- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00625131
Nicotine Patch Pretreatment for Smoking Cessation in PTSD
Nicotine Patch Pre-treatment for Smoking Cessation in PTSD
Studieoversigt
Status
Detaljeret beskrivelse
Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions (active patch versus placebo patch) for three weeks before a target quit-smoking date. All participants to will receive bupropion beginning 1 week prior to their quit day, given that they are medically eligible to be prescribed bupropion. All participants will receive a two session brief cognitive-behavioral therapy (CBT) session and will begin standard nicotine replacement therapy (NRT) on their quit day. PTSD symptoms, mood, and smoking craving will be carefully evaluated throughout the study using electronic diary assessments on personal digital assistants (PDA). Specifically, participants will carefully monitor their symptoms, mood, craving, and use of cigarettes using electronic diaries for one week prior to the pre-cessation period, during the 3-week pre-cessation treatment period, and 6 weeks post quit date. Since no previous study has examined factors associated with smoking abstinence following treatment among PTSD smokers10, predictors of treatment response will be examined. The study is designed to address the following items:
Specific Aim 1: To evaluate whether supplemental nicotine administration (i.e., pre-cessation treatment with nicotine patch and bupropion) will result in improved quit rates among smokers with PTSD.
Hypothesis 1.1 Supplemental nicotine administration during the pre-cessation period will result in improved quit rates in the first quit week over the placebo patch condition.
Specific Aim 2: To utilize electronic diary assessment of PTSD symptoms, mood, smoking craving, and smoking during baseline, pretreatment, and quit periods to evaluate potential mechanisms of how pretreatment with the nicotine patch may increase abstinence rates.
Hypothesis 2.1 Supplemental nicotine administration will decrease craving for cigarettes during the 2 week pretreatment period as compared to the placebo patch condition.
Hypothesis 2.2 Supplemental nicotine administration will decrease the perceived improvement in mood and PTSD symptoms associated with smoking behavior, i.e., symptom relief from ad lib smoking a cigarette will be reduced during supplemental nicotine administration as compared to the placebo patch condition.
Specific Aim 3: To investigate potential predictors of smoking abstinence and relapse associated with individual differences in affective style including anxiety sensitivity, measures of distress tolerance, and self-efficacy.
Hypothesis 3.1 Increased anxiety sensitivity will be predictive of shorter abstinence from smoking.
Hypothesis 3.2 Decreased distress tolerance will be predictive of shorter abstinence.
Hypothesis 3.3 Lower self-efficacy for smoking abstinence will be predictive of shorter abstinence.
Hypothesis 3.4 Increased PTSD symptoms severity and negative affect following the quit date will be associated with shorter abstinence.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27705
- VA Medical Center, Durham
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Smokers who smoke 10 or more cigarettes per day in the past year;
- 18-80 years old;
- English speakers;
- medically stable;
- stable on current medication regimen
Exclusion Criteria:
- 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.)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Active Nicotine Patch Group
Transdermal nicotine patch
|
Delivered through transdermal nicotine patch
Manualized protocol for CBT in smoking cessation
Andre navne:
Antidepressant
Andre navne:
|
Placebo komparator: Placebo Patch Group
Transdermal placebo patch
|
Manualized protocol for CBT in smoking cessation
Andre navne:
Antidepressant
Andre navne:
Pre-treatment placebo transdermal patch
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Smoking Abstinence, Self-reported
Tidsramme: Week prior to Session 12 at 6 weeks post-treatment
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Carbon Monoxide Monitoring
Tidsramme: Session 12 (6 weeks post-treatment)
|
Number of participants whose carbon monoxide (CO) measurement indicated abstinence at Session 12 (6 weeks post-treatment)
|
Session 12 (6 weeks post-treatment)
|
Smoking Craving
Tidsramme: Daily between visits 2-12
|
Mean smoking craving score (as measured during daily ecological momentary, or diary, assessments) for participants by group during the two week period of placebo/active pre-treatment.
This is the main period of interest, as it was hypothesized that use of active nicotine patch would reduce smoking cravings during the pre-quit period.
The craving score is based on a single diary item "Please rate your desire to smoke right now" with a Likert scale score ranging from 1 (none) to 5 (severe).
Higher craving is "worse," as lower craving is presumed to reflect decreased risk of smoking lapse or relapse.
|
Daily between visits 2-12
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jean C. Beckham, PhD, VA Medical Center, Durham
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Kemisk inducerede lidelser
- Patologiske processer
- Stof-relaterede lidelser
- Traumer og stressor-relaterede lidelser
- Sygdom
- Stresslidelser, traumatiske
- Stresslidelser, posttraumatisk
- Tobaksbrugsforstyrrelse
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Enzymhæmmere
- Psykotropiske stoffer
- Neurotransmitter optagelseshæmmere
- Membrantransportmodulatorer
- Antidepressive midler
- Dopaminmidler
- Cytokrom P-450 enzymhæmmere
- Ganglionstimulerende midler
- Nikotiniske agonister
- Kolinerge agonister
- Antidepressive midler, anden generation
- Cytokrom P-450 CYP2D6-hæmmere
- Dopaminoptagelseshæmmere
- Nikotin
- Bupropion
Andre undersøgelses-id-numre
- NEUA-007-07F
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Nicotine
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Aktiv, ikke rekrutterende