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Treatment of Smoking Among Individuals With PTSD

11 oktober 2017 bijgewerkt door: University of Pennsylvania

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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

142

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Integrated Treatment
Prolonged Exposure + Varenicline + Medication Management Counseling
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Andere namen:
  • Cognitieve gedragstherapie
1 mg tablets, orally, twice daily x 12 weeks
Andere namen:
  • Chantix
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
Actieve vergelijker: Varenicline
Varenicline + Medication Management Counseling
1 mg tablets, orally, twice daily x 12 weeks
Andere namen:
  • Chantix
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With 7-day Point Prevalence Smoking Abstinence
Tijdsspanne: At 3-month follow-up (6-month post-quit day)
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.
At 3-month follow-up (6-month post-quit day)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood Serum Cotinine
Tijdsspanne: At end of 3-month follow-up
Level of cotinine in blood
At end of 3-month follow-up
Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment
Tijdsspanne: Post-treatment, occurring 12 weeks after the start of treatment (week 0)

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)
Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up
Tijdsspanne: 3-month follow-up

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
Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment
Tijdsspanne: Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)

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)
Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up
Tijdsspanne: 3-month follow-up

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
TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)
Tijdsspanne: Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit
Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit
TLFB - Cigarettes Smoked Week Before 3-Month Follow-up
Tijdsspanne: 3-month follow-up
Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit
3-month follow-up

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2009

Primaire voltooiing (Werkelijk)

1 december 2015

Studie voltooiing (Werkelijk)

1 december 2015

Studieregistratiedata

Eerst ingediend

8 juli 2009

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2009

Eerst geplaatst (Schatting)

10 juli 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 november 2017

Laatste update ingediend die voldeed aan QC-criteria

11 oktober 2017

Laatst geverifieerd

1 oktober 2017

Meer informatie

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