CPT-SMART for Treatment of PTSD and Cigarette Smoking

MHBB-008-18F

Smoking is the leading cause of preventable illness, disability, and death in the United States. The rate of smoking is disproportionately higher among Veterans with posttraumatic stress disorder (PTSD). Unfortunately, smoking cessation efforts that are effective in the general population have shown limited effectiveness in smokers with PTSD. The high smoking rate and difficulty with achieving abstinence indicate a critical need to develop effective interventions for Veterans who smoke and have PTSD. The investigators' data indicate that negative emotions and trauma reminders are associated with relapse for smokers with PTSD. In this context, an ideal strategy may be to combine evidence-based PTSD treatment with intensive smoking cessation treatment to maximize quit rates. Cognitive processing therapy (CPT) is a well-established evidence-based treatment for PTSD. The investigators have successfully developed a treatment manual that combines CPT with cognitive-behavioral counseling for smoking cessation. Contingency management (CM) is another intensive behavioral treatment that has been shown to help with reducing smoking. CM provides positive reinforcers such as money to individuals misusing substances contingent upon abstinence from use. The primary goal of this study is to evaluate the efficacy of a treatment that combines CM with cognitive-behavioral smoking cessation counseling, smoking cessation medication, and CPT. Proposed is a randomized, two-arm clinical trial in which 120 Veteran smokers with PTSD will be randomized to either: 1) COGNITIVE PROCESSING THERAPY with SMOKING ABSTINENCE REINFORCEMENT THERAPY (CPT-SMART) or 2) COMBINED CONTACT CONTROL, an intervention identical to CPT-SMART in PTSD and smoking treatment, except for using payment that is not contingent on abstinence. Specific aims include: AIM 1) To evaluate the efficacy of CPT-SMART on rates of short- and long-term abstinence from cigarettes; AIM 2) To evaluate the impact of CPT-SMART on treatment engagement and utilization; and an EXPLORATORY AIM) To explore mechanisms of CPT-SMART on long-term smoking abstinence. The positive public health impact of reducing smoking among Veterans with PTSD could be enormous as it would prevent significant smoking-related morbidity and mortality.

2019-11-07

2024-09-30

2024-09-30

Recruiting

Early phase I

120

Inclusion Criteria: * Is Veteran * Is between the ages of 18 and 80 * Smokes ten or more cigarettes per day for the past year * Has been smoking for at least the past year * Meets criteria for current PTSD * Speaks and writes English * Is willing to attempt smoking cessation and trauma-focused psychotherapy Exclusion Criteria: * Has had myocardial infarction in the past 6 months * Uses other forms of nicotine that he/she is unwilling to stop * Is pregnant * Has a primary psychotic disorder * Has a current substance use disorder other than tobacco use disorder * Has a contraindication to bupropion use with no medical clearance to use it * Is unwilling to use bupropion * Is receiving other behavioral smoking counseling or trauma-focused therapy or plans to do so during the study period * Is currently imprisoned or in psychiatric hospitalization

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, two-arm clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-04-19