Improved Strategies for Outpatient Opioid Detoxification

Completed · Phase 1

Conditions studied: Opioid Dependence

In brief

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.

Key facts

Study ID: NCT01377610
Run by: New York State Psychiatric Institute
People needed: 150
Starts: 2011-06-01
Expected to finish: 2017-12-01
Last updated by the study team: 2018-05-21

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Meets DSM-IV criteria for current opiate dependence disorder of at least six months duration, supported by urine toxicology OR COWS score > or =6 OR Naloxone Challenge .
Seeking treatment for opioid dependence.
In otherwise good health based on complete medical history and physical examination
Able to give written informed consent.

You may not qualify if…

Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).
Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists
Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT > 3 times normal, AIDS, unstable diabetes.
Severe psychiatric illness (psychotic disorder, major depression, suicide risk or 1 or more suicide attempts within the past year.)
Physiologically dependent on alcohol or sedative-hypnotics
History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
Chronic pain requiring opioid analgesia or anticipated surgery necessitating opioid medications
AIDS dementia or other chronic organic mental disorder
Pregnancy, lactation, failure to use contraception
History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.

Where it is running

Substance Treatment and Research Service (STARS), Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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