Opioid detoxification via single 7-day application of a buprenorphine transdermal patch: an open-label evaluation.
BACKGROUND
Managed withdrawal (i.e., detoxification) from opioid dependence is a widespread clinical procedure that is a necessary step for those pursuing abstinence. Buprenorphine is one effective detoxification treatment, however, consensus regarding effective detoxification procedures is lacking.


OBJECTIVE
This study evaluated the efficacy of a buprenorphine transdermal formulation (i.e., patch) in suppressing opioid withdrawal, its safety and tolerability, and its biodelivery when applied for 7 days.


METHODS
Physically dependent opioid (heroin) users (n = 12) completed a 10-day opioid detoxification in a residential research unit. Each received a single patch application that remained in place for 7 days. Blood samples were drawn prior to patch application and once daily thereafter. Assessments, four times daily, included: the amount of rescue medications ordered to treat withdrawal discomfort; self-report and observer ratings of opioid withdrawal and agonist effects; and vital sign measures.


RESULTS
Overall, the patch appeared safe and well-tolerated. Buprenorphine plasma levels peaked 48 h after patch application at 0.59 ng/ml. Indices of withdrawal (self-reports, observer ratings, rescue medication) were significantly reduced within 24 h of patch application, continued to decline thereafter, and did not reappear following patch removal.


CONCLUSIONS
This study confirms that transdermal buprenorphine is safe and clinically effective, and suggests that a 7-day application may provide an effective and comfortable means of detoxification. This patch formulation would appear to be a useful opioid detoxification treatment by reducing compliance concerns, and administering buprenorphine in a formulation less likely to be diverted to illicit use.
Lanier
Ryan K
RK
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Umbricht
Annie
A
Harrison
Joseph A
JA
Nuwayser
Elie S
ES
Bigelow
George E
GE
D000279:Administration, Cutaneous; D000328:Adult; D019540:Area Under Curve; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D005260:Female; D006801:Humans; D004091:Hydromorphone / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D009294:Narcotics / Q000008:administration & dosage / Q000627:therapeutic use; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000523:psychology; D013375:Substance Withdrawal Syndrome / Q000523:psychology
D009292:Narcotic Antagonists; D009294:Narcotics; D002047:Buprenorphine; D004091:Hydromorphone