Feasibility of Conducting Genetics Research at Community Treatment Programs
1
Feasibility of Conducting Genetics Research at Community Treatment Programs Sonne SC 1 , Gentilin, SM 1 , Sampson R 1 , DeVane, CL 1 , Thomas, C 2 ,, Berrettini, W 3 1 Medical University of South Carolina, 2 University of California, Los Angeles, 3 University of Pennsylvania School of Medicine ABSTRACT: The addition of genetics research to pharmacotherapy trials is becoming more and more common. However, there has been some concern among community treatment providers that genetics research would be unacceptable to their clients. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting an add-on genetics substudy to a pharmacotherapy trial comparing the effects of long-term methadone and buprenorphine on liver function (Starting Treatment with Agonist Replacement Therapies, or START). The genetics substudy is exploratory in nature, with three main goals: 1) To better understand the potential genetic influence on opioid addiction (wk 2 sample); 2) To better understand how opioid dependent individuals metabolize buprenorphine and methadone (wk 12 sample); and 3) To evaluate feasibility of conducting a genetics sub-study within the CTN. Although data are still being collected to accomplish the first two goals, there is good evidence to support the feasibility of collecting genetic samples for analysis through the CTN. To date, all 8 of the START research sites have submitted samples for this substudy. Of the START participants eligible to enroll in the genetics substudy to date, 892 have been approached to participate and 846 consented. There have been 815 blood samples obtained for the week 2 sample, which goes to the NIDA repository, and 644 samples obtained and sent (at week 12) to MUSC for pharmacogenetic analysis. The genetics substudy has 4 different levels of consent so that participants can choose how their samples may be used in the future. Most participants (79%) have agreed to the most liberal use of their samples. Taken together, these data suggest that individuals in community treatment settings are willing to participate in genetic studies on addiction. INTRODUCTION METHODS RESULTS RESULTS (Continued) CONCLUSIONS / DISCUSSION Although the study of genetics can be successfully carried out within academic centers, the feasibility of implementing such a study within community treatment settings was unclear. The Clinical Trials Network (CTN) has implemented an ancillary study of genetics in conjunction with another ongoing CTN trial, Starting Treatment with Agonist Replacement Therapies, or START. Areas of interest were the ability to acquire necessary regulatory approvals across participating sites, the additional burden to research staff to execute the substudy, and the receptiveness of potential study participants to donate their genetic material for research purposes. In addition to determining the feasibility of conducting a genetics substudy within the CTN, other aims of this project were to 1) obtain genetic samples to better understand the potential genetic influence on opioid addiction (wk 2 sample); and 2) to better understand how opioid dependent individuals metabolize buprenorphine and methadone (wk 12 sample). These samples were obtained during regularly scheduled START blood draws: START study week 2: Participants provided three 7 ml tubes of blood that are sent to the Rutgers University Cell and DNA Repository for later analysis of the genetic influence on opioid addiction. START study week 12: Participants provided one 7ml tube of blood and a urine sample to the Medical University of South Carolina’s Drug Disposition Laboratory to evaluate the pharmacogenetics of buprenorphine and methadone in opioid dependent individuals. Subjects • All participants currently enrolled in the START study are eligible to participate in the genetics sub-study. Regulatory • All 8 of the sites participating in the START study obtained IRB approval of the genetic substudy from their respective IRBs. • Informed consent forms were separate documents from the START study. • Participants received on average $25 compensation for each of the two visits when genetics samples were collected. Amount of remuneration varied slightly by site. Support • A 42 page Operations Manual was developed in addition to the protocol to provide specific detail to the sites regarding study procedures. • Web based group trainings were initially held prior to study initiation and individual training was conducted via conference call for new staff as needed • A member of the genetics team attends regularly scheduled Table 2 describes the level of consent chosen by the 804 participants who supplied at least a valid week 2 sample. Of note, level 3 was the highest level of consent approved by the IRB for 2 sites. These 2 sites represented 142 (69.2%) of the 205 who consented at this level. Site # Invited # Refused % Consented # Week 2 Samples Collected # Week 12 Samples Collected Site A Site B Site C Site D Site E Site F Site G Site H All Sites 105 148 139 77 48 155 130 90 892 12 9 0 7 0 12 2 4 46 (5%) 89% 94% 100% 91% 100% 92% 98% 96% 95% 92 135 136 67 47 135 123 80 815 71 108 122 48 35 106 99 55 644 Table 1. Genetics Recruitment by Site • These data suggest that individuals seeking treatment for substance abuse in community treatment settings are willing to participate in a genetics study. • Most participants willingly consent to the most liberal use of their genetic material including storage of samples indefinitely for future use. • Although this study is ongoing, progress to date suggests it is feasible to conduct a genetics study through the NIDA Clinical Trials Network. • Site staff received significant training and support from the START lead team in conjunction with the genetics researchers, which has aided in the successful conduct of this trial. • Acceptability of genetic testing by community treatment program staff as well as research staff may play an important role in the level of consent given by research participants. Sponsored by the National Drug Abuse Treatment Clinical Trials Network As can be seen in Table 1, the majority of START participants invited to be in the genetics substudy agreed and signed informed consent. The decrease in the number of samples collected between Week 2 and Week 12 was largely due to attrition of participants from the START study. Study participants who drop out of START are no longer eligible to continue in the genetics study. Consent Levels # Participants (%) Level 1 START genetics study only 71 (8.8%) Level 2 START genetics study + genetics studies for opioid dependence 36 (4.5%) Level 3 Level 2 + substance abuse and/or related medical problems 205 (25.5%) Level 4 START genetics study + all other genetics research 492 (61.2%) Table 2. Levels of Consent As can bee seen in Figure 1, the majority of participants consented to the most liberal use of their genetic material. Figure 1. Participant Level of Consent Across Site 0 20 40 60 80 100 Mostconservative Mostliberal % Participants
-
Upload
fuller-santana -
Category
Documents
-
view
13 -
download
0
description
Feasibility of Conducting Genetics Research at Community Treatment Programs. Sonne SC 1 , Gentilin, SM 1 , Sampson R 1 , DeVane, CL 1 , Thomas, C 2 ,, Berrettini, W 3. - PowerPoint PPT Presentation
Transcript of Feasibility of Conducting Genetics Research at Community Treatment Programs
Feasibility of Conducting Genetics Research at Community Treatment ProgramsSonne SC1, Gentilin, SM1, Sampson R1, DeVane, CL1, Thomas, C2,, Berrettini, W3
1Medical University of South Carolina, 2University of California, Los Angeles, 3University of Pennsylvania School of Medicine
ABSTRACT: The addition of genetics research to pharmacotherapy trials is becoming more and more common. However, there has been some concern among community treatment providers that genetics research would be unacceptable to their clients. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting an add-on genetics substudy to a pharmacotherapy trial comparing the effects of long-term methadone and buprenorphine on liver function (Starting Treatment with Agonist Replacement Therapies, or START). The genetics substudy is exploratory in nature, with three main goals: 1) To better understand the potential genetic influence on opioid addiction (wk 2 sample); 2) To better understand how opioid dependent individuals metabolize buprenorphine and methadone (wk 12 sample); and 3) To evaluate feasibility of conducting a genetics sub-study within the CTN. Although data are still being collected to accomplish the first two goals, there is good evidence to support the feasibility of collecting genetic samples for analysis through the CTN. To date, all 8 of the START research sites have submitted samples for this substudy. Of the START participants eligible to enroll in the genetics substudy to date, 892 have been approached to participate and 846 consented. There have been 815 blood samples obtained for the week 2 sample, which goes to the NIDA repository, and 644 samples obtained and sent (at week 12) to MUSC for pharmacogenetic analysis. The genetics substudy has 4 different levels of consent so that participants can choose how their samples may be used in the future. Most participants (79%) have agreed to the most liberal use of their samples. Taken together, these data suggest that individuals in community treatment settings are willing to participate in genetic studies on addiction.
