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Nicotine Patch Pretreatment for Smoking Cessation in PTSD

NCT ID: NCT00625131

Last Updated: 2014-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Stress Disorders, Posttraumatic Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Nicotine Patch Group

Transdermal nicotine patch

Group Type ACTIVE_COMPARATOR

Nicotine

Intervention Type DRUG

Delivered through transdermal nicotine patch

Cognitive Behavioral Therapy for Smoking Cessation

Intervention Type BEHAVIORAL

Manualized protocol for CBT in smoking cessation

Bupropion Sustained Release (SR)

Intervention Type DRUG

Antidepressant

Placebo Patch Group

Transdermal placebo patch

Group Type PLACEBO_COMPARATOR

Cognitive Behavioral Therapy for Smoking Cessation

Intervention Type BEHAVIORAL

Manualized protocol for CBT in smoking cessation

Bupropion Sustained Release (SR)

Intervention Type DRUG

Antidepressant

Placebo patch

Intervention Type DRUG

Pre-treatment placebo transdermal patch

Interventions

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Nicotine

Delivered through transdermal nicotine patch

Intervention Type DRUG

Cognitive Behavioral Therapy for Smoking Cessation

Manualized protocol for CBT in smoking cessation

Intervention Type BEHAVIORAL

Bupropion Sustained Release (SR)

Antidepressant

Intervention Type DRUG

Placebo patch

Pre-treatment placebo transdermal patch

Intervention Type DRUG

Other Intervention Names

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CBT Zyban, Wellbutrin

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean C. Beckham, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Durham

Locations

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VA Medical Center, Durham

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29693495 (View on PubMed)

Other Identifiers

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NEUA-007-07F

Identifier Type: -

Identifier Source: org_study_id