Interventions Précoces en Addictologie Dans le Cadre Des Urgences Par Intoxications aiguës Aux Stupéfiants (IPAIS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 266
- 试验地点
- 4
- 主要终点
- Retention in addiction care at 6 months
研究概览
简要总结
Acute intoxication with psychoactive substances represents a major public health issue and a frequent reason for emergency department (ED) visits. Beyond the acute medical management of intoxication, one of the main challenges remains the continuity of addiction care after discharge. Many patients disengage rapidly from follow-up services, leading to recurrent intoxication episodes, repeated ED admissions, and increased morbidity.
The IPAIS study (Interventions Précoces en Addictologie dans le cadre des urgences par Intoxications aiguës aux Stupéfiants) is a multicenter, randomized, parallel-group, open-label clinical trial designed to evaluate whether an enhanced early addiction care pathway improves retention in addiction treatment among patients admitted to emergency departments for acute intoxication involving at least one illicit psychoactive substance (excluding isolated alcohol intoxication).
All participants will receive an early addiction consultation within 24 to 72 hours following the acute event. In the experimental group, this consultation will be combined with a structured and standardized feedback session on toxicological analysis results and a proactive follow-up strategy including scheduled telephone contacts over a 6-month period. The control group will receive early addiction consultation according to usual care procedures, without the structured feedback and standardized follow-up program implemented in the experimental arm.
The primary objective of the study is to determine whether the enhanced intervention improves retention in the addiction care pathway at 6 months after inclusion. Retention is defined as sustained engagement in addiction care, operationalized as at least one addiction-related consultation per month and/or regular telephone-based addiction follow-up over the 6-month period.
详细描述
Acute intoxication with psychoactive substances is a major public health issue and a frequent reason for emergency department visits. Beyond the acute medical management of intoxication, a key challenge remains ensuring continuity of addiction care after discharge. Many patients quickly disengage from follow-up services, leading to recurrent episodes of intoxication, repeated emergency department admissions, and increased morbidity.
The IPAIS study (Early Addiction Interventions in Emergency Settings for Acute Intoxication with Illicit Drugs) is a multicenter, randomized, parallel-group, open-label clinical trial designed to evaluate whether an enhanced early addiction care pathway improves retention in addiction treatment among patients admitted to the emergency department for acute intoxication involving at least one illicit psychoactive substance (excluding isolated alcohol intoxication).
All participants will receive an early addiction consultation within 24 to 72 hours of the acute event. In the experimental group, this consultation will be combined with a structured, standardized feedback session regarding toxicology results and a proactive follow-up strategy involving scheduled telephone contacts over a 6-month period. The control group will receive an early addiction consultation according to standard care procedures, without the structured feedback and standardized follow-up program implemented in the experimental group.
The primary objective of the study is to determine whether the enhanced intervention improves retention in the addiction care pathway 6 months after enrollment. Retention is defined as sustained engagement in addiction care, operationalized as at least one addiction-related consultation per month and/or regular telephone follow-up over the 6-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted and/or hospitalized in the emergency department or intensive care unit following acute poisoning must:
- •Be over 18 years of age
- •Have consumed at least one identifiable non-alcoholic narcotic, including psychoactive substances detected by standard urine drug screening (dipstick)
- •Have a history of using at least one non-alcoholic psychoactive substance within the last 30 days
- •Speak and understand French
- •Have at least 1 cm of hair
- •Be covered by a social security scheme (member or dependent)
- •Be the patient or a relative/close contact/trusted person who has been informed about the study and has given their informed consent (or completed the emergency inclusion procedure)
- •Have a mobile phone number or email address to be contacted
排除标准
- •Acute suicidal crisis requiring priority psychiatric care
- •Acute alcohol intoxication (after confirmation by urine drug screening in the Emergency Department)
- •Acute episode related to exclusive opiate use, requiring opiate substitution therapy
- •Prolonged hospitalization in intensive care or follow-up care due to complications of alcohol intoxication beyond 8 days after the initial addiction assessment
- •Protected patient: under a valid legal guardianship, curatorship, or conservatorship
- •Patient requiring involuntary psychiatric hospitalization
结局指标
主要结局
Retention in addiction care at 6 months
时间窗: 6 months after randomization
Proportion of randomized participants who are still actively engaged in a structured addiction care pathway 6 months after randomization. Retention is defined as attendance at ≥1 scheduled addiction care contact (in-person visit, structured psychological session, or protocol-defined telephone follow-up) within the predefined follow-up window around Month 6 (±30 days), without documented loss to follow-up or withdrawal from addiction care.
次要结局
- Rate of recurrent acute intoxication episodes.(3 months and 6 months after randomization)
- Change in Anxiety and depression score(Randomisation (Day 7) and Month 1; relapse assessed up to 6 months)
- Change in health-related quality score(Randomisation (Day 7) and Month 1; relapse assessed up to 6 months)
- Change in severity of sleep disorders score(Randomisation (Day 7) and Month 1; relapse assessed up to 6 months)
- Change in Need for thrills score(Randomisation (Day 7) and Month 1; relapse assessed up to 6 months)
- Change in drug use practices : weekly Number of Drug Use Sessions(From baseline (inclusion) to 6 months; assessed at Month 1 (M1), Month 3 (M3), Month 4 (M4), and Month 6 (M6))
- Change in drug use practices : daily quantity consumed(From baseline (inclusion) to 6 months; assessed at Month 1 (M1), Month 3 (M3), Month 4 (M4), and Month 6 (M6))
- Number of Analytical Results Transmitted to the OFDT(From baseline (Day 0) to Month 6)
- Change in the frequency and/or occurrence of drug-related complications(From baseline (inclusion) to 6 months; assessed at Month 1 (M1), Month 3 (M3), Month 4 (M4), and Month 6 (M6))
- Change in harm reduction knowledge and implementation score(Month 1 (baseline for knowledge assessment), Month 3, and Month 6)
- Number of Declarations Submitted to the Regional Health Agency (ARS)(From baseline (Day 0) to Month 6)
- Number of Addiction-Vigilance Notifications Transmitted to the French Addictovigilance Network (CEIP)(From baseline (Day 0) to Month 6)