Opioid Abuse or DependenceNCT01881802
Study of Opioid Immunosuppressive Effects
An observational study of Opioid Abuse or Dependence, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Opioid Abuse or Dependence
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Guangzhou Psychiatric Hospital
Who may be able to join
- 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
- if they were abusing substances other than heroin (as determined by urine drug test result). For women, pregnancy was also a reason for exclusion.
Who cannot join
- Control subjects with no history of drug or alcohol abuse were also excluded if they had
- major medical or psychiatric disorders
About this study
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.
- Conditions
- Opioid Abuse or Dependence
- Keywords
- Opioid drug Abuse, Morphine, Immune Function
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| morphine or heroin dependence patients | Not described | |
| normal control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
real-time quantitative polymerase chain reaction
Measured: up to 2 months
Secondary outcomes (1)
enzyme-linked immuno sorbent assay
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Abuse or DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohong Long, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881802
- Sponsor's protocol ID
- 01
- Status last verified
- Jun 2013
- First submitted
- 3 Jun 2013
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Opioid Immunosuppressive Effects
- ClinicalTrials.gov ID
- NCT01881802
- Acronym / sponsor ID
- 01
- Conditions
- Opioid Abuse or Dependence
- Keywords
- Opioid drug Abuse, Morphine, Immune Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (estimated)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morphine or heroin dependence patients | – | – |
| normal control group | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Guangzhou Psychiatric Hospital
Key inclusion criteria (3 listed)
- 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
- if they were abusing substances other than heroin (as determined by urine drug test result). For women, pregnancy was also a reason for exclusion.
Key exclusion criteria (2 listed)
- Control subjects with no history of drug or alcohol abuse were also excluded if they had
- major medical or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
real-time quantitative polymerase chain reaction
Time frame: up to 2 months
1 secondary outcome
enzyme-linked immuno sorbent assay
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Abuse or Dependence, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
real-time quantitative polymerase chain reaction (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.