Transcript Open poster - CTN Dissemination Library

Feasibility of Conducting Genetics Research at Community Treatment Programs
Sonne
1Medical
1
SC ,
Gentilin,
University of South Carolina,
1
SM ,
Sampson
2University
1
R,
DeVane,
1
CL ,
of California, Los Angeles,
Thomas,
3University
2
C ,,
Berrettini,
3
W
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
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.
815
644
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.
20
0
H
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.
95%
te
Si
•
46 (5%)
40
G
Web based group trainings were initially held prior to study initiation and
individual training was conducted via conference call for new staff as needed
892
60
te
Si
•
All Sites
80
F
A 42 page Operations Manual was developed in addition to the protocol to
provide specific detail to the sites regarding study procedures.
71
108
122
48
35
106
99
55
te
Si
•
92
135
136
67
47
135
123
80
E
Support
89%
94%
100%
91%
100%
92%
98%
96%
te
Si
Participants received on average $25 compensation for each of the two visits
when genetics samples were collected. Amount of remuneration varied slightly
by site.
12
9
0
7
0
12
2
4
D
•
105
148
139
77
48
155
130
90
Most conservative
Most liberal
te
Si
Informed consent forms were separate documents from the START study.
Site A
Site B
Site C
Site D
Site E
Site F
Site G
Site H
100
C
•
# Week 12
Samples
Collected
te
Si
All 8 of the sites participating in the START study obtained IRB approval of the
genetic substudy from their respective IRBs.
# Week 2
Samples
Collected
B
•
# Invited # Refused % Consented
te
Si
Regulatory
Site
Figure 1. Participant Level of Consent Across Sites
A
Subjects
•
All participants currently enrolled in the START study are eligible to participate in
the genetics sub-study.
Table 1. Genetics Recruitment by Site
te
Si
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.
RESULTS (Continued)
% Participants
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.
RESULTS
Table 2. Levels of Consent
Consent Levels
Level 1
START genetics study only
Level 2
START genetics study + genetics studies for
opioid dependence
# Participants (%)
71 (8.8%)
As can bee seen in Figure 1, the majority of participants consented to the most liberal use of their
genetic material.
CONCLUSIONS / DISCUSSION
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%)
• 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.
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 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