Nicotine Patch Pretreatment for Smoking Cessation in PTSD
Study Details
Study Description
Brief Summary
This study seeks to evaluate the relationship between PTSD, abstinence, and factors associated with relapse in the context of a randomized, clinical smoking cessation trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions (active patch versus placebo patch) for three weeks before a target quit-smoking date. All participants to will receive bupropion beginning 1 week prior to their quit day, given that they are medically eligible to be prescribed bupropion. All participants will receive a two session brief cognitive-behavioral therapy (CBT) session and will begin standard nicotine replacement therapy (NRT) on their quit day. PTSD symptoms, mood, and smoking craving will be carefully evaluated throughout the study using electronic diary assessments on personal digital assistants (PDA). Specifically, participants will carefully monitor their symptoms, mood, craving, and use of cigarettes using electronic diaries for one week prior to the pre-cessation period, during the 3-week pre-cessation treatment period, and 6 weeks post quit date. Since no previous study has examined factors associated with smoking abstinence following treatment among PTSD smokers10, predictors of treatment response will be examined.
The study is designed to address the following items:
Specific Aim 1: To evaluate whether supplemental nicotine administration (i.e., pre-cessation treatment with nicotine patch and bupropion) will result in improved quit rates among smokers with PTSD.
Hypothesis 1.1 Supplemental nicotine administration during the pre-cessation period will result in improved quit rates in the first quit week over the placebo patch condition.
Specific Aim 2: To utilize electronic diary assessment of PTSD symptoms, mood, smoking craving, and smoking during baseline, pretreatment, and quit periods to evaluate potential mechanisms of how pretreatment with the nicotine patch may increase abstinence rates.
Hypothesis 2.1 Supplemental nicotine administration will decrease craving for cigarettes during the 2 week pretreatment period as compared to the placebo patch condition.
Hypothesis 2.2 Supplemental nicotine administration will decrease the perceived improvement in mood and PTSD symptoms associated with smoking behavior, i.e., symptom relief from ad lib smoking a cigarette will be reduced during supplemental nicotine administration as compared to the placebo patch condition.
Specific Aim 3: To investigate potential predictors of smoking abstinence and relapse associated with individual differences in affective style including anxiety sensitivity, measures of distress tolerance, and self-efficacy.
Hypothesis 3.1 Increased anxiety sensitivity will be predictive of shorter abstinence from smoking.
Hypothesis 3.2 Decreased distress tolerance will be predictive of shorter abstinence.
Hypothesis 3.3 Lower self-efficacy for smoking abstinence will be predictive of shorter abstinence.
Hypothesis 3.4 Increased PTSD symptoms severity and negative affect following the quit date will be associated with shorter abstinence.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Nicotine Patch Group Transdermal nicotine patch |
Drug: Nicotine
Delivered through transdermal nicotine patch
Behavioral: Cognitive Behavioral Therapy for Smoking Cessation
Manualized protocol for CBT in smoking cessation
Other Names:
Drug: Bupropion Sustained Release (SR)
Antidepressant
Other Names:
|
| Placebo Comparator: Placebo Patch Group Transdermal placebo patch |
Behavioral: Cognitive Behavioral Therapy for Smoking Cessation
Manualized protocol for CBT in smoking cessation
Other Names:
Drug: Bupropion Sustained Release (SR)
Antidepressant
Other Names:
Drug: Placebo patch
Pre-treatment placebo transdermal patch
|
Outcome Measures
Primary Outcome Measures
- Smoking Abstinence, Self-reported [Week prior to Session 12 at 6 weeks post-treatment]
Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment
Secondary Outcome Measures
- Carbon Monoxide Monitoring [Session 12 (6 weeks post-treatment)]
Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment)
- Smoking Craving [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Smokers who smoke 10 or more cigarettes per day in the past year;
-
18-80 years old;
-
English speakers;
-
medically stable;
-
stable on current medication regimen
Exclusion Criteria:
-
Pregnant women excluded;
-
participants with organic mental disorder, schizophrenia, bipolar disorder, lifetime but not current PTSD, current substance abuse or dependence;
-
medical conditions contraindicated with nicotine replacement therapy;
-
use other forms of nicotine (cigars, nicotine gum, etc.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Medical Center, Durham | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- US Department of Veterans Affairs
Investigators
- Principal Investigator: Jean C. Beckham, PhD, VA Medical Center, Durham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NEUA-007-07F
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Active Nicotine Patch Group | Placebo Patch Group | Not Randomized |
|---|---|---|---|
