Helping Veterans Quit Smoking by Improving Their Sleep
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Smoking
In brief
This project is designed to determine whether an efficacious behavioral intervention for insomnia can improve the quit rates achieved by an efficacious smoking cessation program aimed at PTSD patients ("Integrated Care"). A second aim is to deepen our understanding of the mechanisms relating sleep and smoking in PTSD.
Key facts
- Study ID
- NCT01267032
- Run by
- US Department of Veterans Affairs
- People needed
- 142
- Starts
- 2011-10-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2014-12-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Potential participants will be smokers who have smoked at least 10 cigarettes per day for the past year,
- are motivated to make a smoking cessation attempt,
- are na ve to behavioral sleep treatment and are willing to be randomly assigned to either one of the sleep treatment arms.
- Participants must meet the criteria for PTSD and or partial PTSD.
- They will indicate a willingness to forgo the use of all alternative tobacco products during their attempt to quit cigarettes.
- They will be fluent in English.
You may not qualify if…
- Candidates who meet DSM-IV criteria for schizophrenia,
- current manic syndrome,
- lifetime but not current PTSD or partial PTSD,
- or current substance abuse/dependence will be excluded.
- positive Brain Injury Screen will not result in exclusion from the study.
- subjects reporting a prior diagnosis of severe obstructive sleep apnea will be excluded unless they have been successfully treated via weight loss, surgery, or continuous positive airway pressure to which they are reliably adherent.
- We expect these criteria to exclude 15 to 20% of potential participants.
Where it is running
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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