PRJ2215: Assessment of Buproprion Misuse/Abuse 2004-2011
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major
Intervention: Bupropion (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: PRJ2215: Assessment of Buproprion Misuse/Abuse 2004-2011
Study design: Observational Model: Case-Only, Time Perspective: Cross-Sectional
Primary outcome: The number of bupropion abuse case reports from the DAWN data.
Detailed description:
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.
DAWN collects data on all types of drugs—illegal drugs, prescription and over-the-counter
medications, dietary supplements, and both pharmaceutical and nonpharmaceutical inhalants.
DAWN notes whether alcohol is involved in addition to drug(s) for patients of all ages.
Because alcohol is considered an illicit drug for minors, alcohol abuse without the
involvement of other drugs is considered a drug-related ED visit for patients under the age
of 21. DAWN does not report current medications (i. e., medications and pharmaceuticals taken
regularly by the patient as prescribed or indicated) that are deemed by the ED medical staff
to be unrelated to the ED visit.
The study population includes patients of all ages presenting to emergency departments for
drug-related causes. The DAWN visit eligibility criteria are intended to be broad and
inclusive and to have few exceptions. They take into account the fact that documentation in
medical records varies in clarity and completeness across hospitals and among clinicians
within hospitals. The criteria are designed to minimize the potential for DAWN Reporter
judgments that could cause data to vary systematically and unexpectedly across different
data collectors and hospitals. In addition, the criteria allow for the capture of a diverse
set of drug-related visits that can be aggregated or disaggregated to serve a variety of
analytical purposes and the interests of multiple audiences.
There are few variables within the DAWN dataset. For this analysis, variables of interest
can be grouped into the following categories: year of visit, age, sex, race, reason for
presentation to the emergency department, case type, drug, route of administration,
toxicology confirmed, and result of treatment in ED.
The Drug Abuse Warning Network datasets from 2004-2011 will be used for the proposed
analyses.
All eligible DAWN cases will be included in this analysis.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All DAWN case reports mentioning use of bupropion will be included in this analysis.
Exclusion Criteria:
- None
Locations and Contacts
Additional Information
Starting date: November 2013
Last updated: March 9, 2015
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