| Arm/Group Description | 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 | Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant | This arm includes patients who met screening criteria for entry into the randomization, but withdrew prior to randomization. |
| Period Title: Overall Study | |||
| STARTED | 38 | 44 | 5 |
| COMPLETED | 34 | 42 | 0 |
| NOT COMPLETED | 4 | 2 | 5 |
Baseline Characteristics
| Arm/Group Title | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Arm/Group Description | 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 | Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant | Total of all reporting groups |
| Overall Participants | 38 | 44 | 82 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
45.16
(9.61)
|
44.48
(11.31)
|
44.79
(10.51)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
17
44.7%
|
21
47.7%
|
38
46.3%
|
| Male |
21
55.3%
|
23
52.3%
|
44
53.7%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
2.6%
|
0
0%
|
1
1.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
21
55.3%
|
30
68.2%
|
51
62.2%
|
| White |
11
28.9%
|
12
27.3%
|
23
28%
|
| More than one race |
4
10.5%
|
2
4.5%
|
6
7.3%
|
| Unknown or Not Reported |
1
2.6%
|
0
0%
|
1
1.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
2
5.3%
|
0
0%
|
2
2.4%
|
| Not Hispanic or Latino |
35
92.1%
|
44
100%
|
79
96.3%
|
| Unknown or Not Reported |
1
2.6%
|
0
0%
|
1
1.2%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
38
100%
|
44
100%
|
82
100%
|
Outcome Measures
| Title | Smoking Abstinence, Self-reported |
|---|---|
| Description | Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment |
| Time Frame | Week prior to Session 12 at 6 weeks post-treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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). |
| Arm/Group Title | Active Nicotine Patch Group | Placebo Patch Group |
|---|---|---|
| Arm/Group Description | 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 | Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant |
| Measure Participants | 38 | 44 |
| Number [participants] |
5
13.2%
|
11
25%
|
| Title | Carbon Monoxide Monitoring |
|---|---|
| Description | Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment) |
| Time Frame | Session 12 (6 weeks post-treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Active Nicotine Patch Group | Placebo Patch Group |
|---|---|---|
| Arm/Group Description | 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 | Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant |
| Measure Participants | 21 | 21 |
| Number [participants] |
8
21.1%
|
5
11.4%
|
| Title | Smoking Craving |
|---|---|
| Description | 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. |
| Time Frame | Daily between visits 2-12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Active Nicotine Patch Group | Placebo Patch Group |
|---|---|---|
| Arm/Group Description | 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 | Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant |
| Measure Participants | 32 | 41 |
| Mean (Standard Deviation) [units on a scale] |
2.48
(1.40)
|
2.59
(1.24)
|
Adverse Events
| Time Frame | 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. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Active Nicotine Patch Group | Placebo Patch Group | ||
| Arm/Group Description | 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 | Transdermal placebo patch Cognitive Behavioral Therapy for Smoking Cessation: Manualized protocol for CBT in smoking cessation Bupropion SR: Antidepressant | ||
All Cause Mortality |
||||
| Active Nicotine Patch Group | Placebo Patch Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Active Nicotine Patch Group | Placebo Patch Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/38 (0%) | 2/44 (4.5%) | ||
| Blood and lymphatic system disorders | ||||
| Hospitalization for preexisting circulatory disorder | 0/38 (0%) | 0 | 1/44 (2.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Hospitalization for pre-existing Chronic Obstructive Pulmonary Disease (COPD) | 0/38 (0%) | 0 | 1/44 (2.3%) | 2 |
Other (Not Including Serious) Adverse Events |
||||
| Active Nicotine Patch Group | Placebo Patch Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/38 (31.6%) | 16/44 (36.4%) | ||
| Gastrointestinal disorders | ||||
| nausea | 0/38 (0%) | 0 | 4/44 (9.1%) | 6 |
| Dry mouth | 3/38 (7.9%) | 3 | 0/44 (0%) | 0 |
| Gas and/or hemorrhoid pain | 2/38 (5.3%) | 4 | 0/44 (0%) | 0 |
| General disorders | ||||
| Surgical Intervention, non-study related | 3/38 (7.9%) | 3 | 2/44 (4.5%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| Orthopedic accident, not study related | 0/38 (0%) | 0 | 2/44 (4.5%) | 2 |
| Psychiatric disorders | ||||
| Exacerbation of pre-existing PTSD symptoms | 4/38 (10.5%) | 4 | 7/44 (15.9%) | 7 |
| Sleep disturbance and/or increased nightmares | 7/38 (18.4%) | 7 | 2/44 (4.5%) | 2 |
| Skin and subcutaneous tissue disorders | ||||
| Itching and/or skin rash at site of patch placement | 6/38 (15.8%) | 6 | 3/44 (6.8%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Angela Kirby, MS; Regulatory Coordinator |
|---|---|
| Organization | VA Medical Center, Durham, NC |
| Phone | 9192860411 ext 5526 |
| angela.kirby@va.gov |
- NEUA-007-07F