PRJ2215: Assessment of Buproprion Misuse/Abuse 2004-2011

NCT02039960 | Completed

• 2 other identifiers: 201235PRJ2215
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depressive Disorder, Major

Keywords

Epidemiology; Drug Abuse Warning Network (DAWN); bupropion; abuse

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

DAWN cases including all prescription drugs

This group will consist of all DAWN cases where prescription drugs are mentioned.

Drug: Bupropion

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.

Drug: Bupropion

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.

Drug: Bupropion

Interventions

Bupropion DRUG

Bupropion is a weak catecholamine reuptake inhibitor predominantly affecting serotonin, norepinephrine and dopamine and is approved for depression, smoking cessation and seasonal affective disorder.

All bupropion cases (including use of other drugs); Burpropion Only Cases; DAWN cases including all prescription drugs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 that are deemed to be unrelated to the ED visit.

You may qualify if:

• All DAWN case reports mentioning use of bupropion will be included in this analysis.

You may not qualify if:

• None

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 20, 2014
• Study Start: November 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 5, 2016

Record last verified: 2016-08