Usage of Prescription OpioidsNCT01562353
Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction
An observational study of Usage of Prescription Opioids, run by Analgesic Solutions at 1 site in United States.
Trial summary
This is a clinical study on patients who have been prescribed opioids (narcotic pain relievers) for the treatment of pain, to determine what genetic factors influence outcome of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Usage of Prescription Opioids
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A sample of 15 subjects per group will be sought. Cases and Controls will be selected by a community-based advertising program supplemented by referrals from clinicians.
Who may be able to join
- Subject is 18 years or older.
- Subject is willing and able to speak, read, and write in English and comply with all study procedures.
- Subject is willing and able to voluntarily sign and date an Informed Consent Form (ICF), approved by an Institutional Review Board (IRB), prior to the conduct of any study-specific procedures.
- Subject has been prescribed opioids for the treatment of pain for at least 6 months at the time of the study.
- Cases:
- Subject has a diagnosis of current prescription opioid dependence (confirmed by the MINI).
Show all 11Show fewer
- Subject had no history of dependence on alcohol or illicit or prescription drugs, including opioids, prior to prescription opioid exposure for the treatment of chronic pain. Patients who have abused these substances but have not met criteria for dependence (confirmed by the MINI and/or medical history) will be included.
- Controls:
- Subject's prescribing physician has reported absence of significant problematic behavior with respect to prescription opioids or other substances while under the physician's care.
- Subject has a negative urine drug screen for alcohol, illicit drugs, and nonprescribed controlled substances at screening.
- Subject has no current or past substance abuse or dependence (confirmed by the MINI and medical history).
Who cannot join
- Subject has any condition that poses undo study-related risk, or that interferes with assessment.
- Subject is not willing to have blood drawn or has any condition that in the investigators' opinion precludes having blood drawn.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Analgesic Solutions
Natick, Massachusetts, 01760
Kcennia Sacramed, BSc, 781-444-9605 ext. 127, ksacramed@analgesicsolutions.com
Nathaniel P Katz, MD, MS
About this study
Official title: A Pilot Study to Determine the Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction in Patients Treated for Pain Using a Comparative Transcriptomic Analysis of Gene Expression in Peripheral Blood Cells
This is a clinical study on patients who have been prescribed opioids (narcotic pain relievers) for the treatment of pain, to determine what genetic factors influence outcome of treatment. Procedures include: an initial telephone prescreening, completion of a number of questionnaires, and a blood draw to determine genetic factors. Participants will take part in a one-time clinic visit, during which all procedures will be completed.
The investigators hypothesize that several classes of genes, including genes in opioid, pain, and reward pathways, will differentiate opioid-dependent subjects from opioid-exposed nondependent subjects.
- Conditions
- Usage of Prescription Opioids
- Keywords
- Opioid Dependence, Opioids for the treatment of pain
- 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 |
|---|---|---|
| Case | Subject has a diagnosis of current prescription opioid dependence (confirmed by the MINI). Subject had no history of dependence on alcohol or illicit or prescription drugs, including opioids, prior to prescription opioid exposure for the treatment of chronic pain. | |
| Control | Subject's prescribing physician has reported absence of significant problematic behavior with respect to prescription opioids or other substances while under the physician's care. Subject has a negative urine drug screen for alcohol, illicit drugs, and nonprescribed controlled substances at screening. Subject has no current or past substance abuse or dependence (confirmed by the MINI and medical history). |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA Levels
mRNA levels for all known genes and exons
Measured: 1 day
Secondary outcomes (7)
FTQ
Family Tree Questionnaire
Measured: 1 day
TEQ
Trauma Exposure Questionnare
Measured: 1 day
LSQ
Life Stress Questionnaire
Measured: 1 day
POCS
Prescription Opioid Craving Scale
Measured: 1 day
POAQ
Prescription Opioid Analgesic Questionnaire
Measured: 1 day
mARCI
Modified Addiction Research Center Inventory
Measured: 1 day
MINI
Mini International Neuropsychiatric Interview
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Usage of Prescription OpioidsStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Analgesic Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathaniel P Katz, MD, MS, Principal investigator, Analgesic Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562353
- Sponsor's protocol ID
- CPH.CSA.0005
- Status last verified
- Sep 2013
- First submitted
- 22 Mar 2012
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction in Patients Treated for Pain Using a Comparative Transcriptomic Analysis of Gene Expression in Peripheral Blood Cells
- ClinicalTrials.gov ID
- NCT01562353
- Acronym / sponsor ID
- CPH.CSA.0005
- Conditions
- Usage of Prescription Opioids
- Keywords
- Opioid Dependence, Opioids for the treatment of pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Analgesic SolutionsIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Mar 2012 (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 is a clinical study on patients who have been prescribed opioids (narcotic pain relievers) for the treatment of pain, to determine what genetic factors influence outcome of treatment. Procedures include: an initial telephone prescreening, completion of a number of questionnaires, and a blood draw to determine genetic factors. Participants will take part in a one-time clinic visit, during which all procedures will be completed.
