Trial Outcomes & Findings for Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD) (NCT NCT01055886)

Results Overview

In the 6 week post-quit period, participants completed ecological momentary assessment (EMA), or diary, ratings of their smoking behavior. This outcome reflects the number of participants who reported not relapsing (i.e., smoking 7 days in a row) during the 6 weeks post-quit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12

Results posted on

2015-01-06

Participant Flow

110 participants signed consent. 41 were excluded: 25 didn't have current PTSD, 7 had contraindicated other psychiatric disorder, 6 didn't meet smoking criteria, 1 was not willing to quit smoking, 1 didn't want to participate after signing consent, and 1 left before completing screen. Another 4 were lost to contact or w/d before randomization.

Participant milestones

Participant milestones
Measure	Nicotine Patch Nicotine patch given pre-quit attempt at weeks 4 through 6 nicotine patch: Nicotine patch, 7-21 mg.	Placebo Patch placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6
Overall Study STARTED	33	32
Overall Study Reached Pre-quit Period	30	31
Overall Study COMPLETED	28	21
Overall Study NOT COMPLETED	5	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Nicotine Patch Nicotine patch given pre-quit attempt at weeks 4 through 6 nicotine patch: Nicotine patch, 7-21 mg.	Placebo Patch placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6
Overall Study Withdrawal by Subject	4	9
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by PI	0	1

Baseline Characteristics

Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nicotine Patch n=33 Participants Nicotine patch given pre-quit attempt at weeks 4 through 6 nicotine patch: Nicotine patch, 7-21 mg.	Placebo Patch n=32 Participants placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6	Total n=65 Participants Total of all reporting groups
Age, Continuous	41.15 years STANDARD_DEVIATION 10.57 • n=5 Participants	42.69 years STANDARD_DEVIATION 7.81 • n=7 Participants	41.91 years STANDARD_DEVIATION 9.27 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	32 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12

Population: 37 participants completed the ecological momentary assessment (EMA; diary) ratings during the post-quit period.

In the 6 week post-quit period, participants completed ecological momentary assessment (EMA), or diary, ratings of their smoking behavior. This outcome reflects the number of participants who reported not relapsing (i.e., smoking 7 days in a row) during the 6 weeks post-quit.

Outcome measures

Outcome measures
Measure	Nicotine Patch n=20 Participants Nicotine patch given pre-quit attempt at weeks 4 through 6 nicotine patch: Nicotine patch, 7-21 mg.	Placebo Patch n=17 Participants placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6
Participants Self-reporting Abstinence During 6 Weeks Post Quit	16 participants	13 participants

SECONDARY outcome

Timeframe: Session 12, 6 weeks post-quit

Population: Data was available on 30 participants who attended Session 12.

This outcome reflects the number of participants whose exhaled carbon monoxide (CO; a measure of smoking) indicated abstinence (i.e., 6 parts per million or less) at Session 12, which occurred six weeks post-quit.

Outcome measures

Outcome measures
Measure	Nicotine Patch n=15 Participants Nicotine patch given pre-quit attempt at weeks 4 through 6 nicotine patch: Nicotine patch, 7-21 mg.	Placebo Patch n=15 Participants placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6
Abstinence as Measured by Exhaled Carbon Monoxide (CO)	8 participants	7 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During pre-quit period; two weeks

Population: 61 participants provided this EMA data during the pre-quit period.

Participants provided (through ecological momentary assessment) ratings of their smoking craving. This outcome reflects differences between ad lib (or typical) smoking craving compared to smoking craving reported during the pre-quit period. Craving was reported from a single item "Please indicate your desire/craving to smoke," and answers were provided in a 5-point Likert scale where 1=no craving and 5=severe craving. Higher scores are presumed to be "worse" because they indicate increased craving, which is likely to lead to non-abstinence.

Outcome measures

Outcome measures
Measure	Nicotine Patch n=30 Participants Nicotine patch given pre-quit attempt at weeks 4 through 6 nicotine patch: Nicotine patch, 7-21 mg.	Placebo Patch n=31 Participants placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6
Diary Ratings of Cravings Ad Lib period	2.88 units on a scale Standard Error 0.14	3.11 units on a scale Standard Error 0.14
Diary Ratings of Cravings Patch pre-treatment period	2.57 units on a scale Standard Error 0.14	2.84 units on a scale Standard Error 0.14

Adverse Events

Nicotine Patch

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo Patch

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nicotine Patch n=30 participants at risk Nicotine patch given pre-quit attempt at weeks 4 through 6 nicotine patch: Nicotine patch, 7-21 mg.	Placebo Patch n=31 participants at risk placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6
Gastrointestinal disorders Nausea	16.7% 5/30 • Number of events 5	16.1% 5/31 • Number of events 5
Skin and subcutaneous tissue disorders Skin irritation at patch placement site	10.0% 3/30 • Number of events 3	16.1% 5/31 • Number of events 5
Psychiatric disorders Vivid dreams or nightmares	20.0% 6/30 • Number of events 6	9.7% 3/31 • Number of events 3
Psychiatric disorders Increased PTSD symptoms	10.0% 3/30 • Number of events 3	3.2% 1/31 • Number of events 1
Nervous system disorders Headache	6.7% 2/30 • Number of events 2	3.2% 1/31 • Number of events 1
Cardiac disorders Elevated blood pressure	0.00% 0/30	3.2% 1/31 • Number of events 1
Cardiac disorders Increased heart rate (self-reported)	3.3% 1/30 • Number of events 1	0.00% 0/31

Additional Information

Angela Kirby

VA Medical Center

Phone: 919-286-0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place