Nicotine Patch Pretreatment for Smoking Cessation in PTSD
Nicotine Patch Pre-treatment for Smoking Cessation in PTSD
1 other identifier
interventional
87
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started May 2008
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
November 20, 2014
CompletedNovember 20, 2014
November 1, 2014
4.8 years
February 19, 2008
October 28, 2014
November 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Carbon Monoxide Monitoring
Session 12 (6 weeks post-treatment)
Smoking Craving
Daily between visits 2-12
Study Arms (2)
Active Nicotine Patch Group
ACTIVE COMPARATORTransdermal nicotine patch
Placebo Patch Group
PLACEBO COMPARATORTransdermal placebo patch
Interventions
Manualized protocol for CBT in smoking cessation
Antidepressant
Eligibility Criteria
You may qualify if:
- Smokers who smoke 10 or more cigarettes per day in the past year;
- years old;
- English speakers;
- medically stable;
- stable on current medication regimen
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Medical Center, Durham
Durham, North Carolina, 27705, United States
Related Publications (1)
Dedert EA, Dennis PA, Calhoun PS, Dennis MF, Beckham JC. A Randomized Clinical Trial of Nicotine Preloading for Smoking Cessation in People with Posttraumatic Stress Disorder. J Dual Diagn. 2018 Jul-Sep;14(3):148-157. doi: 10.1080/15504263.2018.1468947. Epub 2018 Oct 10.
PMID: 29693495DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela Kirby, MS; Regulatory Coordinator
- Organization
- VA Medical Center, Durham, NC
Study Officials
- PRINCIPAL INVESTIGATOR
Jean C. Beckham, PhD
VA Medical Center, Durham
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2008
First Posted
February 28, 2008
Study Start
May 1, 2008
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
November 20, 2014
Results First Posted
November 20, 2014
Record last verified: 2014-11