0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Original Investigation |

A Randomized, Double-blind Evaluation of Buprenorphine Taper Duration in Primary Prescription Opioid Abusers

Stacey C. Sigmon, PhD1,2; Kelly E. Dunn, PhD2; Kathryn Saulsgiver, PhD1; Mollie E. Patrick, MA2; Gary J. Badger, MS3; Sarah H. Heil, PhD1,2; John R. Brooklyn, MD1; Stephen T. Higgins, PhD1,2
[+] Author Affiliations
1Department of Psychiatry, University of Vermont, Burlington
2Department of Psychology, University of Vermont, Burlington
3Department of Medical Biostatistics, University of Vermont, Burlington
JAMA Psychiatry. 2013;70(12):1347-1354. doi:10.1001/jamapsychiatry.2013.2216.
Text Size: A A A
Published online

Importance  Although abuse of prescription opioids (POs) is a significant public health problem, few experimental studies have investigated the treatment needs of this growing population.

Objective  To evaluate, following brief stabilization with a combination of buprenorphine hydrochloride and naloxone hydrochloride dihydrate, the relative efficacy of 1-, 2-, and 4-week buprenorphine tapering regimens and subsequent naltrexone hydrochloride therapy in PO-dependent outpatients.

Design, Setting, and Participants  A double-blind, 12-week randomized clinical trial was conducted in an outpatient research clinic. Following a brief period of buprenorphine stabilization, 70 PO-dependent adults were randomized to receive 1-, 2-, or 4-week tapers followed by naltrexone therapy.

Intervention  During phase 1 (weeks 1-5 after randomization), participants visited the clinic daily; during phase 2 (weeks 6-12), visits were reduced to thrice weekly. Participants received behavioral therapy and urine toxicology testing throughout the trial.

Main Outcomes and Measures  The percentage of participants negative for illicit opioid use, retention, naltrexone ingestion, and favorable treatment response (ie, retained in treatment, opioid abstinent, and receiving naltrexone at the end of the study).

Results  Opioid abstinence at the end of phase 1 was greater in the 4-week compared with the 2- and 1-week taper conditions (P = .02), with 63% (n = 14), 29% (n = 7), and 29% (n = 7) of participants abstinent in the 4-, 2-, and 1-week conditions, respectively. Abstinence at the end of phase 2 was also greater in the 4-week compared with the 2- and 1-week conditions (P = .03), with 50% (n = 11), 16% (n = 4), and 20% (n = 5) of participants abstinent in the 4-, 2-, and 1-week conditions, respectively. There were more treatment responders in the 4-week condition (P = .03), with 50% (n = 11), 17% (n = 4), and 21% (n = 5) of participants in the 4-, 2-, and 1-week groups considered responders at the end of treatment, respectively. Retention and naltrexone ingestion also were superior in the 4-week vs briefer tapers (both P = .04). Experimental condition (ie, taper duration) was the strongest predictor of treatment response, followed by buprenorphine stabilization dose.

Conclusions and Relevance  This study represents a rigorous experimental evaluation of outpatient buprenorphine stabilization, brief taper, and naltrexone maintenance for treatment of PO dependence. Results suggest that a meaningful subset of PO-dependent outpatients may respond positively to a 4-week taper plus naltrexone maintenance intervention.

Trial Registration  clinicaltrials.gov Identifier: NCT00719095

Figures in this Article

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

First Page Preview

View Large
First page PDF preview

Figures

Place holder to copy figure label and caption
Figure 1.
A Schematic of the Experimental Design, Including Stabilization, Taper, and Naltrexone Maintenance Phases

Arrows represent participant randomization following stabilization into 1 of 3 experimental conditions prior to initiation of the buprenorphine (BUP) taper. MWF indicates Monday, Wednesday, and Friday.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.
Consolidated Standards for Reporting of Trials Flow Diagram of Participants

A schematic of participant enrollment, randomization, and study completion.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 3.
Effects of Buprenorphine Taper Duration on Illicit Opioid Abstinence Achieved

Data points represent the percentage of opioid-negative urine samples submitted at each consecutive urine-sample visit before and after randomization. Data are presented for the entire group of participants at intake and stabilization and for each experimental group after randomization: 1-week, 2-week, and 4-week taper conditions.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 4.
Effects of Buprenorphine Taper Duration on Treatment Retention and Naltrexone Ingestion at the End of Each Study Phase

Data are presented for 1-week, 2-week, and 4-week taper conditions.

Graphic Jump Location

Tables

References

Correspondence

CME
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
Submit a Comment

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 3

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

Related Content

Customize your page view by dragging & repositioning the boxes below.

See Also...
Articles Related By Topic
Related Collections
PubMed Articles
Jobs
brightcove.createExperiences();