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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Patch | Active Comparator | Nicotine patch given pre-quit attempt at weeks 4 through 6 |
|
| placebo patch | Placebo Comparator | placebo patch given pre-quit from weeks 4 through 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotine patch | Drug | Nicotine patch, 7-21 mg. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Session 12, 6 weeks post-quit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick S. Calhoun, Ph.D. | VA Medical Center; Duke University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center | Durham | North Carolina | 27705 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Patch | Nicotine patch given pre-quit attempt at weeks 4 through 6 nicotine patch: Nicotine patch, 7-21 mg. |
| FG001 | Placebo Patch | placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
65 participants were randomized and began study procedures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Patch | Nicotine patch given pre-quit attempt at weeks 4 through 6 nicotine patch: Nicotine patch, 7-21 mg. |
| BG001 | Placebo Patch | placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 37 participants completed the ecological momentary assessment (EMA; diary) ratings during the post-quit period. | Posted | Number | participants | 6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotine Patch | Nicotine patch given pre-quit attempt at weeks 4 through 6 nicotine patch: Nicotine patch, 7-21 mg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kirby | VA Medical Center | 919-286-0411 | 5526 | angela.kirby@va.gov |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| placebo patch | Drug | placebo patch used from weeks 4-6 |
|
| During pre-quit period; two weeks |
| Withdrawal by PI |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6 |
|
|
| 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. | Data was available on 30 participants who attended Session 12. | Posted | Number | participants | Session 12, 6 weeks post-quit |
|
|
|
| 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. | 61 participants provided this EMA data during the pre-quit period. | Posted | Mean | Standard Error | units on a scale | During pre-quit period; two weeks |
|
|
|
| 0 |
| 30 |
| 19 |
| 30 |
| EG001 | Placebo Patch | placebo patch given pre-quit from weeks 4 through 6 placebo patch: placebo patch used from weeks 4-6 | 0 | 31 | 15 | 31 |
| Skin irritation at patch placement site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Vivid dreams or nightmares | Psychiatric disorders | Non-systematic Assessment |
|
| Increased PTSD symptoms | Psychiatric disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Elevated blood pressure | Cardiac disorders | Non-systematic Assessment |
|
| Increased heart rate (self-reported) | Cardiac disorders | Non-systematic Assessment |
|
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| D001523 | Mental Disorders |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |