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.

Study Overview

• Status: Unknown
• Conditions: Usage of Prescription Opioids

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Kcennia Sacramed, BSc; Phone Number: 127 781-444-9605; Email: ksacramed@analgesicsolutions.com
• Study Contact Backup: Name: Stephen L Wright, MD; Phone Number: 101 781-444-9605; Email: swright@analgesicsolutions.com

Study Locations

• United States
  • Massachusetts
    • Natick, Massachusetts, United States, 01760
      • Recruiting
      • Analgesic Solutions
      • Contact: Kcennia Sacramed, BSc; Phone Number: 127 781-444-9605; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRNA Levels	mRNA levels for all known genes and exons	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FTQ	Family Tree Questionnaire	1 day
TEQ	Trauma Exposure Questionnare	1 day
LSQ	Life Stress Questionnaire	1 day
POCS	Prescription Opioid Craving Scale	1 day
POAQ	Prescription Opioid Analgesic Questionnaire	1 day
mARCI	Modified Addiction Research Center Inventory	1 day
MINI	Mini International Neuropsychiatric Interview	1 day

Collaborators and Investigators

• Sponsor: Analgesic Solutions
• Investigators: Principal Investigator: Nathaniel P Katz, MD, MS, Analgesic Solutions

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Estimate): September 16, 2013
• Last Update Submitted That Met QC Criteria: September 13, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Opioid Dependence; Opioids for the treatment of pain
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: CPH.CSA.0005