Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience.
In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opioid-dependent men and women were randomized to a thirteen-day buprenorphine-naloxone taper regimen for short-term opioid detoxification. The 234 buprenorphine-naloxone patients averaged 37 years old and used mostly intravenous heroin. Direct and rapid induction onto buprenorphine-naloxone was safe and well tolerated. Most patients (83%) received 8 mg buprenorphine-2 mg naloxone on the first day and 90% successfully completed induction and reached a target dose of 16 mg buprenorphine-4 mg naloxone in three days. Medication compliance and treatment engagement was high. An average of 81% of available doses was ingested, and 68% of patients completed the detoxification. Most (80.3%) patients received some ancillary medications with an average of 2.3 withdrawal symptoms treated. The safety profile of buprenorphine-naloxone was excellent. Of eighteen serious adverse events reported, only one was possibly related to buprenorphine-naloxone. All providers successfully integrated buprenorphine-naloxone into their existing treatment milieus. Overall, data from the CTN field experience suggest that buprenorphine-naloxone is practical and safe for use in diverse community treatment settings, including those with minimal experience providing opioid-based pharmacotherapy and/or medical detoxification for opioid dependence.
Amass
Leslie
L
Friends Research Institute, Inc., 11075 Santa Monica Boulevard, Suite 200, Los Angeles, CA 90025, USA. lamass@friendsresearch.org
Ling
Walter
W
Freese
Thomas E
TE
Reiber
Chris
C
Annon
Jeffrey J
JJ
Cohen
Allan J
AJ
McCarty
Dennis
D
Reid
Malcolm S
MS
Brown
Lawrence S
LS
Clark
Cynthia
C
Ziedonis
Douglas M
DM
Krejci
Jonathan
J
Stine
Susan
S
Winhusen
Theresa
T
Brigham
Greg
G
Babcock
Dean
D
Muir
Joan A
JA
Buchan
Betty J
BJ
Horton
Terry
T
D000286:Administration, Sublingual; D000328:Adult; D002047:Buprenorphine / Q000009:adverse effects / Q000627:therapeutic use*; D003153:Community Health Services; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009270:Naloxone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D009294:Narcotics / Q000009:adverse effects / Q000627:therapeutic use*; D009316:National Institutes of Health (U.S.); D009293:Opioid-Related Disorders / Q000534:rehabilitation*; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence; D012047:Rehabilitation Centers; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy / Q000209:etiology; D013997:Time Factors; D014481:United States
D009292:Narcotic Antagonists; D009294:Narcotics; D009270:Naloxone; D002047:Buprenorphine