Results of a Randomized Controlled Trial Examining the Efficacy of Intranasal Oxytocin to Enhance Alcohol Behavioral Couple Therapy.

IF 4.5 2区 医学 Q1 PSYCHIATRY
Julianne C Flanagan, Paul J Nietert, Barbara S McCrady, Stacey Sellers, Anjinetta Yates-Johnson, Sarah T Giff, Shannon R Forkus
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引用次数: 0

Abstract

Objective: This study examined the efficacy of intranasal oxytocin (40 IU), compared to matching placebo (saline), when combined with Alcohol Behavioral Couple Therapy (ABCT) for the treatment of alcohol use disorder (AUD).

Methods: This 12-week clinical trial (2018-2024) utilized a double-blind, randomized, placebo-controlled design. Enrollment occurred from May 2019 to April 2023. Participants were romantic couples (N = 96 dyads; n = 49 oxytocin, n = 47 placebo) consisting of an identified patient (IP) with current AUD per DSM-5 and their partner. Dyads in which both partners had AUD were eligible, and both partners in each dyad were randomized to the same drug condition (ie, placebo or oxytocin). Participants were observed in their medication self-administration 30 minutes prior to ABCT therapy sessions. Primary outcome measures were alcohol consumption (percent days drinking and percent days heavy drinking; Time Line Follow-Back) and relationship functioning (Dyadic Adjustment Scale-Short Form).

Results: All IPs and 50% of partners met diagnostic criteria for AUD; 62 IPs (64.5%) met criteria for severe AUD. Findings from the intent-to-treat analyses indicate that IPs and partners in both conditions evidenced substantial improvements in alcohol consumption and alcohol problem severity but not relationship functioning. No group differences emerged in alcohol consumption, alcohol problem severity, or relationship functioning at end of treatment. Participants completed an average of 10.2 ABCT sessions (SD = 3.5). There were no group differences in the number of medication doses administered or adverse events.

Conclusions: Oxytocin was safe and tolerable but did not provide additional benefit beyond ABCT at the end of treatment. Alternative strategies are necessary to understand oxytocin's potential to facilitate different domains of AUD recovery.

Trial Registration: ClinicalTrials.gov identifier: NCT03046836.

一项检查鼻内催产素增强酒精行为夫妻治疗效果的随机对照试验的结果。
目的:本研究考察了鼻内催产素(40 IU)与相匹配的安慰剂(生理盐水)联合酒精行为夫妇疗法(ABCT)治疗酒精使用障碍(AUD)的疗效。方法:为期12周的临床试验(2018-2024)采用双盲、随机、安慰剂对照设计。入学时间为2019年5月至2023年4月。参与者是浪漫的情侣(N = 96对;n = 49催产素,n = 47安慰剂),由一名确诊的患者(IP)和他们的伴侣组成。夫妻双方都患有AUD的夫妇是符合条件的,每对夫妇中的夫妻都被随机分配到相同的药物条件下(即安慰剂或催产素)。在ABCT治疗前30分钟观察参与者的药物自我管理情况。主要结局指标是饮酒量(饮酒天数百分比和重度饮酒天数百分比;时间线跟踪)和关系功能(二元调整量表-简短形式)。结果:所有的ip和50%的合作伙伴符合AUD的诊断标准;62名患者(64.5%)符合严重澳元的标准。意向治疗分析的结果表明,两种情况下的患者和伴侣在酒精消耗和酒精问题严重程度方面都有实质性改善,但没有关系功能。治疗结束时,在酒精摄入量、酒精问题严重程度或人际关系功能方面没有组间差异。参与者平均完成10.2次ABCT (SD = 3.5)。在给药剂量和不良事件的数量上没有组间差异。结论:催产素是安全且耐受的,但在治疗结束时并没有提供ABCT以外的额外益处。了解催产素促进AUD恢复不同领域的潜力,有必要采取其他策略。试验注册:ClinicalTrials.gov标识符:NCT03046836。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Clinical Psychiatry
Journal of Clinical Psychiatry 医学-精神病学
CiteScore
7.40
自引率
1.90%
发文量
0
审稿时长
3-8 weeks
期刊介绍: For over 75 years, The Journal of Clinical Psychiatry has been a leading source of peer-reviewed articles offering the latest information on mental health topics to psychiatrists and other medical professionals.The Journal of Clinical Psychiatry is the leading psychiatric resource for clinical information and covers disorders including depression, bipolar disorder, schizophrenia, anxiety, addiction, posttraumatic stress disorder, and attention-deficit/hyperactivity disorder while exploring the newest advances in diagnosis and treatment.
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