Trial Outcomes & Findings for Nicotine Patch Pretreatment for Smoking Cessation in PTSD (NCT NCT00625131)

NCT ID: NCT00625131

Last Updated: 2014-11-20

Results Overview

Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 87 participants
• Primary outcome timeframe: Week prior to Session 12 at 6 weeks post-treatment
• Results posted on: 2014-11-20

Participant Flow

Participant milestones

Measure	Active Nicotine Patch Group Transdermal nicotine patch Nicotine: Delivered through transdermal nicotine patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Placebo Patch Group Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Not Randomized This arm includes patients who met screening criteria for entry into the randomization, but withdrew prior to randomization.
Overall Study STARTED	38	44	5
Overall Study COMPLETED	34	42	0
Overall Study NOT COMPLETED	4	2	5

Reasons for withdrawal

Measure	Active Nicotine Patch Group Transdermal nicotine patch Nicotine: Delivered through transdermal nicotine patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Placebo Patch Group Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Not Randomized This arm includes patients who met screening criteria for entry into the randomization, but withdrew prior to randomization.
Overall Study Lost to Follow-up	3	2	0
Overall Study Withdrawal by Subject	1	0	5

Baseline Characteristics

Nicotine Patch Pretreatment for Smoking Cessation in PTSD

Baseline characteristics by cohort

Measure	Arm 1 n=38 Participants Transdermal nicotine patch Nicotine: Delivered through transdermal nicotine patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Arm 2 n=44 Participants Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Total n=82 Participants Total of all reporting groups
Age, Continuous	45.16 years STANDARD_DEVIATION 9.61 • n=5 Participants	44.48 years STANDARD_DEVIATION 11.31 • n=7 Participants	44.79 years STANDARD_DEVIATION 10.51 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	30 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	44 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	44 participants n=7 Participants	82 participants n=5 Participants

PRIMARY outcome

Timeframe: Week prior to Session 12 at 6 weeks post-treatment

Population: Any participants who did not attend Session 12 for any reason (i.e., lost to contact, withdrawn after beginning treatment) were counted as smoking (i.e., intent-to-treat analyses, missing = smoking).

Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment

Outcome measures

Measure	Active Nicotine Patch Group n=38 Participants Transdermal nicotine patch Nicotine: Delivered through transdermal nicotine patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Placebo Patch Group n=44 Participants Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant
Smoking Abstinence, Self-reported	5 participants	11 participants

SECONDARY outcome

Timeframe: Session 12 (6 weeks post-treatment)

Population: Please note that this secondary outcome (bioverification by CO reading) is not a measure of complete smoking abstinence during the study period (or during the week prior to the session - see Primary Outcome). It is independent of self-reported smoking abstinence. It is not unexpected that CO readings different than self-reported smoking.

Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment)

Outcome measures

Measure	Active Nicotine Patch Group n=21 Participants Transdermal nicotine patch Nicotine: Delivered through transdermal nicotine patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Placebo Patch Group n=21 Participants Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant
Carbon Monoxide Monitoring	8 participants	5 participants

SECONDARY outcome

Timeframe: Daily between visits 2-12

Mean smoking craving score (as measured during daily ecological momentary, or diary, assessments) for participants by group during the two week period of placebo/active pre-treatment. This is the main period of interest, as it was hypothesized that use of active nicotine patch would reduce smoking cravings during the pre-quit period. The craving score is based on a single diary item "Please rate your desire to smoke right now" with a Likert scale score ranging from 1 (none) to 5 (severe). Higher craving is "worse," as lower craving is presumed to reflect decreased risk of smoking lapse or relapse.

Outcome measures

Measure	Active Nicotine Patch Group n=32 Participants Transdermal nicotine patch Nicotine: Delivered through transdermal nicotine patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Placebo Patch Group n=41 Participants Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant
Smoking Craving	2.48 units on a scale Standard Deviation 1.40	2.59 units on a scale Standard Deviation 1.24

Adverse Events

Active Nicotine Patch Group

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo Patch Group

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active Nicotine Patch Group n=38 participants at risk Transdermal nicotine patch Nicotine: Delivered through transdermal nicotine patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Placebo Patch Group n=44 participants at risk Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant
Respiratory, thoracic and mediastinal disorders Hospitalization for pre-existing Chronic Obstructive Pulmonary Disease (COPD)	0.00% 0/38 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.	2.3% 1/44 • Number of events 2 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.
Blood and lymphatic system disorders Hospitalization for preexisting circulatory disorder	0.00% 0/38 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.	2.3% 1/44 • Number of events 1 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.

Other adverse events

Measure	Active Nicotine Patch Group n=38 participants at risk Transdermal nicotine patch Nicotine: Delivered through transdermal nicotine patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant	Placebo Patch Group n=44 participants at risk Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant
Gastrointestinal disorders nausea	0.00% 0/38 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.	9.1% 4/44 • Number of events 6 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.
General disorders Surgical Intervention, non-study related	7.9% 3/38 • Number of events 3 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.	4.5% 2/44 • Number of events 2 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.
Psychiatric disorders Exacerbation of pre-existing PTSD symptoms	10.5% 4/38 • Number of events 4 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.	15.9% 7/44 • Number of events 7 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.
Psychiatric disorders Sleep disturbance and/or increased nightmares	18.4% 7/38 • Number of events 7 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.	4.5% 2/44 • Number of events 2 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.
Skin and subcutaneous tissue disorders Itching and/or skin rash at site of patch placement	15.8% 6/38 • Number of events 6 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.	6.8% 3/44 • Number of events 3 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.
Musculoskeletal and connective tissue disorders Orthopedic accident, not study related	0.00% 0/38 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.	4.5% 2/44 • Number of events 2 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.
Gastrointestinal disorders Dry mouth	7.9% 3/38 • Number of events 3 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.	0.00% 0/44 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.
Gastrointestinal disorders Gas and/or hemorrhoid pain	5.3% 2/38 • Number of events 4 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.	0.00% 0/44 • AE data were collected in real time during each participant session or contact from baseline to 6 month follow-up (ranging from one day to nine months). These data represent AEs reported by all participants over the entire 4 years of data collection. Serious AEs were reviewed with the PI immediately after they were reported to the study coordinator. Non-serious AEs were reviewed with the PI at weekly staff meetings.

Additional Information

Angela Kirby, MS; Regulatory Coordinator

VA Medical Center, Durham, NC

Phone: 9192860411

Email: angela.kirby@va.gov

Results disclosure agreements

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