University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT00937235
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Philadelphia, Pennsylvania, 19104, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 mg tablets, orally, twice daily x 12 weeks
Other names: Chantix
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
Other names: Cognitive-Behavioral Therapy
Time frame: At 3-month follow-up (6-month post-quit day)
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.
Time frame: At end of 3-month follow-up
Level of cotinine in blood
Time frame: Post-treatment, occurring 12 weeks after the start of treatment (week 0)
Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.
Higher scores indicate higher/worse levels of PTSD.
Time frame: 3-month follow-up
Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.
Higher scores indicate higher/worse levels of PTSD.
Time frame: Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)
Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.
Higher scores indicate higher/worse levels of depression.
Time frame: 3-month follow-up
Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.
Higher scores indicate higher/worse levels of depression.
Time frame: Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit
Time frame: 3-month follow-up
Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit
University of Pennsylvania
Other
Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
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