Clinical trial NCT03978442: CPT-SMART for Treatment of PTSD and Cigarette Smoking
Official title: CPT-SMART for Treatment of PTSD and Cigarette Smoking
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Smoking
Stress Disorders, Post-Traumatic
Keywords: Stress Disorders, Post-Traumatic
Smoking
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-06-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, two-arm clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 PTSD smokers. The investigators' data indicate that negative affect and trauma reminders are a significant antecedent of relapse for PTSD smokers. Further, despite evidence that nicotine may exacerbate PTSD symptoms, many smokers with PTSD expect that smoking helps manage their symptoms. In this context, an ideal strategy may be to combine evidence-based PTSD treatment with intensive smoking cessation treatment to maximize quit rates in this at-risk population.

Cognitive processing therapy (CPT) is a well-established evidence-based treatment for PTSD. The investigators have successfully developed a treatment manual that integrates CPT with guideline-concordant cognitive-behavioral counseling for smoking cessation. Contingency management (CM) is an intensive behavioral treatment that has demonstrated efficacy for reducing smoking in a range of difficult-to-treat populations, including individuals with psychiatric disorders. CM provides positive reinforcers (e.g., vouchers, money) to individuals misusing substances contingent upon bioverified abstinence from drug use. The primary goal of the current study is to evaluate the efficacy of an intervention that combines clinic-based CM using twice weekly monitoring with salivary cotinine test strips, cognitive-behavioral smoking cessation counseling, smoking cessation medication, and evidence-based PTSD treatment. 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) - an intervention that combines evidenced-based PTSD treatment with guideline-concordant cognitive-behavioral smoking cessation counseling, bupropion, and intensive behavioral therapy through CM; or 2) COMBINED CONTACT CONTROL: an intervention identical to CPT-SMART in PTSD and smoking treatment, except for using non-contingent payment (i.e., yoked CM) to control for compensation and monitoring.

Specific aims include: AIM 1) To evaluate the efficacy of CPT-SMART on rates of short- and long-term abstinence from cigarettes (assessed with multiple measures including bioverified abstinence) measured at 1-week post-treatment, 4-months, and 6 months; 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, including self-efficacy, salience of smoking, and psychiatric symptom reduction. The VA has already implemented CM for treatment of substance abuse. If shown efficacious, a combined PTSD treatment plus incentive-based approaches for smoking could be implemented into specialty PTSD programs. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants whose self-report of 7 day point prevalence abstinence from smoking is bioverified
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Number of participants whose self-report of 30 day point prevalence abstinence from smoking is bioverified
timeFrame: 6 month follow-up
measure: Number of participants whose self-report of 7 day point prevalence abstinence from smoking is bioverified
timeFrame: 4 month follow-up
measure: Number of participants whose self-report of 30 day point prevalence abstinence from smoking is bioverified
timeFrame: 4 month follow-up
measure: Number of participants who self-report prolonged abstinence
timeFrame: 4 month follow-up
measure: Number of participants who self-report prolonged abstinence
timeFrame: 6 month follow-up
measure: Number of participants who self-report early abstinence
timeFrame: Measured at the post-treatment visit (2 weeks after treatment completed)
measure: Number of participants who attended eight or more sessions of combined CPT and CBT for smoking
timeFrame: Measured at the post-treatment visit (2 weeks after treatment completed)
measure: Number of sessions attended by participants
timeFrame: Measured at the post-treatment visit (2 weeks after treatment completed)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Eric A Dedert, PhD
role: PRINCIPAL_INVESTIGATOR
References: