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NCT01055886 · ClinicalTrials.gov registry record · NA
Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)
A NA study of Smoking Cessation, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT01055886 is a NA study of Smoking Cessation that has completed, run by Duke University. The registered enrollment target is 69 participants, below the 474-participant average among 188 other Smoking Cessation trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01055886, a NA study of Smoking Cessation, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DRUG nicotine patch
- DRUG placebo patch
Study Locations (1)
North Carolina
- VA Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2009-11 |
| Est. Completion | 2014-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01055886
The ClinicalTrials.gov registry entry for NCT01055886 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 474-participant average among 188 other Smoking Cessation trials with a reported enrollment target (85% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Smoking Cessation appearing as the primary indexed condition, and to 2 interventions - of which nicotine patch is the first listed.
NCT01055886 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01055886 about?
NCT01055886 is a clinical study titled "Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (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 ...
What is the current status of trial NCT01055886?
This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2009-11. Estimated completion is 2014-11.
What conditions does trial NCT01055886 study?
This clinical trial studies the following conditions: Smoking Cessation.
What interventions are being tested in trial NCT01055886?
The interventions under investigation include: nicotine patch (DRUG), placebo patch (DRUG).
Who is sponsoring clinical trial NCT01055886?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01055886 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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