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Completed

NCT Number: NCT01055886

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 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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch

Drug

Nicotine patch, 7-21 mg.

Other names: Nicoderm, Habitrol

Placebo Patch

Drug

placebo patch used from weeks 4-6

Primary outcomes

  1. Participants Self-reporting Abstinence During 6 Weeks Post Quit

    Time frame: 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 outcomes

  1. Abstinence as Measured by Exhaled Carbon Monoxide (CO)

    Time frame: 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.

Other outcomes

  1. Diary Ratings of Cravings

    Time frame: During pre-quit period; two weeks

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Supplemental Nicotine Administration for Smoking Cessation in PTSD

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2010
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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