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Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction

This study is not yet open for participant recruitment.
Verified March 2012 by Analgesic Solutions
Sponsor:
Information provided by (Responsible Party):
Analgesic Solutions
ClinicalTrials.gov Identifier:
NCT01562353
First received: March 22, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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
Usage of Prescription Opioids

Study Type: Observational
Study Design: 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

Further study details as provided by Analgesic Solutions:

Primary Outcome Measures:
  • mRNA Levels [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    mRNA levels for all known genes and exons


Secondary Outcome Measures:
  • FTQ [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Family Tree Questionnaire

  • TEQ [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Trauma Exposure Questionnare

  • LSQ [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Life Stress Questionnaire

  • POCS [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Prescription Opioid Craving Scale

  • POAQ [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Prescription Opioid Analgesic Questionnaire

  • mARCI [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Modified Addiction Research Center Inventory

  • MINI [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562353

Contacts
Contact: Pura Requintina, PhD 781-444-9605 ext 121 prequintina@analgesicsolutions.com

Locations
United States, Massachusetts
Analgesic Solutions Not yet recruiting
Natick, Massachusetts, United States, 01760
Principal Investigator: Nathaniel P Katz, MD, MS            
Sub-Investigator: Stephen L Wright, MD            
Sub-Investigator: Jeremiah J Trudeau, PhD            
Sub-Investigator: Kelly Wawrzyniak, PsyD            
Sub-Investigator: Stephen J Glatt, PhD            
Sponsors and Collaborators
Analgesic Solutions
Investigators
Principal Investigator: Nathaniel P Katz, MD, MS Analgesic Solutions
  More Information

No publications provided

Responsible Party: Analgesic Solutions
ClinicalTrials.gov Identifier: NCT01562353     History of Changes
Other Study ID Numbers: CPH.CSA.0005
Study First Received: March 22, 2012
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Analgesic Solutions:
Opioid Dependence
Opioids for the treatment of pain

Additional relevant MeSH terms:
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on June 17, 2013