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.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
다른 이름들:
1 mg tablets, orally, twice daily x 12 weeks
다른 이름들:
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
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활성 비교기: Varenicline
Varenicline + Medication Management Counseling
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1 mg tablets, orally, twice daily x 12 weeks
다른 이름들:
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With 7-day Point Prevalence Smoking Abstinence
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood Serum Cotinine
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- R01DA023507 (미국 NIH 보조금/계약)
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Prolonged Exposure에 대한 임상 시험
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Tri-Service General Hospital아직 모집하지 않음외상 후 스트레스 장애(PTSD) | 우울증 - 주요 우울 장애대만