按需经鼻给予纳洛酮治疗赌博障碍：一项评估可接受性、可行性和结局的初步研究。
Treating gambling disorder with as needed administration of intranasal naloxone: a pilot study to evaluate acceptability, feasibility and outcomes.
机构信息
Department of Public Health Solutions, Terveyden ja hyvinvoinnin laitos, Helsinki, Finland.
Faculty of Social Science, Department of Psychology and Speech Language Pathology, Turun Yliopisto, Turku, Finland.
出版信息
BMJ Open. 2019 Aug 21;9(8):e023728. doi: 10.1136/bmjopen-2018-023728.
BACKGROUND AND AIM
There is growing interest in the use of medication-assisted treatments for gambling disorder (GD). Opioid receptor antagonists are hypothesised to blunt the craving associated with gambling. This study was designed to assess the feasibility of using an intranasal naloxone spray to treat GD.
DESIGN
An 8-week, open-label, uncontrolled pilot study.
SETTING
A single study site in the capital region of Finland.
SUBJECTS
Twenty problem gamblers (nine men) were randomised into two groups. Group A (n=10) took one dose into one nostril (2 mg naloxone), as needed, with a maximum of 4 doses/day (max. 8 mg/day). Group B (n=10) took one dose into each nostril (4 mg naloxone) as needed, with a maximum of 4 doses/day (max. 16 mg/day).
INTERVENTION
Naloxone hydrochloride nasal spray.
MEASURES
Acceptability and feasibility of the intervention were assessed. Use of study medication, adverse events, gambling frequency and gambling expenditure were recorded in a mobile diary. Problem gambling: South Oaks Gambling Screen (SOGS), depressive symptoms: Beck Depression Inventory (BDI) and alcohol use: Alcohol Use Disorders Identification Test were recorded.
RESULTS
Study completion rate was 90%. Acceptability and feasibility scores were high. Group B used intranasal naloxone more frequently than group A, and consequently used more naloxone. No serious adverse events were reported. The postintervention SOGS scores were lower (median=4 (IQR=3.75) versus preintervention scores (median=12 (IQR=4.75)). Depressive symptoms were reduced during the trial (preintervention BDI median=9, IQR=9 vs postintervention BDI median=6, IQR=6).
CONCLUSIONS
The acceptability and feasibility of using intranasal naloxone were high, and no serious adverse events were reported. Preliminary results suggest mixed results in terms of gambling behaviour (ie, reduced frequency but not expenditure) and decreased depressive symptoms.
TRIAL REGISTRATION NUMBER
EudraCT2016-001828-56.
背景与目的
人们对使用药物辅助治疗赌博障碍（GD）越来越感兴趣。阿片受体拮抗剂被假设可以减轻与赌博相关的渴望。本研究旨在评估使用纳洛酮鼻腔喷雾剂治疗 GD 的可行性。
设计
一项为期 8 周、开放标签、非对照的试点研究。
地点
芬兰首都地区的一个单一研究地点。
受试者
20 名问题赌徒（9 名男性）被随机分为两组。A 组（n=10）按需将一剂（2mg 纳洛酮）喷入一个鼻孔，每天最多 4 剂（每天最多 8mg）。B 组（n=10）按需将一剂（4mg 纳洛酮）喷入每个鼻孔，每天最多 4 剂（每天最多 16mg）。
干预措施
盐酸纳洛酮鼻腔喷雾剂。
措施
评估干预措施的可接受性和可行性。在移动日记中记录研究药物的使用情况、不良事件、赌博频率和赌博支出。问题赌博：南奥克斯赌博筛查（SOGS）、抑郁症状：贝克抑郁量表（BDI）和酒精使用：酒精使用障碍识别测试。
结果
研究完成率为 90%。可接受性和可行性评分均较高。B 组比 A 组更频繁地使用鼻腔内纳洛酮，因此使用了更多的纳洛酮。未报告严重不良事件。干预后的 SOGS 评分较低（中位数=4（IQR=3.75）与干预前的评分（中位数=12（IQR=4.75）。在试验过程中，抑郁症状减轻（干预前 BDI 中位数=9，IQR=9 与干预后 BDI 中位数=6，IQR=6）。
结论
使用鼻腔内纳洛酮的可接受性和可行性较高，未报告严重不良事件。初步结果表明，在赌博行为方面（即频率降低但支出没有降低）和抑郁症状减轻方面的结果喜忧参半。
试验注册号
EudraCT2016-001828-56。
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