Drug Abuse During the COVID-19 Pandemic. | NCT04811352

Studies
Drug Abuse During the COVID-19 Pandemic.

NCT04811352

Sponsor

Instituto Mexicano del Seguro Social

Status

Completed

Last Update Posted

Oct 2, 2023Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Substance Abuse
Stress, Psychological

Interventions

Not provided

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

May 1, 2021Actual

Completion Date

Jun 1, 2021Actual

First Submitted Date

Mar 22, 2021

First Submission Date that Met QC Criteria

Mar 22, 2021

First Posted Date

Mar 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2023

Last Update Posted Date

Oct 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

GONZALEZ-OJEDA ALEJANDRO, Principal Investigator, Instituto Mexicano del Seguro SocialPrincipal Investigator

Lead Sponsor

Instituto Mexicano del Seguro SocialOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The pandemic we live through has put various sectors of the medical system and its tributaries to the test. The accumulation of external and internal stress has been completely correlated with the predisposition to psycho-emotional problems and, in turn, to drug use as an immature response for ego protection. That is why the economic, social, and psychological evaluation can help understand the current situation about drug abuse and how to help patients afflicted by it. The added stress of personal problems, work alterations, daily life in a pandemic, economic and varied responsibilities, and the understanding of the pandemic have predisposed and amplified the use of drugs to reduce emotional distress perceived by individuals. The hypothesis of this study is that the increment of stress and a lack of preparation for the pandemic are associated with increased drug abuse.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Behaviour on drug and substance abuse	The survey inquires about the frequency and dosage of numerous substances such as coffee, alcohol, tobacco, and heroin since the pandemic started.	Baseline
PHQ-9 Score	This inventory will be used to identify the presence and intensity of depressive disorders. The minimum score is 0, and the maximum score is 27.	Baseline
GAD-7 Score	This questionnaire will be used to evaluate the presence and intensity of anxiety disorders. The minimum score is 0, and the maximum score is 21.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years old
Willing to participate in the study
Patient currently with a paying job

Exclusion Criteria:

Patients without a paying job

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult Mexican general population during the COVID-19 pandemic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Médico Nacional de Occidente		Guadalajara	Jalisco		Mexico

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders
D013315	Stress, Psychological
D000086382	COVID-19

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided