Smoking CessationNCT01055886
Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)
A study testing nicotine patch in people with Smoking Cessation, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- nicotine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2014
- Phase
- Interventional
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplemental Nicotine Administration for Smoking Cessation in PTSD
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:
Read more
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.
- Conditions
- Smoking Cessation
- Being tested
- nicotine patch, placebo patch
- Keywords
- PTSD, smoking cessation, nicotine patch
- Medical subject headings
- Smoking Cessation, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine patchDrug
Also called Nicoderm, Habitrol
Nicotine patch, 7-21 mg.
placebo patchDrug
placebo patch used from weeks 4-6
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Patch | Active comparator | Nicotine patch given pre-quit attempt at weeks 4 through 6 Receives: Drug: nicotine patch |
| placebo patch | Placebo comparator | placebo patch given pre-quit from weeks 4 through 6 Receives: Drug: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12
Secondary outcomes (1)
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.
Measured: Session 12, 6 weeks post-quit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2014
- Study completionNov 2014
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.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick S. Calhoun, Ph.D., Principal investigator, VA Medical Center; Duke University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055886
- Sponsor's protocol ID
- Pro00013158
- Status last verified
- Nov 2013
- First submitted
- 24 Jan 2010
- Last updated
- 6 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Nicotine Administration for Smoking Cessation in PTSD
- ClinicalTrials.gov ID
- NCT01055886
- Acronym / sponsor ID
- Pro00013158
- Conditions
- Smoking Cessation
- Keywords
- PTSD, smoking cessation, nicotine patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 15 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine Patch | Active comparator | Drug: nicotine patchNicotine patch given pre-quit attempt at weeks 4 through 6 |
| placebo patch | Placebo comparator | Drug: placebo patchplacebo patch given pre-quit from weeks 4 through 6 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| nicotine patchAlso: Nicoderm, HabitrolNicotine patch, 7-21 mg. | Drug | Nicotine Patch |
| placebo patchplacebo patch used from weeks 4-6 | Drug | placebo patch |
Primary outcome
Participants Self-reporting Abstinence During 6 Weeks Post Quit
Time frame: 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.
1 secondary outcome
Abstinence as Measured by Exhaled Carbon Monoxide (CO)
Time frame: Session 12, 6 weeks post-quit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Patrick S. Calhoun, Ph.D. principal investigator
VA Medical Center; Duke University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nicotine patch in people with Smoking Cessation, run by Duke University 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 6 Jan 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 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?
Participants Self-reporting Abstinence During 6 Weeks Post Quit (time frame: 6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2015.