Treatment of Smoking Among Individuals With PTSD

Nicotine Dependence Clinical Trial

Official title:

Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937235
• Other study ID #: R01DA023507
• Secondary ID: R01DA023507
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2009
• Last updated: October 11, 2017
• Start date: January 2009
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Smoking
• Disease
• Nicotine Dependence
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Tobacco Use Disorder

Intervention

Drug:
• Varenicline
1 mg tablets, orally, twice daily x 12 weeks

Behavioral:
• 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

Locations

Country	Name	City	State
United States	University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood Serum Cotinine	Level of cotinine in blood	At end of 3-month follow-up
Secondary	Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment	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.	Post-treatment, occurring 12 weeks after the start of treatment (week 0)
Secondary	Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 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.	3-month follow-up
Secondary	Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment	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.	Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)
Secondary	Hamilton Depression Scale (HAM-D) Total Score at 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.	3-month follow-up
Secondary	TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)	Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit	Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
Secondary	TLFB - Cigarettes Smoked Week Before 3-Month Follow-up	Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit	3-month follow-up

External Links

•   Center for the Treatment and Study of Anxiety