Smoking Cessation
Conditions
Keywords
PTSD, smoking cessation, nicotine patch
Brief summary
The investigators propose to evaluate the relationship between PTSD, mood, craving and withdrawal symptoms and factors associated with relapse in the context of a randomized clinical smoking cessation trial. The use of supplemental nicotine administration (SNA) during a pre-treatment phase before a targeted quit date is an innovative development in smoking cessation, and may be helpful in treating smokers with PTSD. The use of SNA during ad lib smoking for smokers with PTSD is predicted to reduce both the physiological and emotional dependence on inhaled nicotine, thereby increasing the odds of successful smoking cessation. Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions (active patch versus placebo patch) for 2 weeks before a target quit-smoking date. All participants will receive brief cognitive-behavioral therapy (CBT) and will begin standard nicotine replacement therapy on their quit day. PTSD symptoms, mood, smoking craving and withdrawal symptoms will be evaluated using electronic diary assessment for one week prior to the pre-cessation period, during the 2-week pre-cessation period, and 6 weeks post quit date. The study is designed to address the following aims: Specific Aim 1: To examine the effects of SNA on PTSD symptoms, mood, craving and withdrawal through electronic diary assessment. Hypothesis 1.1. SNA will decrease craving for cigarettes during the 2 week pretreatment period as compared to the placebo patch condition. Hypothesis 1.2. SNA will decrease the perceived improvement in mood and PTSD symptoms associated with smoking behavior. Hypothesis 1.3. SNA during the pre-cessation period will result in a reduction of withdrawal symptoms following the quit-date. Specific Aim 2: To evaluate the effect of SNA on quit rates among smokers with PTSD. Hypothesis 2. SNA during the pre-cessation period will result in improved quit rates Specific Aim 3: To investigate potential predictors of relapse including PTSD symptom severity, mood, anxiety sensitivity, distress tolerance, and self-efficacy. Hypothesis 3.1 - 3.5 Increased PTSD symptom severity, increased baseline negative affect, increased anxiety sensitivity, decreased distress tolerance, and lower self-efficacy each will independently be associated with shorter abstinence from smoking.
Interventions
DRUGnicotine patch
Nicotine patch, 7-21 mg.
DRUGplacebo patch
placebo patch used from weeks 4-6
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* between ages of 18 and 70 * smoker who has smoked 10 or more cigarettes per day during past year * current PTSD * English speaker * study physician clearance
Exclusion criteria
* organic mental disorder, schizophrenia, current manic syndrome, lifetime but not current PTSD, or current substance abuse/dependence * pregnancy * unstable medications * myocardial infarction in past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Self-reporting Abstinence During 6 Weeks Post Quit | 6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence as Measured by Exhaled Carbon Monoxide (CO) | Session 12, 6 weeks post-quit | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diary Ratings of Cravings | During pre-quit period; two weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Patch Nicotine patch given pre-quit attempt at weeks 4 through 6
nicotine patch: Nicotine patch, 7-21 mg. | 33 |
| Placebo Patch placebo patch given pre-quit from weeks 4 through 6
placebo patch: placebo patch used from weeks 4-6 | 32 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by PI | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 9 |
Baseline characteristics
| Characteristic | Nicotine Patch | Placebo Patch | Total |
|---|---|---|---|
| Age, Continuous | 41.15 years STANDARD_DEVIATION 10.57 | 42.69 years STANDARD_DEVIATION 7.81 | 41.91 years STANDARD_DEVIATION 9.27 |
| Region of Enrollment United States | 33 participants | 32 participants | 65 participants |
| Sex: Female, Male Female | 19 Participants | 17 Participants | 36 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 30 | 15 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 |
Outcome results
Primary
Participants Self-reporting Abstinence During 6 Weeks Post Quit
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Patch | Participants Self-reporting Abstinence During 6 Weeks Post Quit | 16 participants |
| Placebo Patch | Participants Self-reporting Abstinence During 6 Weeks Post Quit | 13 participants |
Secondary
Abstinence as Measured by Exhaled Carbon Monoxide (CO)
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.
Time frame: Session 12, 6 weeks post-quit
Population: Data was available on 30 participants who attended Session 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Patch | Abstinence as Measured by Exhaled Carbon Monoxide (CO) | 8 participants |
| Placebo Patch | Abstinence as Measured by Exhaled Carbon Monoxide (CO) | 7 participants |
Other Pre-specified
Diary Ratings of Cravings
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.
Time frame: During pre-quit period; two weeks
Population: 61 participants provided this EMA data during the pre-quit period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patch | Diary Ratings of Cravings | Ad Lib period | 2.88 units on a scale | Standard Error 0.14 |
| Nicotine Patch | Diary Ratings of Cravings | Patch pre-treatment period | 2.57 units on a scale | Standard Error 0.14 |
| Placebo Patch | Diary Ratings of Cravings | Ad Lib period | 3.11 units on a scale | Standard Error 0.14 |
| Placebo Patch | Diary Ratings of Cravings | Patch pre-treatment period | 2.84 units on a scale | Standard Error 0.14 |