TY - JOUR
KW - Adult
KW - Australia
KW - Buprenorphine/administration & dosage/therapeutic use
KW - Directly Observed Therapy/methods/psychology
KW - Drug Administration Schedule
KW - Drug Combinations
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Methadone/therapeutic use
KW - Naloxone/administration & dosage/therapeutic use
KW - Narcotic Antagonists/administration & dosage/therapeutic use
KW - Opioid-Related Disorders/psychology/rehabilitation
KW - Patient Dropouts/psychology/statistics & numerical data
KW - Proportional Hazards Models
KW - Secondary prevention
KW - Self Administration/methods/psychology
KW - Substance Abuse Treatment Centers
KW - Treatment Outcome
AU - J. R. Bell
AU - A. Ryan
AU - C. Mutch
AU - R. Batey
AU - F. Rea
A1 - 
AB - BACKGROUND: The registration of combination buprenorphine/naloxone, a formulation designed to reduce risk of diversion, has led some Australian jurisdictional authorities to allow treatment without direct observation of dosing for stable, opioid-dependent patients. AIM: To compare two approaches (1) initiating treatment with observed dosing, then allowing patients who demonstrate stability to change to unobserved dosing; or (2) initiating patients with unobserved dosing, subsequently requiring those who fail to stabilize to change to observed treatment. METHODS: This study builds on an RCT comparing efficacy of observed and unobserved treatment at 3 months. At the conclusion of the RCT, clinically "stable" subjects were allocated to continue without observed dosing, while those who did not demonstrate stability were allocated to observed dosing. Subjects were followed for a further 3 months. Primary end-point was retention in treatment. RESULTS: Of 119 subjects randomised, 70 were retained in treatment to 3 months. Forty-five stable subjects were allocated to unobserved dosing, 25 to observation. Unstable subjects allocated to observed treatment were more likely to drop out thereafter (OR 2.14, 95% CI 1.09-4.19). There was a non-significant trend for people initiated with observed dosing to be better retained during the allocation phase; at 6 months, 13 subjects (22%) from the original unobserved group, and 22 (34%) from the observed group, were retained in treatment (chi2=2.10, 1 df, p=0.15). CONCLUSIONS: Withdrawal of unobserved doses led to marked attrition from treatment. If access to unobserved dosing is to be restricted to stable patients, it appears preferable to initiate dosing with observation and allow unobserved doses for people who successfully stabilize, than to initiate with unobserved doses and transfer unstable patients to observation.
BT - Drug and alcohol dependence
C5 - Opioids & Substance Use
CP - 1-2
CY - Ireland
DO - 10.1016/j.drugalcdep.2008.02.012
IS - 1-2
JF - Drug and alcohol dependence
N2 - BACKGROUND: The registration of combination buprenorphine/naloxone, a formulation designed to reduce risk of diversion, has led some Australian jurisdictional authorities to allow treatment without direct observation of dosing for stable, opioid-dependent patients. AIM: To compare two approaches (1) initiating treatment with observed dosing, then allowing patients who demonstrate stability to change to unobserved dosing; or (2) initiating patients with unobserved dosing, subsequently requiring those who fail to stabilize to change to observed treatment. METHODS: This study builds on an RCT comparing efficacy of observed and unobserved treatment at 3 months. At the conclusion of the RCT, clinically "stable" subjects were allocated to continue without observed dosing, while those who did not demonstrate stability were allocated to observed dosing. Subjects were followed for a further 3 months. Primary end-point was retention in treatment. RESULTS: Of 119 subjects randomised, 70 were retained in treatment to 3 months. Forty-five stable subjects were allocated to unobserved dosing, 25 to observation. Unstable subjects allocated to observed treatment were more likely to drop out thereafter (OR 2.14, 95% CI 1.09-4.19). There was a non-significant trend for people initiated with observed dosing to be better retained during the allocation phase; at 6 months, 13 subjects (22%) from the original unobserved group, and 22 (34%) from the observed group, were retained in treatment (chi2=2.10, 1 df, p=0.15). CONCLUSIONS: Withdrawal of unobserved doses led to marked attrition from treatment. If access to unobserved dosing is to be restricted to stable patients, it appears preferable to initiate dosing with observation and allow unobserved doses for people who successfully stabilize, than to initiate with unobserved doses and transfer unstable patients to observation.
PP - Ireland
PY - 2008
SN - 0376-8716; 0376-8716
SP - 183
EP - 186
EP - 
T1 - Optimising the benefits of unobserved dose administration for stable opioid maintenance patients: follow-up of a randomised trial
T2 - Drug and alcohol dependence
TI - Optimising the benefits of unobserved dose administration for stable opioid maintenance patients: follow-up of a randomised trial
U1 - Opioids & Substance Use
U2 - 18423901
U3 - 10.1016/j.drugalcdep.2008.02.012
VL - 96
VO - 0376-8716; 0376-8716
Y1 - 2008
ER -