Treatment of Smoking Among Individuals With PTSD

University of Pennsylvania142 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

142

Conditions

Cigarette Smoking Nicotine Dependence Post-traumatic Stress Disorder Tobacco Use Disorder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: At 3-month follow-up (6-month post-quit day)

Secondary Outcomes

Blood Serum Cotinine

Level of cotinine in blood

Time frame: At end of 3-month follow-up

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.

Time frame: 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

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: 3-month follow-up

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.

Time frame: 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

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: 3-month follow-up

TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)

Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit

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

TLFB - Cigarettes Smoked Week Before 3-Month Follow-up

Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit

Time frame: 3-month follow-up

Treatment of Smoking Among Individuals With PTSD

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes