Cigarette Smoking, Nicotine Dependence, Post-traumatic Stress Disorder, Tobacco Use Disorder
Conditions
Keywords
Smoking Cessation, Anxiety, Behavior Therapy, Varenicline
Brief summary
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.
Interventions
DRUGVarenicline
1 mg tablets, orally, twice daily x 12 weeks
BEHAVIORALMedication Management Counseling
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
BEHAVIORALProlonged Exposure
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female treatment-seeking cigarette smokers between 18-75 years old who smoke an average of ≥10 cigarettes/day during past year; * Current diagnosis of chronic PTSD (symptom duration \> 3 months) with clinically significant trauma-related symptoms (PSS-I \>= 20) * Live a commutable distance to the University of Pennsylvania and agree to follow-up visits; * Agree not to use other forms of smoking cessation treatment or treatment for PTSD during the study period; * If taking SRIs or other medications at intake, have been on stable medication and dose regimen for past 3 months and agree to maintain current regimen if possible; * Demonstrate the capacity to provide informed consent; * Speak and read English.
Exclusion criteria
* History of drug or alcohol abuse or dependence in past 3 months or any unwillingness to not smoke marijuana during the first 13 weeks of the study; * Current and continuing intimate relationship with a physically or sexually abusive partner; * Current suicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment; * Prior serious suicide attempt, as judged by the evaluator to have a high degree of lethality; * Current or past history of psychosis (bipolar disorder or schizophrenia); * History of significant cardiovascular disease or uncontrolled hypertension in past 6 months; * Women who are pregnant, likely to become pregnant (i.e., sexually active and not using contraception), or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 7-day Point Prevalence Smoking Abstinence | At 3-month follow-up (6-month post-quit day) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment | Post-treatment, occurring 12 weeks after the start of treatment (week 0) | 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. |
| Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up | 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. |
| Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment | Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0) | 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. |
| Blood Serum Cotinine | At end of 3-month follow-up | Level of cotinine in blood |
| TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment) | Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit | Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit |
| TLFB - Cigarettes Smoked Week Before 3-Month Follow-up | 3-month follow-up | Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit |
| Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 72 |
| 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 | 70 |
| Total | 142 |
Baseline characteristics
| Characteristic | Varenicline | Integrated Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 72 Participants | 142 Participants |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 10.2 | 42.8 years STANDARD_DEVIATION 9.7 | 42.7 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment United States | 70 participants | 72 participants | 142 participants |
| Sex: Female, Male Female | 30 Participants | 26 Participants | 56 Participants |
| Sex: Female, Male Male | 40 Participants | 46 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 70 |
| other Total, other adverse events | 64 / 72 | 58 / 70 |
| serious Total, serious adverse events | 6 / 72 | 4 / 70 |
Outcome results
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.
Time frame: At 3-month follow-up (6-month post-quit day)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Integrated Treatment | Number of Participants With 7-day Point Prevalence Smoking Abstinence | 8 Participants |
| Varenicline | Number of Participants With 7-day Point Prevalence Smoking Abstinence | 11 Participants |
Secondary
Blood Serum Cotinine
Level of cotinine in blood
Time frame: At end of 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Treatment | Blood Serum Cotinine | 156.0 ng/mL | Standard Deviation 119.4 |
| Varenicline | Blood Serum Cotinine | 149.2 ng/mL | Standard Deviation 149.6 |
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.
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Treatment | Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up | 6.95 Scores on a scale | Standard Deviation 7.39 |
| Varenicline | Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up | 11.45 Scores on a scale | Standard Deviation 7.73 |
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.
Time frame: Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Treatment | Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment | 6.34 Scores on a scale | Standard Deviation 6 |
| Varenicline | Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment | 11.84 Scores on a scale | Standard Deviation 7.43 |
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.
Time frame: Post-treatment, occurring 12 weeks after the start of treatment (week 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Treatment | Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment | 11.19 Scores on a scale | Standard Deviation 10.63 |
| Varenicline | Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment | 18.84 Scores on a scale | Standard Deviation 11.59 |
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.
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Treatment | Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up | 10.35 scores on a scale | Standard Deviation 11.73 |
| Varenicline | Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up | 16.74 scores on a scale | Standard Deviation 12.11 |
Secondary
TLFB - Cigarettes Smoked Week Before 3-Month Follow-up
Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Treatment | TLFB - Cigarettes Smoked Week Before 3-Month Follow-up | 32.92 Number of Cigarettes Smoked | Standard Deviation 45.64 |
| Varenicline | TLFB - Cigarettes Smoked Week Before 3-Month Follow-up | 25.85 Number of Cigarettes Smoked | Standard Deviation 44.79 |
Secondary
TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)
Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit
Time frame: Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Treatment | TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment) | 14.31 Number of Cigarettes Smoked | Standard Deviation 29 |
| Varenicline | TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment) | 17.03 Number of Cigarettes Smoked | Standard Deviation 28.15 |