Stress Disorders, PosttraumaticEarly Phase 1NCT00625131
Nicotine Patch Pretreatment for Smoking Cessation in PTSD
A Early Phase 1 study testing Nicotine, Cognitive Behavioral Therapy for Smoking Cessation and Bupropion Sustained Release (SR) in people with Stress Disorders, Posttraumatic and Tobacco Use Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Posttraumatic, Tobacco Use Disorder
- What is being tested?
- Nicotine, Cognitive Behavioral Therapy for Smoking Cessation and Bupropion Sustained Release (SR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Mar 2013
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Durham
Durham, North Carolina, 27705
About this study
Official title: Nicotine Patch Pre-treatment for Smoking Cessation in PTSD
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.
Read the 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.
- Being tested
- Nicotine, Cognitive Behavioral Therapy for Smoking Cessation, Bupropion Sustained Release (SR), Placebo patch
- Keywords
- Stress Disorders, Posttraumatic, Tobacco Use Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Delivered through transdermal nicotine patch
Cognitive Behavioral Therapy for Smoking CessationBehavioural
Also called CBT
Manualized protocol for CBT in smoking cessation
Bupropion Sustained Release (SR)Drug
Also called Zyban, Wellbutrin
Antidepressant
Placebo patchDrug
Pre-treatment placebo transdermal patch
| Study group | Role | What they receive |
|---|---|---|
| Active Nicotine Patch Group | Active comparator | Transdermal nicotine patch Receives: Drug: Nicotine; Behavioral: Cognitive Behavioral Therapy for Smoking Cessation; Drug: Bupropion Sustained Release (SR) |
| Placebo Patch Group | Placebo comparator | Transdermal placebo patch Receives: Behavioral: Cognitive Behavioral Therapy for Smoking Cessation; Drug: Bupropion Sustained Release (SR); Drug: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence, Self-reported
Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment
Measured: Week prior to Session 12 at 6 weeks post-treatment
Secondary outcomes (2)
Carbon Monoxide Monitoring
Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment)
Measured: Session 12 (6 weeks post-treatment)
Smoking Craving
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.
Measured: Daily between visits 2-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, PosttraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jean C. Beckham, PhD, Principal investigator, VA Medical Center, Durham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625131
- Sponsor's protocol ID
- NEUA-007-07F
- Status last verified
- Nov 2014
- First submitted
- 19 Feb 2008
- Last updated
- 20 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dedert EA, Dennis PA, Calhoun PS, Dennis MF, Beckham JC. A Randomized Clinical Trial of Nicotine Preloading for Smoking Cessation in People with Posttraumatic Stress Disorder. J Dual Diagn. 2018 Jul-Sep;14(3):148-157. doi: 10.1080/15504263.2018.1468947. Epub 2018 Oct 10.
PubMed 29693495
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Patch Pre-treatment for Smoking Cessation in PTSD
- ClinicalTrials.gov ID
- NCT00625131
- Acronym / sponsor ID
- NEUA-007-07F
- Keywords
- Stress Disorders, Posttraumatic, Tobacco Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Nicotine Patch Group | Active comparator | Drug: Nicotine, Behavioral: Cognitive Behavioral Therapy for Smoking Cessation, Drug: Bupropion Sustained Release (SR)Transdermal nicotine patch |
| Placebo Patch Group | Placebo comparator | Behavioral: Cognitive Behavioral Therapy for Smoking Cessation, Drug: Bupropion Sustained Release (SR), Drug: Placebo patchTransdermal placebo patch |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotineDelivered through transdermal nicotine patch | Drug | Active Nicotine Patch Group |
| Cognitive Behavioral Therapy for Smoking CessationAlso: CBTManualized protocol for CBT in smoking cessation | Behavioural | Active Nicotine Patch Group, Placebo Patch Group |
| Bupropion Sustained Release (SR)Also: Zyban, WellbutrinAntidepressant | Drug | Active Nicotine Patch Group, Placebo Patch Group |
| Placebo patchPre-treatment placebo transdermal patch | Drug | Placebo Patch Group |
Primary outcome
Smoking Abstinence, Self-reported
Time frame: 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
2 secondary outcomes
Carbon Monoxide Monitoring
Time frame: Session 12 (6 weeks post-treatment)
Smoking Craving
Time frame: Daily between visits 2-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29693495Dedert EA, Dennis PA, Calhoun PS, Dennis MF, Beckham JC. A Randomized Clinical Trial of Nicotine Preloading for Smoking Cessation in People with Posttraumatic Stress Disorder. J Dual Diagn. 2018 Jul-Sep;14(3):148-157. doi: 10.1080/15504263.2018.1468947. Epub 2018 Oct 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean C. Beckham, PhD principal investigator
VA Medical Center, Durham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nicotine, Cognitive Behavioral Therapy for Smoking Cessation and Bupropion Sustained Release (SR) in people with Stress Disorders, Posttraumatic and Tobacco Use Disorder, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Abstinence, Self-reported (time frame: Week prior to Session 12 at 6 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00625131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.