Treatment of Smoking Among Individuals With PTSD
Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up.
We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Male or female treatment-seeking cigarette smokers between 18-75 years old who smoke an average of ≥10 cigarettes/day during past year;
- Current diagnosis of chronic PTSD (symptom duration > 3 months) with clinically significant trauma-related symptoms (PSS-I >= 20)
- Live a commutable distance to the University of Pennsylvania and agree to follow-up visits;
- Agree not to use other forms of smoking cessation treatment or treatment for PTSD during the study period;
- If taking SRIs or other medications at intake, have been on stable medication and dose regimen for past 3 months and agree to maintain current regimen if possible;
- Demonstrate the capacity to provide informed consent;
- Speak and read English.
Exclusion Criteria:
- History of drug or alcohol abuse or dependence in past 3 months or any unwillingness to not smoke marijuana during the first 13 weeks of the study;
- Current and continuing intimate relationship with a physically or sexually abusive partner;
- Current suicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment;
- Prior serious suicide attempt, as judged by the evaluator to have a high degree of lethality;
- Current or past history of psychosis (bipolar disorder or schizophrenia);
- History of significant cardiovascular disease or uncontrolled hypertension in past 6 months;
- Women who are pregnant, likely to become pregnant (i.e., sexually active and not using contraception), or nursing.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Integrated Treatment
Prolonged Exposure + Varenicline + Medication Management Counseling
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75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Andre navne:
1 mg tablets, orally, twice daily x 12 weeks
Andre navne:
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
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Aktiv komparator: Varenicline
Varenicline + Medication Management Counseling
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1 mg tablets, orally, twice daily x 12 weeks
Andre navne:
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With 7-day Point Prevalence Smoking Abstinence
Tidsramme: At 3-month follow-up (6-month post-quit day)
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Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of <15ng/ml, and CO < 10 ppm.
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At 3-month follow-up (6-month post-quit day)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Blood Serum Cotinine
Tidsramme: At end of 3-month follow-up
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Level of cotinine in blood
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At end of 3-month follow-up
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Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment
Tidsramme: Post-treatment, occurring 12 weeks after the start of treatment (week 0)
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Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51. Higher scores indicate higher/worse levels of PTSD. |
Post-treatment, occurring 12 weeks after the start of treatment (week 0)
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Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up
Tidsramme: 3-month follow-up
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Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51. Higher scores indicate higher/worse levels of PTSD. |
3-month follow-up
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Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment
Tidsramme: Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)
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Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50. Higher scores indicate higher/worse levels of depression. |
Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)
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Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up
Tidsramme: 3-month follow-up
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Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50. Higher scores indicate higher/worse levels of depression. |
3-month follow-up
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TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)
Tidsramme: Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
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Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit
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Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
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TLFB - Cigarettes Smoked Week Before 3-Month Follow-up
Tidsramme: 3-month follow-up
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Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit
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3-month follow-up
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme 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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
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
- Kolinerge midler
- Nikotiniske agonister
- Kolinerge agonister
- Vareniclin
Andre undersøgelses-id-numre
- R01DA023507 (U.S. NIH-bevilling/kontrakt)
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Kliniske forsøg med Prolonged Exposure
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University of ZurichBeijing Normal University; Jichi Medical UniversityTrukket tilbage