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

NCT01055886 | Completed Results DMC

• 1 other identifier: Pro00013158
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Keywords

PTSD; smoking cessation; nicotine patch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Abstinence as Measured by Exhaled Carbon Monoxide (CO)

  Session 12, 6 weeks post-quit

Other Outcomes (1)

• Diary Ratings of Cravings

  During pre-quit period; two weeks

Study Arms (2)

Nicotine Patch

ACTIVE COMPARATOR

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

Drug: nicotine patch

placebo patch

PLACEBO COMPARATOR

placebo patch given pre-quit from weeks 4 through 6

Drug: placebo patch

Interventions

nicotine patch DRUG

Nicotine patch, 7-21 mg.

Also known as: Nicoderm, Habitrol

Nicotine Patch

placebo patch DRUG

placebo patch used from weeks 4-6

placebo patch

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

VA Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Stress Disorders, Post-Traumatic

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Angela Kirby
• Organization: VA Medical Center

angela.kirby@va.gov

919-286-0411

Study Officials

• Patrick S. Calhoun, Ph.D.

  VA Medical Center; Duke University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2010
• First Posted: January 26, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 6, 2015
• Results First Posted: December 15, 2014

Record last verified: 2013-11

Locations

US (1)