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Treatment of Smoking Among Individuals With PTSD

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ClinicalTrials.gov Identifier: NCT00937235
Recruitment Status : Completed
First Posted : July 10, 2009
Results First Posted : September 7, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

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.


Condition or disease Intervention/treatment Phase
Cigarette Smoking Nicotine Dependence Post-traumatic Stress Disorder Tobacco Use Disorder Drug: Varenicline Behavioral: Medication Management Counseling Behavioral: Prolonged Exposure Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
Study Start Date : January 2009
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Integrated Treatment
Prolonged Exposure + Varenicline + Medication Management Counseling
Drug: Varenicline
1 mg tablets, orally, twice daily x 12 weeks
Other Name: Chantix
Behavioral: Medication Management Counseling
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
Behavioral: Prolonged Exposure
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Other Name: Cognitive-Behavioral Therapy
Active Comparator: Varenicline
Varenicline + Medication Management Counseling
Drug: Varenicline
1 mg tablets, orally, twice daily x 12 weeks
Other Name: Chantix
Behavioral: Medication Management Counseling
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937235


Locations
United States, Pennsylvania
University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Edna B Foa, Ph.D. University of Pennsylvania

Additional Information:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00937235     History of Changes
Other Study ID Numbers: R01DA023507 ( U.S. NIH Grant/Contract )
R01DA023507 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2009    Key Record Dates
Results First Posted: September 7, 2017
Last Update Posted: November 14, 2017
Last Verified: October 2017

Keywords provided by University of Pennsylvania:
Smoking Cessation
Anxiety
Behavior Therapy
Varenicline

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Tobacco Use Disorder
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs