View Clinical Trial (Medical Research Study)
Improving Smoking Cessation Outcomes in PTSD With CBT for Insomnia
| City: |
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Palo Alto |
| State: |
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California |
| Zip Code: |
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94304 |
| Conditions: |
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Smoking |
| Purpose: |
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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.
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| Study Summary: |
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In summary, participation will involve a screening period of approximately one week, six
weeks of temporally aligned IC ("Integrated Care" - manualized smoking cessation treatment
integrating components of behavioral treatment for PTSD) and behavioral sleep treatments
(Cognitive-Behavioral Treatment for Insomnia or CBTI), and follow-up telephone interviews at
two months and six months.
Screening: Patients in the VA Palo Alto inpatient psychiatry and domiciliary programs
indicating interest in quitting cigarette smoking will be pre-screened by the Medical
Director to determine whether an individual's psychiatric conditions contraindicates use of
bupropion or NRT (Nicoderm). Patients interested in quitting will be referred to the study
coordinator. Coordinator will be notified whether medication or NRT is contraindicated for
participant and/or of a diagnosed sleep disorder (treated or untreated) other than insomnia.
Continuing participants will be consented and then complete 24 hours of cued symptom
reporting using a personal digital assistant (PDA) to verify their capacity to adhere to
this component of the study protocol. Continuing participants will undergo a research
psychodiagnostic assessment followed by an ambulatory screening polysomnogram (PSG) to
exclude undiagnosed sleep disorders. (Participants exhibiting evidence of sleep disorder
will be referred for a clinical sleep study.) Screening assessments and psychodiagnostics
have been sequenced with the aim of minimizing burden for those excluded.
Participants meeting all inclusion and exclusion criteria will be randomized to IC+CBTI or
IC+Desensitization Treatment for Insomnia (DTI: a manualized placebo control intervention).
They will meet twice with the IC therapist to complete IC sessions 1 and 2. Over the course
of these sessions, they will negotiate a quit date at least three weeks from that time and
at least four weeks prior to their projected discharge from inpatient treatment. (Inpatient
stays in both of these programs average thirteen weeks.) IC sessions 3 and 4 will be evenly
spaced between IC session 2 and the planned quit date. Three weeks prior to their quit date,
they will initiate sleep treatment (sessions 1 and 2) and nightly mattress actigraphy. Two
weeks prior to their quit date they will begin PDA-based EMA. One to two weeks prior to
their quit date, they will commence bupropion and receive sleep treatment session 3. One
week prior to their quit date they will receive sleep treatment session 4. On their quit
date they will begin NRT. Thereafter, for weeks four through six, they will receive IC
sessions five through eight and sleep treatment session five through seven, respectively. At
the end of week six, they will receive IC session eight which will also serve as the 3 week
assessment of smoking status (the primary outcome assessment of the study). (Note that the
first planned assessment of cessation status will occur prior to the expected discharge date
for all participants.) The final research interventions will be telephone interviews at two
months and six months. Salivary cotinine samples will be obtained at the end of each
post-quit week (only if the participant is not using NRT) the last corresponding to the
primary outcome assessment, at both telephone follow-up smoking status assessments (by
mail).
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| Criteria: |
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Inclusion Criteria:
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.
Exclusion Criteria:
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. A 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.
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| NCT ID: |
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NCT01267032 |
| Primary Contact: |
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Principal Investigator
Steven H. Woodward, PhD
VA Palo Alto Health Care System, Palo Alto, CA
Steven H Woodward, PhD
Email: steve.woodward@va.gov
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| Backup Contact: |
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Email: cindie.slightam@va.gov
Cindie Slightam, MPH BS
Phone: (650) 493-5000 ext. 27378
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| Location Contact: |
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Palo Alto, California 94304
United States
Steven H Woodward, PhD
Email: steve.woodward@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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