NCT01881802

Brief Summary

This trial aims to investigate the effects of opioid-inducing immune suppression on opioid drug abused patients. The methods of the investigators research mainly includes the expression of morphine-related miRNAs in peripheral blood mononuclear cells and cytokine in plasma.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

3 months

First QC Date

June 3, 2013

Last Update Submit

June 19, 2013

Conditions

Opioid Abuse or Dependence

Keywords

Opioid drug AbuseMorphineImmune Function

Outcome Measures

Primary Outcomes (1)

  • real-time quantitative polymerase chain reaction

    up to 2 months

Secondary Outcomes (1)

  • enzyme-linked immuno sorbent assay

    up to 2 months

Study Arms (2)

morphine or heroin dependence patients

normal control group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Guangzhou Psychiatric Hospital

You may qualify if:

  • subjects were excluded if they had a chronic systemic illness (cardiac, renal, pulmonary, hepatic, endocrine, metabolic, or autoimmune disorders) or
  • a major psychiatric disorder or

You may not qualify if:

  • Control subjects with no history of drug or alcohol abuse were also excluded if they had
  • major medical or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

The refrigerator - 80 degrees

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctoral candidate

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 20, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Last Updated

June 20, 2013

Record last verified: 2013-06