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Treatment of Smoking Among Individuals With PTSD

Primary Purpose

Cigarette Smoking, Nicotine Dependence, Post-traumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Medication Management Counseling
Prolonged Exposure
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cigarette Smoking focused on measuring Smoking Cessation, Anxiety, Behavior Therapy, Varenicline

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated Treatment

Varenicline

Arm Description

Prolonged Exposure + Varenicline + Medication Management Counseling

Varenicline + Medication Management Counseling

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Blood Serum Cotinine
Level of cotinine in blood
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.
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.
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.
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.
TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)
Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit
TLFB - Cigarettes Smoked Week Before 3-Month Follow-up
Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit

Full Information

First Posted
July 8, 2009
Last Updated
October 11, 2017
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00937235
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Nicotine Dependence, Post-traumatic Stress Disorder, Tobacco Use Disorder
Keywords
Smoking Cessation, Anxiety, Behavior Therapy, Varenicline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Treatment
Arm Type
Experimental
Arm Description
Prolonged Exposure + Varenicline + Medication Management Counseling
Arm Title
Varenicline
Arm Type
Active Comparator
Arm Description
Varenicline + Medication Management Counseling
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
1 mg tablets, orally, twice daily x 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Medication Management Counseling
Intervention Description
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure
Other Intervention Name(s)
Cognitive-Behavioral Therapy
Intervention Description
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Primary Outcome Measure Information:
Title
Number of Participants With 7-day Point Prevalence Smoking Abstinence
Description
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 Outcome Measure Information:
Title
Blood Serum Cotinine
Description
Level of cotinine in blood
Time Frame
At end of 3-month follow-up
Title
Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment
Description
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)
Title
Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up
Description
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
Title
Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment
Description
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)
Title
Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up
Description
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
Title
TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)
Description
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
Title
TLFB - Cigarettes Smoked Week Before 3-Month Follow-up
Description
Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit
Time Frame
3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edna B Foa, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.med.upenn.edu/ctsa/
Description
Center for the Treatment and Study of Anxiety

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Treatment of Smoking Among Individuals With PTSD

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