Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: nicotine patch; Drug: placebo patch

• Registration Number: NCT01055886
• Lead Sponsor: Duke University

Brief 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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-24
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Status Verified: 2013-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2014-12-09
• Results First Submitted QC: 2014-12-09
• Results First Posted: 2014-12-15
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2015-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Patch	nicotine patch	Nicotine patch given pre-quit attempt at weeks 4 through 6
placebo patch	placebo patch	placebo patch given pre-quit from weeks 4 through 6

Primary Outcome Measures

Name	Time	Method
Participants Self-reporting Abstinence During 6 Weeks Post Quit	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.

Secondary Outcome Measures

Name	Time	Method
Abstinence as Measured by Exhaled Carbon Monoxide (CO)	Session 12, 6 weeks post-quit	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.

Trial Locations

Locations (1)

VA Medical Center; 🇺🇸 Durham, North Carolina, United States