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CPT-SMART for Treatment of PTSD and Cigarette Smoking (CPT-SMART)

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ClinicalTrials.gov Identifier: NCT03978442
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE November 7, 2019
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
Number of participants whose self-report of 7 day point prevalence abstinence from smoking is bioverified [ Time Frame: 6 month follow-up ]
7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03978442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Number of participants whose self-report of 30 day point prevalence abstinence from smoking is bioverified [ Time Frame: 6 month follow-up ]
    30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
  • Number of participants whose self-report of 7 day point prevalence abstinence from smoking is bioverified [ Time Frame: 3 month follow-up ]
    7-day point prevalence abstinence is defined as no smoking in the prior 7 days.
  • Number of participants whose self-report of 30 day point prevalence abstinence from smoking is bioverified [ Time Frame: 3 month follow-up ]
    30-day point prevalence abstinence is defined as no smoking in the prior 30 days.
  • Number of participants who self-report prolonged abstinence [ Time Frame: 3 month follow-up ]
    Prolonged abstinence is defined as 30 days abstinent.
  • Number of participants who self-report prolonged abstinence [ Time Frame: 6 month follow-up ]
    Prolonged abstinence is defined as 30 days abstinent.
  • Number of participants who self-report early abstinence [ Time Frame: Measured at the post-treatment visit (2 weeks after treatment completed) ]
    Early abstinence is defined as 2 consecutive sessions abstinent in first month of quit attempt.
  • Number of participants who attended eight or more sessions of combined CPT and CBT for smoking [ Time Frame: Measured at the post-treatment visit (2 weeks after treatment completed) ]
    Those who complete eight or more treatment sessions will be considered to have had an adequate treatment dose.
  • Number of sessions attended by participants [ Time Frame: Measured at the post-treatment visit (2 weeks after treatment completed) ]
    The average number of treatment sessions attended by participants in each group will be considered a measure of treatment engagement.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CPT-SMART for Treatment of PTSD and Cigarette Smoking
Official Title  ICMJE CPT-SMART for Treatment of PTSD and Cigarette Smoking
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, 3-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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, two-arm clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking
  • Stress Disorders, Post-Traumatic
Intervention  ICMJE
  • Behavioral: Smoking Cessation Cognitive Behavioral Therapy (CBT)
    12 sessions of cognitive behavioral therapy for smoking cessation, designed to help participants prepare for quitting smoking, make a quit attempt, and stay quit from smoking.
    Other Name: CBT
  • Drug: Bupropion
    All medically eligible participants will be prescribed bupropion to begin 7 days before the quit date and continued through 12 weeks post-quit. Participants will be scheduled to begin at 150mg/day of bupropion for at least 3 days before titrating up to 300mg/day dose of bupropion.
    Other Name: Zyban
  • Behavioral: Cognitive Processing Therapy
    12 sessions of CPT, which is a well-established trauma-focused psychotherapy for PTSD that has demonstrated efficacy and effectiveness in Veterans.
    Other Name: CPT
  • Behavioral: Smoking Abstinence Reinforcement Therapy
    Monetary reinforcement for smoking abstinence that is bioverified by breath carbon monoxide and saliva samples.
    Other Name: SMART
  • Behavioral: Yoked Contingency Management
    Participants in the yoked control will receive the monetary reinforcement of their yoked participant regardless of smoking abstinence or session attendance.
    Other Name: Control CM
Study Arms  ICMJE
  • Experimental: CPT-SMART
    COGNITIVE PROCESSING THERAPY with SMOKING ABSTINENCE REINFORCEMENT THERAPY (CPT-SMART) - an intervention that combines evidence-based PTSD treatment with guideline-concordant cognitive-behavioral smoking cessation counseling, bupropion, and intensive behavioral therapy through CM.
    Interventions:
    • Behavioral: Smoking Cessation Cognitive Behavioral Therapy (CBT)
    • Drug: Bupropion
    • Behavioral: Cognitive Processing Therapy
    • Behavioral: Smoking Abstinence Reinforcement Therapy
  • Active Comparator: Combined Contact Yoked Control
    COMBINED CONTACT YOKED CONTROL (CCYC) - an intervention that is identical to CPT-SMART for PTSD and smoking treatment, except for using non-contingent payment (i.e., yoked CM) to control for compensation and monitoring.
    Interventions:
    • Behavioral: Smoking Cessation Cognitive Behavioral Therapy (CBT)
    • Drug: Bupropion
    • Behavioral: Cognitive Processing Therapy
    • Behavioral: Yoked Contingency Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2024
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric A Dedert, PhD (919) 286-0411 ext 175526 Eric.Dedert@va.gov
Contact: Angela C Kirby, MS (919) 286-0411 ext 7456 angela.kirby@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978442
Other Study ID Numbers  ICMJE MHBB-008-18F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric A Dedert, PhD Durham VA Medical Center, Durham, NC
PRS Account VA Office of Research and Development
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP