Trial Outcomes & Findings for Treatment of Smoking Among Individuals With PTSD (NCT NCT00937235)

NCT ID: NCT00937235

Last Updated: 2017-11-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 142 participants
• Primary outcome timeframe: At 3-month follow-up (6-month post-quit day)
• Results posted on: 2017-11-14

Participant Flow

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.

Participant milestones

Measure	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	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
Overall Study STARTED	72	70
Overall Study COMPLETED	72	70
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Smoking Among Individuals With PTSD

Baseline characteristics by cohort

Measure	Integrated Treatment n=72 Participants 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	Varenicline n=70 Participants 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	Total n=142 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	72 Participants n=93 Participants	70 Participants n=4 Participants	142 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	42.8 years STANDARD_DEVIATION 9.7 • n=93 Participants	42.6 years STANDARD_DEVIATION 10.2 • n=4 Participants	42.7 years STANDARD_DEVIATION 9.9 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	30 Participants n=4 Participants	56 Participants n=27 Participants
Sex: Female, Male Male	46 Participants n=93 Participants	40 Participants n=4 Participants	86 Participants n=27 Participants
Region of Enrollment United States	72 participants n=93 Participants	70 participants n=4 Participants	142 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Integrated Treatment n=72 Participants 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	Varenicline n=70 Participants 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
Number of Participants With 7-day Point Prevalence Smoking Abstinence	8 Participants	11 Participants

SECONDARY outcome

Timeframe: At end of 3-month follow-up

Level of cotinine in blood

Outcome measures

Measure	Integrated Treatment n=72 Participants 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	Varenicline n=70 Participants 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
Blood Serum Cotinine	156.0 ng/mL Standard Deviation 119.4	149.2 ng/mL Standard Deviation 149.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Integrated Treatment n=72 Participants 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	Varenicline n=70 Participants 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
Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment	11.19 Scores on a scale Standard Deviation 10.63	18.84 Scores on a scale Standard Deviation 11.59

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Integrated Treatment n=72 Participants 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	Varenicline n=70 Participants 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
Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up	10.35 scores on a scale Standard Deviation 11.73	16.74 scores on a scale Standard Deviation 12.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Integrated Treatment n=72 Participants 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	Varenicline n=70 Participants 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
Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment	6.34 Scores on a scale Standard Deviation 6.00	11.84 Scores on a scale Standard Deviation 7.43

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Integrated Treatment n=72 Participants 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	Varenicline n=70 Participants 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
Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up	6.95 Scores on a scale Standard Deviation 7.39	11.45 Scores on a scale Standard Deviation 7.73

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Integrated Treatment n=72 Participants 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	Varenicline n=70 Participants 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
TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)	14.31 Number of Cigarettes Smoked Standard Deviation 29.00	17.03 Number of Cigarettes Smoked Standard Deviation 28.15

SECONDARY outcome

Timeframe: 3-month follow-up

Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit

Outcome measures

Measure	Integrated Treatment n=72 Participants 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	Varenicline n=70 Participants 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
TLFB - Cigarettes Smoked Week Before 3-Month Follow-up	32.92 Number of Cigarettes Smoked Standard Deviation 45.64	25.85 Number of Cigarettes Smoked Standard Deviation 44.79

Adverse Events

Integrated Treatment

Serious events: 6 serious events

Other events: 64 other events

Deaths: 0 deaths

Varenicline

Serious events: 4 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Measure	Integrated Treatment n=72 participants at risk 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	Varenicline n=70 participants at risk 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
Psychiatric disorders Suicidal Ideation	4.2% 3/72 • Number of events 3 • 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).	0.00% 0/70 • 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).
Surgical and medical procedures Hospitalization secondary to drug or alcohol relapse	1.4% 1/72 • Number of events 1 • 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).	1.4% 1/70 • Number of events 1 • 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).
Respiratory, thoracic and mediastinal disorders Respiratory issue	2.8% 2/72 • Number of events 3 • 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).	1.4% 1/70 • Number of events 1 • 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).
Psychiatric disorders Cocaine relapse with no hospitalization	0.00% 0/72 • 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).	1.4% 1/70 • Number of events 1 • 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).
Injury, poisoning and procedural complications Broken ankle + hospitalization	1.4% 1/72 • Number of events 1 • 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).	0.00% 0/70 • 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).
General disorders Hospitalization (unrelated)	0.00% 0/72 • 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).	1.4% 1/70 • Number of events 1 • 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).

Other adverse events

Measure	Integrated Treatment n=72 participants at risk 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	Varenicline n=70 participants at risk 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
General disorders Miscellaneous	88.9% 64/72 • 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).	82.9% 58/70 • 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).

Additional Information

Dr. Edna Foa

University of Pennsylvania

Phone: 2157463327

Email: foa@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place