Genetic Underpinning of Substance AbuseNCT02225184
Impact of Delta Opioid Receptor Gene (OPRD1) Variations on Treatment Outcome in African Americans
An observational study of Genetic Underpinning of Substance Abuse and Polymorphism-genetic, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genetic Underpinning of Substance Abuse, Polymorphism-genetic, Drug Abuse/Dependence
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2014to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Official title: The Impact of Delta Opioid Receptor Gene (OPRD1) Variations on Treatment Outcome in African Americans
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.
Read more
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.
Read the 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 = 0.53, 95% CI 0.46-0.60, p = 0.001). 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 = 2.13, 95% CI 1.81-2.45, p = 0.012). 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 n=135 (to obtain 130 completers; 65 methadone, 65 buprenorphine) current and former participants in Archway treatment studies in order to have power of 0.80 to detect a difference of 0.5 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.
- Conditions
- Genetic Underpinning of Substance Abuse, Polymorphism-genetic, Drug Abuse/Dependence, Opiod-Related Disorders
- Keywords
- Opioid Dependence, OPRM1, Outcome, Treatment
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9/2014 to 5/2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start23 Aug 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic Underpinning of Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Karran A Phillips, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225184
- Sponsor's protocol ID
- 999914167
- Other IDs
- 14-DA-N167
- Status last verified
- 31 Dec 2018
- First submitted
- 23 Aug 2014
- Last updated
- 3 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Delta Opioid Receptor Gene (OPRD1) Variations on Treatment Outcome in African Americans
- ClinicalTrials.gov ID
- NCT02225184
- Acronym / sponsor ID
- 999914167
- Conditions
- Genetic Underpinning of Substance Abuse, Polymorphism-genetic, Drug Abuse/Dependence, Opiod-Related Disorders
- Keywords
- Opioid Dependence, OPRM1, Outcome, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 23 Aug 2014
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 = 0.53, 95% CI 0.46-0.60, p = 0.001). 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 = 2.13, 95% CI 1.81-2.45, p = 0.012). 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 n=135 (to obtain 130 completers; 65 methadone, 65 buprenorphine) current and former participants in Archway treatment studies in order to have power of 0.80 to detect a difference of 0.5 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 design
- Observational model
- Ecologic or community
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (1 listed)
- Inability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 9/2014 to 5/2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karran A Phillips, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Underpinning of Substance Abuse and Polymorphism-genetic, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 9/2014 to 5/2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.