Impact of Delta Opioid Receptor Gene (OPRD1) Variations on Treatment Outcome in African Americans

NCT02225184 | Completed

• 2 other identifiers: 99991416714-DA-N167
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Differences in peoples genes can make them respond to drugs in different ways. Methadone and buprenorphine are two drugs used to treat drug addiction. A study showed that African Americans with a certain genetic marker did better using one kind of drug treatment over the other. Researchers want to see if they can repeat these findings. They also want to study other things that affect how well people do in treatment. Objective: \- To see if certain genetic markers and other facts about a person s life can predict how well they do in treatment for addiction to opioids and cocaine. Eligibility: \- African American adults age 18 and over. They must be former or current participants in an Archway Treatment Clinic study. They must have been on a stable dose of either study drug for at least 12 weeks. They also must have given urine samples regularly for at least 10 weeks. Design:

• Participants will come to the clinic for 1 visit lasting about 2 hours.
• Participants will give 1 teaspoon of blood for genetic testing. They will be asked if their sample can be used in future studies.
• If researchers cannot get enough blood, they will do a cheek swab. This will collect skin cells for genetic testing.
• Participants will fill out 3 questionnaires.
• Results of genetic testing and answers to questionnaires will be kept private.

Conditions

Genetic Underpinning of Substance Abuse; Polymorphism-genetic; Drug Abuse/Dependence; Opiod-Related Disorders

Keywords

Opioid Dependence; OPRM1; Outcome; Treatment

Outcome Measures

Primary Outcomes (1)

• To independently replicate the pharmacogenetic findings of the NIDA CTN START substudy by comparing urine opioid results as a function of rs678849 genotype among opioid-addicted African-Americans treated with either buprenorphine or methadone.

  9/2014 to 5/2016

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current or former participation in an Archway methadone or buprenorphine treatment study;
• Age 18 or older;
• Meet DSM-IV criteria for opioid dependence;
• Self-identified as African American, with at least 3 African American grandparents by self-report;
• At least 12 weeks of continuous treatment with a stable dose (no taper \>7 days in length) of either buprenorphine or methadone, in a treatment regimen in which the physician considers dose increases in response to withdrawal symptoms, craving, or evidence of illicit opioid use by urine screens;
• At least 10 weeks of urine results available for analysis in that 12-week period, with no more than 6 consecutive urine data points missing, a requirement that should limit non-compliance as a factor;
• Able to speak and read English sufficiently to provide informed consent;
• Former participants only: have consented to future contact .

You may not qualify if:

• (1) Inability to give informed consent.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• Karran A Phillips, M.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2014
• First Posted: August 26, 2014
• Study Start: August 23, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 3, 2019

Record last verified: 2018-12-31

Locations

US (1)