Abstract
Methods
We assessed HRQOL changes in a substudy of a pharmacokinetic study that compared buprenorphine oral tablet and liquid dosage
formulations over 16 weeks. Individuals, aged 18–65 years, were screened for opioid dependence. They were excluded if they
would not agree to birth control or had a serious medical condition. Subjects received psychosocial counseling and weekly
group therapy. The SF-36 was administered upon enrollment and at 4-week intervals. We used the SF-6D to estimate HUs. We performed
intention to treat (ITT) analyses based on the last observation available for each subject. Paired t tests of each domain
and HU, limited to remaining patients at each 4-week interval, were also conducted.
formulations over 16 weeks. Individuals, aged 18–65 years, were screened for opioid dependence. They were excluded if they
would not agree to birth control or had a serious medical condition. Subjects received psychosocial counseling and weekly
group therapy. The SF-36 was administered upon enrollment and at 4-week intervals. We used the SF-6D to estimate HUs. We performed
intention to treat (ITT) analyses based on the last observation available for each subject. Paired t tests of each domain
and HU, limited to remaining patients at each 4-week interval, were also conducted.
Results
Of 96 subjects enrolled, cumulative dropouts over time resulted in 80, 69, 59, and 44 subjects remaining at 4, 8, 12, and
16 weeks. There were no significant differences in opioid-positive urines, dropout rates, or dosage changes between formulations.
In the ITT analyses, HRQOL improvements over time were bodily pain (62.1 vs. 69.1, P = 0.017), vitality (49.8 vs. 56.5, P = 0.001), mental health (59.9 vs. 66.0, P = 0.001), social function (66.4 vs. 74.7, P = 0.001), role emotional (59.4 vs. 71.9, P = 0.003), role physical (60.9 vs. 70.6, P = 0.005), and mental component summary (41.9 vs. 45.4, P<0.001). HU scores also improved (0.674 vs. 0.715, P = 0.001). Results from paired t tests, with only concurrently enrolled patients, showed similar improvements from baseline to 4, 8, 12, or 16 weeks.
16 weeks. There were no significant differences in opioid-positive urines, dropout rates, or dosage changes between formulations.
In the ITT analyses, HRQOL improvements over time were bodily pain (62.1 vs. 69.1, P = 0.017), vitality (49.8 vs. 56.5, P = 0.001), mental health (59.9 vs. 66.0, P = 0.001), social function (66.4 vs. 74.7, P = 0.001), role emotional (59.4 vs. 71.9, P = 0.003), role physical (60.9 vs. 70.6, P = 0.005), and mental component summary (41.9 vs. 45.4, P<0.001). HU scores also improved (0.674 vs. 0.715, P = 0.001). Results from paired t tests, with only concurrently enrolled patients, showed similar improvements from baseline to 4, 8, 12, or 16 weeks.
- Content Type Journal Article
- Pages 1-7
- DOI 10.1007/s11136-011-0027-0
- Authors
- Dennis W. Raisch, University of New Mexico, Albuquerque, NM, USA
- Heather M. Campbell, Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy, Albuquerque, NM, USA
- David A. Garnand, Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy, Albuquerque, NM, USA
- Mark A. Jones, Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy, Albuquerque, NM, USA
- Mike R. Sather, University of New Mexico, Albuquerque, NM, USA
- Rupali Naik, Allergan, Inc., Irvine, CA, USA
- Walter Ling, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA
- Journal Quality of Life Research
- Online ISSN 1573-2649
- Print ISSN 0962-9343