Clinical trial NCT00937235: Treatment of Smoking Among Individuals With PTSD
Official title: Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cigarette Smoking
Nicotine Dependence
Post-traumatic Stress Disorder
Tobacco Use Disorder
Keywords: Smoking Cessation
Anxiety
Behavior Therapy
Varenicline
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-07-10
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With 7-day Point Prevalence Smoking Abstinence
timeFrame: At 3-month follow-up (6-month post-quit day)
Secondary outcomes:
measure: Blood Serum Cotinine
timeFrame: At end of 3-month follow-up
measure: Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment
timeFrame: Post-treatment, occurring 12 weeks after the start of treatment (week 0)
measure: Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up
timeFrame: 3-month follow-up
measure: Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment
timeFrame: Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)
measure: Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up
timeFrame: 3-month follow-up
measure: TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)
timeFrame: Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
measure: TLFB - Cigarettes Smoked Week Before 3-Month Follow-up
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Edna B Foa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: