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Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Analgesic Solutions.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562353
First Posted: March 23, 2012
Last Update Posted: September 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Analgesic Solutions
March 22, 2012
March 23, 2012
September 16, 2013
April 2012
December 2013   (Final data collection date for primary outcome measure)
mRNA Levels [ Time Frame: 1 day ]
mRNA levels for all known genes and exons
Same as current
Complete list of historical versions of study NCT01562353 on ClinicalTrials.gov Archive Site
  • FTQ [ Time Frame: 1 day ]
    Family Tree Questionnaire
  • TEQ [ Time Frame: 1 day ]
    Trauma Exposure Questionnare
  • LSQ [ Time Frame: 1 day ]
    Life Stress Questionnaire
  • POCS [ Time Frame: 1 day ]
    Prescription Opioid Craving Scale
  • POAQ [ Time Frame: 1 day ]
    Prescription Opioid Analgesic Questionnaire
  • mARCI [ Time Frame: 1 day ]
    Modified Addiction Research Center Inventory
  • MINI [ Time Frame: 1 day ]
    Mini International Neuropsychiatric Interview
Same as current
Not Provided
Not Provided
 
Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
One tube (2.5-5.0 mL) of blood will be drawn from each subject during the visit for mRNA testing
Non-Probability Sample
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.
Usage of Prescription Opioids
Not Provided
  • 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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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).
  • 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).

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01562353
CPH.CSA.0005
No
Not Provided
Not Provided
Analgesic Solutions
Analgesic Solutions
Not Provided
Principal Investigator: Nathaniel P Katz, MD, MS Analgesic Solutions
Analgesic Solutions
September 2013