NCT02225184

Completed

Impact of Delta Opioid Receptor Gene (OPRD1) Variations on T...

National Institute on Drug Abuse (NIDA)Source

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Other study identifiers

Sponsor study identifier

999914167

Secondary identifiers

14-DA-N167

Study Type

observational

Actual enrollment (reported)

81

Locations

1 country

Sites

1

Timeline

Study Start

August 23, 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 31, 2018

Actual (reported)

Study Completion

December 31, 2018

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 81 participants
Study completion date: December 31, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
August 23, 2014
Actual (reported)
Study Start
August 23, 2014
Date type not reported
This date has not been verified as actual or estimated.
First Posted
August 26, 2014
Actual (reported)
Primary Completion
December 31, 2018
Actual (reported)
Study Completion
December 31, 2018
Actual (reported)

Last Updated: January 3, 2019
Status Verified: December 31, 2018
Last Update Submitted: January 1, 2019

Conditions

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

Keywords

Opioid DependenceOPRM1OutcomeTreatment

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

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (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;

Sponsors & Collaborators

National Institute on Drug Abuse (NIDA)
NIHlead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

MeSH Terms

Conditions

Substance-Related DisordersOpioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Study Officials

Karran A Phillips, M.D.
National Institute on Drug Abuse (NIDA)
PRINCIPAL INVESTIGATOR

Enrollment

81 participants (actual enrollment reported by the registry).

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

Date type not reported

This date has not been verified as actual or estimated.

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.

Contact the study team to confirm eligibility.

Primary Completion

December 31, 2018

Actual (reported)

Study Completion

December 31, 2018

Actual (reported)

Last Updated

January 3, 2019

Record last verified: 2018-12-31

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02225184
Data provider: ClinicalTrials.gov
Source updated: 2019-01-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:34 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations