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

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:

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 Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: nicotine patch; Drug: placebo patch

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nicotine Patch; Nicotine patch given pre-quit attempt at weeks 4 through 6	Drug: nicotine patch; Nicotine patch, 7-21 mg.; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Session 12, 6 weeks post-quit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diary Ratings of Cravings	Participants provided (through ecological momentary assessment) ratings of their smoking craving. This outcome reflects differences between ad lib (or typical) smoking craving compared to smoking craving reported during the pre-quit period. Craving was reported from a single item "Please indicate your desire/craving to smoke," and answers were provided in a 5-point Likert scale where 1=no craving and 5=severe craving. Higher scores are presumed to be "worse" because they indicate increased craving, which is likely to lead to non-abstinence.	During pre-quit period; two weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Patrick S. Calhoun, Ph.D., VA Medical Center; Duke University Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: January 24, 2010
• First Submitted That Met QC Criteria: January 25, 2010
• First Posted (ESTIMATE): January 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 6, 2015
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: PTSD; smoking cessation; nicotine patch
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: Pro00013158