PRJ2215: Assessment of Buproprion Misuse/Abuse 2004-2011
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- The number of bupropion abuse case reports from the DAWN data.
研究概览
简要总结
Bupropion hydrochloride was first approved on 30 December 1985 in United States for depression and is currently approved in 80 countries. Bupropion has also subsequently been approved for smoking cessation and for seasonal affective disorder.
Cumulative exposure to bupropion is estimated at approximately 97.3 million patient exposures up to 31 December 2012.
Bupropion hydrochloride is a weak catecholamine reuptake inhibitor predominantly affecting serotonin, norepinephrine and dopamine. Its mechanism of action and its structural similarities to diethylpropion, amphetamines, and cocaine, bupropion resembles stimulants in many respects, leading to concerns about potential abuse of the product.
Abuse potential had been part of the Benefit Risk Management Plan for bupropion up until 2003 and at that point, had no longer been regarded as a potential risk that required additional/further evaluation outside standard pharmacovigilance monitoring. The current European Risk Management Plan also states that standard pharmacovigilance monitoring applies to abuse potential. Monitoring has shown a recent increase in the number of spontaneous reports from the Adverse Event reporting System (AERS) of drug abuse.
The bupropion team agreed that although the numbers of abuse reports was small relative to the total number of reports for bupropion in OCEANS, there was sufficient information in AERS to warrant investigation of the potential effect on public health.
To investigate the degree of misuse and abuse of bupropion (including non-oral routes of administration) in the United States, the Drug Abuse Warning Network will be used to examine the study period 2004-2011.
详细描述
There are two primary objectives to the study, which are as follows: 1) to examine the number of bupropion reports over time within the DAWN database and to describe the number of all DAWN reports for prescription drugs and 2) to examine the number of reports for bupropion, stratified by demographics, route of administration, and disposition of the patient.
If sample size permits, an evaluation of the disposition of the patients exposed to only bupropion at the time of Emergency Department (ED) visit will be conducted.
DAWN is a public health surveillance system that reports on drug-related visits to hospital Emergency Departments (ED). DAWN is used to monitor trends in drug misuse and abuse, identify the emergence of new substances and drug combinations, assess health hazards associated with drug use and abuse, and estimate the impact of drug use, misuse, and abuse on the United States' health care system.
DAWN's target sample frame consists of all non-Federal, short-stay, general medical and surgical hospitals in the United States that have one or more EDs open 24 hours a day. DAWN employs a multistage sampling design for the selection of EDs for analysis. Stratified simple random sampling with oversampling in selected metropolitan areas is used to select the hospitals.
A DAWN case is any ED visit involving recent drug use. DAWN cases are identified through the review of ED medical records in participating hospitals. DAWN captures both ED visits that are directly caused by drugs and those in which drugs are a contributing factor but not the direct cause of the ED visit. These criteria encompass all types of drug-related events, including accidental ingestion and adverse reaction, as well as drug misuse or abuse.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All DAWN case reports mentioning use of bupropion will be included in this analysis.
排除标准
- 未提供
研究组 & 干预措施
DAWN cases including all prescription drugs
This group will consist of all DAWN cases where prescription drugs are mentioned.
干预措施: Bupropion (Drug)
All bupropion cases (including use of other drugs)
This group will consist of all DAWN cases where bupropion is mentioned and is a subset of Group 1.
干预措施: Bupropion (Drug)
Burpropion Only Cases
This group will consist of all DAWN cases where burpropion is specifically the only drug mentioned within the case report, and is a subset of Group 2.
干预措施: Bupropion (Drug)
结局指标
主要结局
The number of bupropion abuse case reports from the DAWN data.
时间窗: Up to 8 years
Abuse case reports of interest include unlicensed route of administration, specifically, inhalation of bupropion.
次要结局
未报告次要终点