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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 : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease Intervention/treatment Phase
Smoking Stress Disorders, Post-Traumatic Behavioral: Smoking Cessation Cognitive Behavioral Therapy (CBT) Drug: Bupropion Behavioral: Cognitive Processing Therapy Behavioral: Smoking Abstinence Reinforcement Therapy Behavioral: Yoked Contingency Management Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, two-arm clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CPT-SMART for Treatment of PTSD and Cigarette Smoking
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Bupropion

Arm Intervention/treatment
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.
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

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.
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: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Number of participants who self-report prolonged abstinence [ Time Frame: 3 month follow-up ]
    Prolonged abstinence is defined as 30 days abstinent.

  5. Number of participants who self-report prolonged abstinence [ Time Frame: 6 month follow-up ]
    Prolonged abstinence is defined as 30 days abstinent.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978442


Contacts
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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

Locations
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United States, North Carolina
Durham VA Medical Center, Durham, NC Not yet recruiting
Durham, North Carolina, United States, 27705
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   
Principal Investigator: Eric A Dedert, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Eric A Dedert, PhD Durham VA Medical Center, Durham, NC

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03978442     History of Changes
Other Study ID Numbers: MHBB-008-18F
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Stress Disorders, Post-Traumatic
Smoking
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors