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. 2008 Jun;198(2):149-58.
doi: 10.1007/s00213-008-1105-z. Epub 2008 Mar 9.

Opioid detoxification via single 7-day application of a buprenorphine transdermal patch: an open-label evaluation

Ryan K Lanier  1 , Annie Umbricht, Joseph A Harrison, Elie S Nuwayser, George E Bigelow
Affiliations

Opioid detoxification via single 7-day application of a buprenorphine transdermal patch: an open-label evaluation

Ryan K Lanier et al. Psychopharmacology (Berl). 2008 Jun.

Abstract

Rationale: 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.

Objectives: 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.

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Conflict of interest statement

Disclosure Bigelow has received, through his university, research contract support from Biotek, Inc., from Titan Pharmaceuticals, and from Purdue Pharma LLP, all of which have been developing buprenorphine products. Nuwayser is an officer of, and has financial interest in Biotek, Inc. Lanier, Umbricht, and Harrison report no conflicting interests.

Figures

Fig. 1
Fig. 1
Mean plasma concentrations of buprenorphine (triangles) and norbuprenorphine (circles) are shown for the 3- (unfilled symbols) and 7- (filled symbols) day patch application studies (top panel). Individual plasma concentrations of buprenorphine (ng/ml) for the 12 volunteers who completed the 7-day study are shown (bottom panel)
Fig. 2
Fig. 2
Participants’ mean visual analog scale (VAS) ratings of withdrawal strength are shown for the 3- (unfilled circles) and 7- (filled circles) day patch application studies (top panel). Volunteers also rated “Do you feel any withdrawal discomfort,” which resulted in an almost identical set of values (not shown). Mean participant self-report ratings of withdrawal as measured by a 21-item Withdrawal Adjective Rating Scale are shown for the 3- and 7-day patch application studies (middle panel). Mean observer ratings of withdrawal as measured using a modified Himmelsbach withdrawal severity scale are shown for the 3- and 7-day patch application studies (bottom panel). Vertical bars represent SEM
Fig. 3
Fig. 3
The mean number of times rescue medications were administered per day for the 3- (unfilled symbols) and 7- (filled symbols) day patch application studies are shown. Hydromorphone is represented by the triangles while all other pre-planned rescue medications (hydroxyzine, loperamide, and clonidine) are represented collectively by the circles. Vertical bars represent SEM
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