INTRODUCTION
METHODS
RESULTS RESULTS (Continued)
CONCLUSIONS / DISCUSSION
Although the study of genetics can be successfully carried out within academic centers, the feasibility of implementing such a study within community treatment settings was unclear. The Clinical Trials Network (CTN) has implemented an ancillary study of genetics in conjunction with another ongoing CTN trial, Starting Treatment with Agonist Replacement Therapies, or START. Areas of interest were the ability to acquire necessary regulatory approvals across participating sites, the additional burden to research staff to execute the substudy, and the receptiveness of potential study participants to donate their genetic material for research purposes.
In addition to determining the feasibility of conducting a genetics substudy within the CTN, other aims of this project were to 1) obtain genetic samples to better understand the potential genetic influence on opioid addiction (wk 2 sample); and 2) to better understand how opioid dependent individuals metabolize buprenorphine and methadone (wk 12 sample). These samples were obtained during regularly scheduled START blood draws:
START study week 2: Participants provided three 7 ml tubes of blood that are sent to the Rutgers University Cell and DNA Repository for later analysis of the genetic influence on opioid addiction.
START study week 12: Participants provided one 7ml tube of blood and a urine sample to the Medical University of South Carolina’s Drug Disposition Laboratory to evaluate the pharmacogenetics of buprenorphine and methadone in opioid dependent individuals.
Subjects• All participants currently enrolled in the START study are eligible to participate in
the genetics sub-study.
Regulatory
• All 8 of the sites participating in the START study obtained IRB approval of the genetic substudy from their respective IRBs.
• Informed consent forms were separate documents from the START study.
• Participants received on average $25 compensation for each of the two visits when genetics samples were collected. Amount of remuneration varied slightly by site.
Support
• A 42 page Operations Manual was developed in addition to the protocol to provide specific detail to the sites regarding study procedures.
• Web based group trainings were initially held prior to study initiation and individual training was conducted via conference call for new staff as needed
• A member of the genetics team attends regularly scheduled START conference calls with the sites to discuss issues related to the genetics study and provide ongoing support.
Table 2 describes the level of consent chosen by the 804 participants who supplied at least a valid week 2 sample. Of note, level 3 was the highest level of consent approved by the IRB for 2 sites. These 2 sites represented 142 (69.2%) of the 205 who consented at this level.
Site # Invited # Refused % Consented # Week 2 Samples Collected
# Week 12 Samples Collected
Site ASite BSite CSite DSite ESite FSite GSite H
All Sites
1051481397748
15513090
892
129070
1224
46 (5%)
89%94%
100%91%
100%92%98%96%
95%
921351366747
13512380
815
711081224835
1069955
644
Table 1. Genetics Recruitment by Site
• These data suggest that individuals seeking treatment for substance abuse in community treatment settings are willing to participate in a genetics study.
• Most participants willingly consent to the most liberal use of their genetic material including storage of samples indefinitely for future use.
• Although this study is ongoing, progress to date suggests it is feasible to conduct a genetics study through the NIDA Clinical Trials Network.
• Site staff received significant training and support from the START lead team in conjunction with the genetics researchers, which has aided in the successful conduct of this trial.
• Acceptability of genetic testing by community treatment program staff as well as research staff may play an important role in the level of consent given by research participants.
• The burden to participants was minimized by having genetics samples obtained at the same time as regularly scheduled START blood draws
Sponsored by the National Drug Abuse Treatment Clinical Trials Network
As can be seen in Table 1, the majority of START participants invited to be in the genetics substudy agreed and signed informed consent.
The decrease in the number of samples collected between Week 2 and Week 12 was largely due to attrition of participants from the START study. Study participants who drop out of START are no longer eligible to continue in the genetics study.
Consent Levels # Participants (%)Level 1START genetics study only
71 (8.8%)
Level 2START genetics study + genetics studies for opioid dependence
36 (4.5%)
Level 3Level 2 + substance abuse and/or related medical problems
205 (25.5%)
Level 4START genetics study + all other genetics research
492 (61.2%)
Table 2. Levels of ConsentAs can bee seen in Figure 1, the majority of participants consented to the most liberal use of their genetic material.
Figure 1. Participant Level of Consent Across Sites
0
20
40
60
80
100Most conservative
Most liberal
% P
arti
cip
ants
