Treatment of Smoking Among Individuals With PTSD

• 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: University of Pennsylvania
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): University of Pennsylvania

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• 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.

Contacts and Locations

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

More Information

Additional Information:

Center for the Treatment and Study of Anxiety 

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00937235
• Other Study ID Numbers: R01DA023507 ( U.S. NIH Grant/Contract ); R01DA023507 ( U.S. NIH Grant/Contract )
• First Posted: July 10, 2009
• 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; Tobacco Use Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; 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