Depressive Disorder, Major Clinical Trial
Official title:
PRJ2215: Assessment of Buproprion Misuse/Abuse 2004-2011
Verified date | August 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: No Health Authority |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All DAWN case reports mentioning use of bupropion will be included in this analysis. Exclusion Criteria: |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of bupropion abuse case reports from the DAWN data. | Abuse case reports of interest include unlicensed route of administration, specifically, inhalation of bupropion. | Up to 8 years | Yes |
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