Nicotine Patch Pretreatment for Smoking Cessation in PTSD

Tobacco Use Disorder Clinical Trial

Official title:

Nicotine Patch Pre-treatment for Smoking Cessation in PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625131
• Other study ID #: NEUA-007-07F
• Status: Completed
• Phase: Phase 0
• First received: February 19, 2008
• Last updated: November 12, 2014
• Start date: May 2008
• Est. completion date: March 2013

Study information

• Verified date: November 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Stress Disorders, Post-Traumatic
• Stress Disorders, Posttraumatic
• Stress Disorders, Traumatic
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine
Delivered through transdermal nicotine patch

Behavioral:
• Cognitive Behavioral Therapy for Smoking Cessation
Manualized protocol for CBT in smoking cessation

Drug:
• Bupropion Sustained Release (SR)
Antidepressant
• Placebo patch
Pre-treatment placebo transdermal patch

Locations

Country	Name	City	State
United States	VA Medical Center, Durham	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Abstinence, Self-reported	Number of participants by group reporting 1 week of self-reported abstinence in the week prior to Session 12 at six weeks post-treatment	Week prior to Session 12 at 6 weeks post-treatment	No
Secondary	Carbon Monoxide Monitoring	Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment)	Session 12 (6 weeks post-treatment)	No
Secondary	Smoking Craving	Mean smoking craving score (as measured during daily ecological momentary, or diary, assessments) for participants by group during the two week period of placebo/active pre-treatment. This is the main period of interest, as it was hypothesized that use of active nicotine patch would reduce smoking cravings during the pre-quit period. The craving score is based on a single diary item "Please rate your desire to smoke right now" with a Likert scale score ranging from 1 (none) to 5 (severe). Higher craving is "worse," as lower craving is presumed to reflect decreased risk of smoking lapse or relapse.	Daily between visits 2-12	No