Ignite Creation Date:
2024-05-06 @ 3:11 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02225184
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2014-08-23
Brief Title:
Impact of Delta Opioid Receptor Gene OPRD1 Variations on Treatment Outcome in African Americans
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Impact of Delta Opioid Receptor Gene OPRD1 Variations on Treatment Outcome in African Americans
Status:
COMPLETED
Status Verified Date:
2018-12-31
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
- 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
Detailed Description:
The NIDA Clinical Trials Network s CTN START Study was designed to look at the pharmacogenetics of treatment response The CTN investigators found that an intronic SNP rs678849 in the gene for the opioid delta-1 receptor OPRD1 strongly predicted treatment response in African-Americans Specifically during treatment with methadone African-Americans with one variant of the SNP CC were less likely to use illicit opioids compared to African-Americans with other variants of the SNP CT or TT relative risk 053 95 CI 046-060 p 0001 During treatment with buprenorphine the association was reversed African-Americans with the CC variant were more likely to use illicit opioids compared to those with the CT or TT variants relative risk 213 95 CI 181-245 p 0012 This pattern of findings was unexpected both in terms of racial specificity and differential drug associations Replication in a new sample is crucial to determining whether it represents a real effect
Study objectives include 1 To independently replicate the pharmacogenetic NIDA CTN findings by comparing urine drug screen opioid results for rs678849 genotype groups among opioid-addicted African-American individuals treated with either buprenorphine or methadone 2 To determine whether any effect of rs678849 genotype varies by demographic drug use mental health and psychosocial characteristics 3 To determine whether any effect of rs678849 genotype extends to cocaine use and 4 To examine haplotype blocks in OPRD1 that might help explain the association
We will recruit a sample of n135 to obtain 130 completers 65 methadone 65 buprenorphine current and former participants in Archway treatment studies in order to have power of 080 to detect a difference of 05 standard deviations between rs678849 genotypes To be eligible participants must have received a stable dose no taper 7 days in length of buprenorphine or methadone for at least 12 weeks and had at least 10 weekly urine drug screens during that time After informed consent in an approximate 3-hour session participants will undergo collection of blood or a buccal swab for DNA extraction and analysis blood is preferred but buccal extraction enables inclusion of participants with poor venous access and will complete 3 questionnaires the Addiction Severity Index the Perceived Neighborhood Scale and sections of the Diagnostic Instrument for Genetic Studies
Study objectives include 1 To independently replicate the pharmacogenetic NIDA CTN findings by comparing urine drug screen opioid results for rs678849 genotype groups among opioid-addicted African-American individuals treated with either buprenorphine or methadone 2 To determine whether any effect of rs678849 genotype varies by demographic drug use mental health and psychosocial characteristics 3 To determine whether any effect of rs678849 genotype extends to cocaine use and 4 To examine haplotype blocks in OPRD1 that might help explain the association
We will recruit a sample of n135 to obtain 130 completers 65 methadone 65 buprenorphine current and former participants in Archway treatment studies in order to have power of 080 to detect a difference of 05 standard deviations between rs678849 genotypes To be eligible participants must have received a stable dose no taper 7 days in length of buprenorphine or methadone for at least 12 weeks and had at least 10 weekly urine drug screens during that time After informed consent in an approximate 3-hour session participants will undergo collection of blood or a buccal swab for DNA extraction and analysis blood is preferred but buccal extraction enables inclusion of participants with poor venous access and will complete 3 questionnaires the Addiction Severity Index the Perceived Neighborhood Scale and sections of the Diagnostic Instrument for Genetic Studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14-DA-N167 | None | None | None |