Improved Strategies for Outpatient Opioid Detoxification
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
The investigators will randomize 210 opioid-dependent participants to one of two outpatient
detoxification strategies: (1) a standard 7-day buprenorphine induction and gradual taper
from 8 mg to 0 mg vs. (2) 7-day oral naltrexone induction; both groups will receive a single
administration of a Vivitrol injection: at Day 8 for the naltrexone induction group and Day
15 for the buprenorphine group. The naltrexone arm is a modification of our current inpatient
naltrexone induction procedure, consisting of a single day of buprenorphine followed by a
washout day and 4 days of ascending oral naltrexone doses, prior to administering a dose of
injectable naltrexone on Day 8. All participants will receive an intensive behavioral therapy
for five weeks and will be followed for the subsequent 8 weeks to assess the longer-term
outcome of the initial treatment. The primary outcome will be percentage of patients in each
group successfully inducted onto Vivitrol. Key secondary outcomes will be 2-week abstinence
at Weeks 4-5 (3rd and 4th weeks after Vivitrol injection), rates of completion of the 8-day
detoxification, and percentage of patients in each group who return for additional Vivitrol
injections in post-study follow-up. The main goal of this Stage 1a pilot study is to develop
an improved outpatient opioid detoxification strategy, with particular relevance to newly
diagnosed heroin addicts and prescription opioid abusers not seeking long-term agonist
maintenance.
Specific Aim #1: To develop procedures for outpatient opioid detoxification which include
naltrexone to facilitate detoxification.
Specific Aim #2: To compare injectable naltrexone induction rates between the naltrexone and
buprenorphine groups following short-term outpatient opioid detoxification approach for
initiating treatment for opioid dependence.