Treatment of Smoking Among Individuals With PTSD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00937235
First received: July 8, 2009
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 7-day point prevalence smoking abstinence [ Time Frame: End of treatment and 6-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prolonged smoking abstinence [ Time Frame: End of treatment and 6-month follow-up ] [ Designated as safety issue: No ]
  • Continuous smoking abstinence [ Time Frame: End of treatment and 6-month follow-up ] [ Designated as safety issue: No ]
  • Days to smoking relapse [ Time Frame: End of treatment and 6-month follow-up ] [ Designated as safety issue: No ]
  • Decrease in number of cigarettes smoked/day [ Time Frame: End of treatment and 6-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 166
Study Start Date: January 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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);
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937235

Contacts
Contact: Edna B Foa, Ph.D. 215-746-3327 foa@mail.med.upenn.edu
Contact: Seth J Gillihan, Ph.D. 215-746-3327 gillihan@mail.med.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Edna B Foa, Ph.D.    215-746-3327    foa@mail.med.upenn.edu   
Contact: Seth J Gillihan, Ph.D.    215-746-3327    gillihan@mail.med.upenn.edu   
Principal Investigator: Edna B Foa, Ph.D.         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Edna B Foa, Ph.D. University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Edna B. Foa, Ph.D.,, University of Pennsylvania School of Medicine, Dept. of Psychiatry
ClinicalTrials.gov Identifier: NCT00937235     History of Changes
Other Study ID Numbers: R01DA023507, R01DA023507
Study First Received: July 8, 2009
Last Updated: February 23, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 16, 2014