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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01055886
First received: January 24, 2010
Last updated: December 16, 2014
Last verified: November 2013
  Purpose

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.


Condition Intervention
Smoking Cessation
Drug: nicotine patch
Drug: placebo patch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Supplemental Nicotine Administration for Smoking Cessation in PTSD

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Abstinence as Measured by Exhaled Carbon Monoxide (CO) [ Time Frame: Session 12, 6 weeks post-quit ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Diary Ratings of Cravings [ Time Frame: During pre-quit period; two weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 69
Study Start Date: November 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nicotine Patch
Nicotine patch given pre-quit attempt at weeks 4 through 6
Drug: nicotine patch
Nicotine patch, 7-21 mg.
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055886

Locations
United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Patrick S. Calhoun, Ph.D. VA Medical Center; Duke University Medical Center
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01055886     History of Changes
Other Study ID Numbers: Pro00013158
Study First Received: January 24, 2010
Results First Received: December 9, 2014
Last Updated: December 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
PTSD
smoking cessation
nicotine patch

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 26, 2015