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Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction

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ClinicalTrials.gov Identifier: NCT01562353
Recruitment Status : Unknown
Verified September 2013 by Analgesic Solutions.
Recruitment status was:  Recruiting
First Posted : March 23, 2012
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Analgesic Solutions

Study Description
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Brief 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. 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.


Condition or disease
Usage of Prescription Opioids

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Retrospective
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
Study Start Date : April 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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).


Outcome Measures
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Primary Outcome Measures :
  1. mRNA Levels [ Time Frame: 1 day ]
    mRNA levels for all known genes and exons


Secondary Outcome Measures :
  1. FTQ [ Time Frame: 1 day ]
    Family Tree Questionnaire

  2. TEQ [ Time Frame: 1 day ]
    Trauma Exposure Questionnare

  3. LSQ [ Time Frame: 1 day ]
    Life Stress Questionnaire

  4. POCS [ Time Frame: 1 day ]
    Prescription Opioid Craving Scale

  5. POAQ [ Time Frame: 1 day ]
    Prescription Opioid Analgesic Questionnaire

  6. mARCI [ Time Frame: 1 day ]
    Modified Addiction Research Center Inventory

  7. MINI [ Time Frame: 1 day ]
    Mini International Neuropsychiatric Interview


Biospecimen Retention:   Samples With DNA
One tube (2.5-5.0 mL) of blood will be drawn from each subject during the visit for mRNA testing

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562353


Contacts
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Contact: Kcennia Sacramed, BSc 781-444-9605 ext 127 ksacramed@analgesicsolutions.com
Contact: Stephen L Wright, MD 781-444-9605 ext 101 swright@analgesicsolutions.com

Locations
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United States, Massachusetts
Analgesic Solutions Recruiting
Natick, Massachusetts, United States, 01760
Contact: Kcennia Sacramed, BSc    781-444-9605 ext 127    ksacramed@analgesicsolutions.com   
Principal Investigator: Nathaniel P Katz, MD, MS         
Sub-Investigator: Stephen L Wright, MD         
Sub-Investigator: Stephen J Glatt, PhD         
Sub-Investigator: Alice Brown, MD         
Sponsors and Collaborators
Analgesic Solutions
Investigators
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Principal Investigator: Nathaniel P Katz, MD, MS Analgesic Solutions
More Information
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Responsible Party: Analgesic Solutions
ClinicalTrials.gov Identifier: NCT01562353     History of Changes
Other Study ID Numbers: CPH.CSA.0005
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013
Keywords provided by Analgesic Solutions:
Opioid Dependence
Opioids for the treatment of pain
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents