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Completed

NCT Number: NCT00937235

Treatment of Smoking Among Individuals With PTSD

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Varenicline

Drug

1 mg tablets, orally, twice daily x 12 weeks

Other names: Chantix

Medication Management Counseling

Behavioral

15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation

Prolonged Exposure

Behavioral

75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders

Other names: Cognitive-Behavioral Therapy

Primary outcomes

  1. Number of Participants With 7-day Point Prevalence Smoking Abstinence

    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.

Secondary outcomes

  1. Blood Serum Cotinine

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

    Level of cotinine in blood

  2. Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment

    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.

  3. Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up

    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.

  4. Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment

    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.

  5. Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up

    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.

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

    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

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

    Time frame: 3-month follow-up

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2009
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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