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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA023507 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated Treatment | Experimental | Prolonged Exposure + Varenicline + Medication Management Counseling |
|
| Varenicline | Active Comparator | Varenicline + Medication Management Counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | 1 mg tablets, orally, twice daily x 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 7-day Point Prevalence Smoking Abstinence | Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of <15ng/ml, and CO < 10 ppm. | At 3-month follow-up (6-month post-quit day) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Serum Cotinine | Level of cotinine in blood | At end of 3-month follow-up |
| Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment | Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51. Higher scores indicate higher/worse levels of PTSD. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edna B Foa, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety | Philadelphia | Pennsylvania | 19104 | United States |
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| Label | URL |
|---|---|
| Center for the Treatment and Study of Anxiety | View source |
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Participants were recruited through advertisements and referrals to the University of Pennsylvania's Center for the Treatment and Study of Anxiety (CTSA), Transdisciplinary Tobacco Use Research Center (TTURC), and the Philadelphia VA Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Integrated Treatment | Prolonged Exposure + Varenicline + Medication Management Counseling Varenicline: 1 mg tablets, orally, twice daily x 12 weeks Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders |
| FG001 | Varenicline | Varenicline + Medication Management Counseling Varenicline: 1 mg tablets, orally, twice daily x 12 weeks Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Integrated Treatment | Prolonged Exposure + Varenicline + Medication Management Counseling Varenicline: 1 mg tablets, orally, twice daily x 12 weeks Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With 7-day Point Prevalence Smoking Abstinence | Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of <15ng/ml, and CO < 10 ppm. | Posted | Count of Participants | Participants | At 3-month follow-up (6-month post-quit day) |
|
Adverse event data was collected over the entire duration of data collection (2009-2015).
Participants were assessed at each visit for adverse events (which typically occurred weekly).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Integrated Treatment | Prolonged Exposure + Varenicline + Medication Management Counseling Varenicline: 1 mg tablets, orally, twice daily x 12 weeks Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation Prolonged Exposure: 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscellaneous | General disorders | Systematic Assessment | Increased fatigue, increased/decreased appetite, dry mouth, diarrhea, etc |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edna Foa | University of Pennsylvania | 2157463327 | foa@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D014029 | Tobacco Use Disorder |
| D013313 | Stress Disorders, Post-Traumatic |
| D016540 | Smoking Cessation |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019966 |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Medication Management Counseling | Behavioral | 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation |
|
| Prolonged Exposure | Behavioral | 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders |
|
|
| Post-treatment, occurring 12 weeks after the start of treatment (week 0) |
| Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up | Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51. Higher scores indicate higher/worse levels of PTSD. | 3-month follow-up |
| Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment | Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50. Higher scores indicate higher/worse levels of depression. | Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0) |
| Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up | Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50. Higher scores indicate higher/worse levels of depression. | 3-month follow-up |
| TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment) | Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit | Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit |
| TLFB - Cigarettes Smoked Week Before 3-Month Follow-up | Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit | 3-month follow-up |
| BG001 | Varenicline | Varenicline + Medication Management Counseling Varenicline: 1 mg tablets, orally, twice daily x 12 weeks Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Varenicline |
Varenicline + Medication Management Counseling Varenicline: 1 mg tablets, orally, twice daily x 12 weeks Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation |
|
|
| Secondary | Blood Serum Cotinine | Level of cotinine in blood | Posted | Mean | Standard Deviation | ng/mL | At end of 3-month follow-up |
|
|
|
| Secondary | Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment | Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51. Higher scores indicate higher/worse levels of PTSD. | Posted | Mean | Standard Deviation | Scores on a scale | Post-treatment, occurring 12 weeks after the start of treatment (week 0) |
|
|
|
| Secondary | Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up | Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51. Higher scores indicate higher/worse levels of PTSD. | Posted | Mean | Standard Deviation | scores on a scale | 3-month follow-up |
|
|
|
| Secondary | Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment | Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50. Higher scores indicate higher/worse levels of depression. | Posted | Mean | Standard Deviation | Scores on a scale | Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0) |
|
|
|
| Secondary | Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up | Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50. Higher scores indicate higher/worse levels of depression. | Posted | Mean | Standard Deviation | Scores on a scale | 3-month follow-up |
|
|
|
| Secondary | TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment) | Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit | Posted | Mean | Standard Deviation | Number of Cigarettes Smoked | Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit |
|
|
|
| Secondary | TLFB - Cigarettes Smoked Week Before 3-Month Follow-up | Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit | Posted | Mean | Standard Deviation | Number of Cigarettes Smoked | 3-month follow-up |
|
|
|
| 0 |
| 72 |
| 6 |
| 72 |
| 64 |
| 72 |
| EG001 | Varenicline | Varenicline + Medication Management Counseling Varenicline: 1 mg tablets, orally, twice daily x 12 weeks Medication Management Counseling: 15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation | 0 | 70 | 4 | 70 | 58 | 70 |
| Hospitalization secondary to drug or alcohol relapse | Surgical and medical procedures | Non-systematic Assessment |
|
| Respiratory issue | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hospitalizations secondary to respiratory conditions (pneumonia, COPD, flu) for reasons unrelated to study procedures |
|
| Cocaine relapse with no hospitalization | Psychiatric disorders | Systematic Assessment | Cocaine relapse with no hospitalization |
|
| Broken ankle + hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | Broken ankle unrelated to study procedures that required hospitalization |
|
| Hospitalization (unrelated) | General disorders | Systematic Assessment | Reason for hospitalization unknown, but noted as unrelated to study procedures (general medical issue) |
|
|
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| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D015438 | Health Behavior |
| D011810 | Quinoxalines |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |