Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Smoking Cessation |
Drug: nicotine patch Drug: placebo patch |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Supplemental Nicotine Administration for Smoking Cessation in PTSD |
- participant self-report of smoking cessation [ Time Frame: weeks 7-12; 6 months ] [ Designated as safety issue: No ]
- exhaled carbon monoxide [ Time Frame: weeks 7-12; 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 81 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Nicotine Patch
Nicotine patch given pre-quit attempt at weeks 4 through 6
|
Drug: nicotine patch
Nicotine patch, 7-21 mg.
Other Name: Nicoderm, Habitrol
|
|
Placebo Comparator: placebo patch
placebo patch given pre-quit from weeks 4 through 6
|
Drug: placebo patch
placebo patch used from weeks 4-6
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| United States, North Carolina | |
| VA Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| Principal Investigator: | Patrick S. Calhoun, Ph.D. | VA Medical Center; Duke University Medical Center |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01055886 History of Changes |
| Other Study ID Numbers: | Pro00013158 |
| Study First Received: | January 24, 2010 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
PTSD smoking cessation nicotine patch |
Additional relevant MeSH terms:
|
Smoking Stress Disorders, Post-Traumatic Habits Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013