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

NCT ID: NCT01055886

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2014-11-30

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Nicotine Patch

Nicotine patch given pre-quit attempt at weeks 4 through 6

Group Type: ACTIVE_COMPARATOR

nicotine patch

Intervention Type: DRUG

Nicotine patch, 7-21 mg.

placebo patch

placebo patch given pre-quit from weeks 4 through 6

Group Type: PLACEBO_COMPARATOR

placebo patch

Intervention Type: DRUG

placebo patch used from weeks 4-6

Interventions

nicotine patch

Nicotine patch, 7-21 mg.

Intervention Type: DRUG

placebo patch

placebo patch used from weeks 4-6

Intervention Type: DRUG

Other Intervention Names

Nicoderm, Habitrol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick S. Calhoun, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center; Duke University Medical Center

Locations

VA Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00013158

Identifier Type: -

Identifier Source: org_study_id