Optimising the benefits of unobserved dose administration for stable opioid maintenance patients: follow-up of a randomised trial.
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.


OBJECTIVE
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.
Bell
James R
JR
The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010, Australia. james.bell@iop.kcl.ac.uk <james.bell@iop.kcl.ac.uk>
Ryan
Anni
A
Mutch
Carolyn
C
Batey
Robert
R
Rea
Felicity
F
D000328:Adult; D001315:Australia; D002047:Buprenorphine / Q000008:administration & dosage / Q000627:therapeutic use; D023801:Directly Observed Therapy / Q000379:methods* / Q000523:psychology; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008691:Methadone / Q000627:therapeutic use; D009270:Naloxone / Q000008:administration & dosage / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000523:psychology / Q000534:rehabilitation*; D010352:Patient Dropouts / Q000523:psychology / Q000706:statistics & numerical data; D016016:Proportional Hazards Models; D055502:Secondary Prevention; D012646:Self Administration / Q000379:methods* / Q000523:psychology; D016320:Substance Abuse Treatment Centers; D016896:Treatment Outcome
D004338:Drug Combinations; D009292:Narcotic Antagonists; D009270:Naloxone; D002047:Buprenorphine; D008691:Methadone