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同时使用纳曲酮和延长暴露疗法治疗共病酒精依赖和 PTSD 患者的随机临床试验。

Concurrent naltrexone and prolonged exposure therapy for patients with comorbid alcohol dependence and PTSD: a randomized clinical trial.

机构信息

Department of Psychiatry, University of Pennsylvania, Philadelphia, PA 19104, USA.

出版信息

JAMA. 2013 Aug 7;310(5):488-95. doi: 10.1001/jama.2013.8268.

DOI:10.1001/jama.2013.8268
PMID:23925619
Abstract

IMPORTANCE

Alcohol dependence comorbid with posttraumatic stress disorder (PTSD) has been found to be resistant to treatment. In addition, there is a concern that prolonged exposure therapy for PTSD may exacerbate alcohol use.

OBJECTIVE

To compare the efficacy of an evidence-based treatment for alcohol dependence (naltrexone) plus an evidence-based treatment for PTSD (prolonged exposure therapy), their combination, and supportive counseling.

DESIGN, SETTING, AND PARTICIPANTS: A single-blind, randomized clinical trial of 165 participants with PTSD and alcohol dependence conducted at the University of Pennsylvania and the Philadelphia Veterans Administration. Participant enrollment began on February 8, 2001, and ended on June 25, 2009. Data collection was completed on August 12, 2010.

INTERVENTIONS

Participants were randomly assigned to (1) prolonged exposure therapy plus naltrexone (100 mg/d), (2) prolonged exposure therapy plus pill placebo, (3) supportive counseling plus naltrexone (100 mg/d), or (4) supportive counseling plus pill placebo. Prolonged exposure therapy was composed of 12 weekly 90-minute sessions followed by 6 biweekly sessions. All participants received supportive counseling.

MAIN OUTCOMES AND MEASURES

The Timeline Follow-Back Interview and the PTSD Symptom Severity Interview were used to assess the percentage of days drinking alcohol and PTSD severity, respectively, and the Penn Alcohol Craving Scale was used to assess alcohol craving. Independent evaluations occurred prior to treatment (week 0), at posttreatment (week 24), and at 6 months after treatment discontinuation (week 52).

RESULTS

Participants in all 4 treatment groups had large reductions in the percentage of days drinking (mean change, -63.9% [95% CI, -73.6% to -54.2%] for prolonged exposure therapy plus naltrexone; -63.9% [95% CI, -73.9% to -53.8%] for prolonged exposure therapy plus placebo; -69.9% [95% CI, -78.7% to -61.2%] for supportive counseling plus naltrexone; and -61.0% [95% CI, -68.9% to -53.0%] for supportive counseling plus placebo). However, those who received naltrexone had lower percentages of days drinking than those who received placebo (mean difference, 7.93%; P = .008). There was also a reduction in PTSD symptoms in all 4 groups, but the main effect of prolonged exposure therapy was not statistically significant. Six months after the end of treatment, participants in all 4 groups had increases in percentage of days drinking. However, those in the prolonged exposure therapy plus naltrexone group had the smallest increases.

CONCLUSIONS AND RELEVANCE

In this study of patients with alcohol dependence and PTSD, naltrexone treatment resulted in a decrease in the percentage of days drinking. Prolonged exposure therapy was not associated with an exacerbation of alcohol use disorder.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00006489.

摘要

重要性

已发现酒精依赖合并创伤后应激障碍(PTSD)对治疗有抵抗力。此外,人们担心 PTSD 的延长暴露疗法可能会加重酒精使用。

目的

比较酒精依赖的循证治疗(纳曲酮)和 PTSD 的循证治疗(延长暴露疗法)、它们的组合以及支持性咨询的疗效。

设计、地点和参与者:这是一项在宾夕法尼亚大学和费城退伍军人管理局进行的、针对 165 名患有 PTSD 和酒精依赖的参与者的单盲、随机临床试验。参与者招募于 2001 年 2 月 8 日开始,2009 年 6 月 25 日结束。数据收集于 2010 年 8 月 12 日完成。

干预措施

参与者被随机分配到(1)延长暴露疗法加纳曲酮(100mg/d)、(2)延长暴露疗法加安慰剂丸、(3)支持性咨询加纳曲酮(100mg/d)或(4)支持性咨询加安慰剂丸。延长暴露疗法由 12 次每周 90 分钟的疗程和 6 次双周疗程组成。所有参与者都接受了支持性咨询。

主要结果和测量

时间线随访访谈和 PTSD 症状严重程度访谈分别用于评估饮酒天数的百分比和 PTSD 严重程度,而 Penn 酒精渴求量表用于评估酒精渴求。独立评估在治疗前(第 0 周)、治疗后(第 24 周)和治疗停止后 6 个月(第 52 周)进行。

结果

所有 4 个治疗组的参与者饮酒天数百分比均大幅减少(延长暴露疗法加纳曲酮组的平均变化为-63.9%[95%CI,-73.6%至-54.2%];延长暴露疗法加安慰剂组为-63.9%[95%CI,-73.9%至-53.8%];支持性咨询加纳曲酮组为-69.9%[95%CI,-78.7%至-61.2%];支持性咨询加安慰剂组为-61.0%[95%CI,-68.9%至-53.0%])。然而,接受纳曲酮的参与者的饮酒天数百分比低于接受安慰剂的参与者(平均差异为 7.93%;P=0.008)。所有 4 组的 PTSD 症状也有所减轻,但延长暴露疗法的主要作用并不具有统计学意义。治疗结束后 6 个月,所有 4 组的参与者饮酒天数百分比均有所增加。然而,延长暴露疗法加纳曲酮组的增幅最小。

结论和相关性

在这项针对酒精依赖和 PTSD 患者的研究中,纳曲酮治疗可降低饮酒天数百分比。延长暴露疗法与酒精使用障碍恶化无关。

试验注册

clinicaltrials.gov 标识符:NCT00006489。

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