Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence.
BACKGROUND
The optimal level of counseling and frequency of attendance for medication distribution has not been established for the primary care, office-based buprenorphine-naloxone treatment of opioid dependence.


METHODS
We conducted a 24-week randomized, controlled clinical trial with 166 patients assigned to one of three treatments: standard medical management and either once-weekly or thrice-weekly medication dispensing or enhanced medical management and thrice-weekly medication dispensing. Standard medical management was brief, manual-guided, medically focused counseling; enhanced management was similar, but each session was extended. The primary outcomes were the self-reported frequency of illicit opioid use, the percentage of opioid-negative urine specimens, and the maximum number of consecutive weeks of abstinence from illicit opioids.


RESULTS
The three treatments had similar efficacies with respect to the mean percentage of opioid-negative urine specimens (standard medical management and once-weekly medication dispensing, 44 percent; standard medical management and thrice-weekly medication dispensing, 40 percent; and enhanced medical management and thrice-weekly medication dispensing, 40 percent; P=0.82) and the maximum number of consecutive weeks during which patients were abstinent from illicit opioids. All three treatments were associated with significant reductions from baseline in the frequency of illicit opioid use, but there were no significant differences among the treatments. The proportion of patients remaining in the study at 24 weeks did not differ significantly among the patients receiving standard medical management and once-weekly medication dispensing (48 percent) or thrice-weekly medication dispensing (43 percent) or enhanced medical management and thrice-weekly medication dispensing (39 percent) (P=0.64). Adherence to buprenorphine-naloxone treatment varied; increased adherence was associated with improved treatment outcomes.


CONCLUSIONS
Among patients receiving buprenorphine-naloxone in primary care for opioid dependence, the efficacy of brief weekly counseling and once-weekly medication dispensing did not differ significantly from that of extended weekly counseling and thrice-weekly dispensing. Strategies to improve buprenorphine-naloxone adherence are needed. (ClinicalTrials.gov number, NCT00023283 [ClinicalTrials.gov].).
Fiellin
David A
DA
Department of Internal Medicine, Yale University School of Medicine, New Haven, Conn 06520, USA. david.fiellin@yale.edu
Pantalon
Michael V
MV
Chawarski
Marek C
MC
Moore
Brent A
BA
Sullivan
Lynn E
LE
O'Connor
Patrick G
PG
Schottenfeld
Richard S
RS
D000328:Adult; D002047:Buprenorphine / Q000627:therapeutic use*; D019970:Cocaine-Related Disorders / Q000150:complications / Q000453:epidemiology; D003131:Combined Modality Therapy; D003376:Counseling; D005260:Female; D006801:Humans; D008297:Male; D009270:Naloxone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000150:complications / Q000188:drug therapy / Q000628:therapy*
D009292:Narcotic Antagonists; D009270:Naloxone; D002047:Buprenorphine