The investigators hypothesize that several classes of genes, including genes in opioid, pain, and reward pathways, will differentiate opioid-dependent subjects from opioid-exposed nondependent subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Subject has a diagnosis of current prescription opioid dependence (confirmed by the MINI). Subject had no history of dependence on alcohol or illicit or prescription drugs, including opioids, prior to prescription opioid exposure for the treatment of chronic pain. |
| Control | – | –Subject's prescribing physician has reported absence of significant problematic behavior with respect to prescription opioids or other substances while under the physician's care. Subject has a negative urine drug screen for alcohol, illicit drugs, and nonprescribed controlled substances at screening. Subject has no current or past substance abuse or dependence (confirmed by the MINI and medical history). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A sample of 15 subjects per group will be sought. Cases and Controls will be selected by a community-based advertising program supplemented by referrals from clinicians.
Key inclusion criteria (11 listed)
- Subject is 18 years or older.
- Subject is willing and able to speak, read, and write in English and comply with all study procedures.
- Subject is willing and able to voluntarily sign and date an Informed Consent Form (ICF), approved by an Institutional Review Board (IRB), prior to the conduct of any study-specific procedures.
- Subject has been prescribed opioids for the treatment of pain for at least 6 months at the time of the study.
- Subject has a diagnosis of current prescription opioid dependence (confirmed by the MINI).
Key exclusion criteria (2 listed)
- Subject has any condition that poses undo study-related risk, or that interferes with assessment.
- Subject is not willing to have blood drawn or has any condition that in the investigators' opinion precludes having blood drawn.
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
mRNA Levels
Time frame: 1 day
mRNA levels for all known genes and exons
7 secondary outcomes
FTQ
Time frame: 1 day
TEQ
Time frame: 1 day
LSQ
Time frame: 1 day
POCS
Time frame: 1 day
POAQ
Time frame: 1 day
mARCI
Time frame: 1 day
MINI
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
Related trials for Usage of Prescription Opioids
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Recruiting
MATAspire: Mental Health Awareness Tailored App for Substance Prevention and Integrated Resilience Education
Alcohol Use, Cannabis Use
Recruiting
The ENHANCE Project Toolkit
Substance Related Disorder, Drug Overdose
Not yet recruiting
The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study
Opioid Use Disorder, Overdose, Drug
Active, not recruiting
Supporting Treatment Access and Recovery Through Linkage and Support
Mental Health Disorders, Substance Use Disorders
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.
Nathaniel P Katz, MD, MS principal investigator
Analgesic Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Usage of Prescription Opioids, run by Analgesic Solutions at 1 site in United States.
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 11 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 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Kcennia Sacramed, BSc (781-444-9605 ext. 127, ksacramed@analgesicsolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRNA Levels (time frame: 1 day). 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 16 Sep 2013.