Recruiting

Genetic Biomarkers

Sponsor:

Analgesic Solutions

Code:

NCT01562353

Conditions

Usage of Prescription Opioids

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Usage of Prescription Opioids

Study ID

NCT01562353

Start date

Apr, 2012

Status verified date

Sep, 2013

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Primary outcome measure

  • mRNA Levels [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Kcennia Sacramed, BSc

781-444-9605ksacramed@analgesicsolutions.com

Stephen L Wright, MD

781-444-9605swright@analgesicsolutions.com

Locations

Analgesic Solutions

Recruiting

Natick, Massachusetts, United States, 01760

Contacts

Kcennia Sacramed, BSc

781-444-9605ksacramed@analgesicsolutions.com

Principal Investigator:

Nathaniel P Katz, MD, MS

More Information

Sponsor

Analgesic Solutions

Last update posted

Sep 16, 2013

Last verified

Sep, 2013

Keywords

  • Opioid Dependence
  • Opioids for the treatment of pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Analgesic Solutions on 2013-09-16.