted
Study publicly available on registry
July 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
September 7, 2017
CompletedNovember 14, 2017
October 1, 2017
6.9 years
July 8, 2009
March 28, 2017
October 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With 7-day Point Prevalence Smoking Abstinence
Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of \<15ng/ml, and CO \< 10 ppm.
At 3-month follow-up (6-month post-quit day)
Secondary Outcomes (7)
Blood Serum Cotinine
At end of 3-month follow-up
Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment
Post-treatment, occurring 12 weeks after the start of treatment (week 0)
Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up
3-month follow-up
Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment
Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)
Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up
3-month follow-up
- +2 more secondary outcomes
Study Arms (2)
Integrated Treatment
EXPERIMENTALProlonged Exposure + Varenicline + Medication Management Counseling
Varenicline
ACTIVE COMPARATORVarenicline + Medication Management Counseling
Interventions
1 mg tablets, orally, twice daily x 12 weeks
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Eligibility Criteria
You may qualify if:
- Male or female treatment-seeking cigarette smokers between 18-75 years old who smoke an average of ≥10 cigarettes/day during past year;
- 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.
You may not qualify if:
- History of drug or alcohol abuse or dependence in past 3 months or any unwillingness to not smoke marijuana during the first 13 weeks of the study;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
Philadelphia, Pennsylvania, 19104, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
1. PPA verified by CO/cotinine was only assessed at two time-points (post-treatment, and follow-up) 2. medication adherence for varenicline was measured using pill count by the study nurse
Results Point of Contact
- Title
- Dr. Edna Foa
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Edna B Foa, Ph.D.
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2009
First Posted
July 10, 2009
Study Start
January 1, 2009
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
November 14, 2017
Results First Posted
September 7, 2017
Record last verified: 2017-10