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.
調査の概要
状態
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania School of Medicine, Dept of Psychiatry, Center for Treatment and Study of Anxiety
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
他の名前：
1 mg tablets, orally, twice daily x 12 weeks
他の名前：
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
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アクティブコンパレータ：Varenicline
Varenicline + Medication Management Counseling
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1 mg tablets, orally, twice daily x 12 weeks
他の名前：
15-minutes weekly counseling x 12 weeks, focused on medication adherence and smoking cessation
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With 7-day Point Prevalence Smoking Abstinence
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Blood Serum Cotinine
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- R01DA023507 (米国 NIH グラント/契約)
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