NCT01377610

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

6.5 years

First QC Date

June 20, 2011

Last Update Submit

May 17, 2018

Conditions

Opioid Dependence

Keywords

Outpatient detoxificationOpioid dependenceNaltrexoneVivitrolBuprenorphine

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients in each group successfully inducted onto Vivitrol

    Comparison of the percentage of patients assigned to each detoxification group (oral naltrexone vs. buprenorphine) who receive Vivitrol at the completion of detoxification.

    Completion of 7-day detoxification

Study Arms (2)

Buprenorphine

ACTIVE COMPARATOR

Standard 7-day buprenorphine induction and gradual taper from 8 mg to 0 mg followed on day 15 by Vivitrol injection

Drug: BuprenorphineDrug: Vivitrol

Oral naltrexone

ACTIVE COMPARATOR

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. Followed on day 8 by Vivitrol injection.

Drug: oral naltrexoneDrug: BuprenorphineDrug: Vivitrol

Interventions

oral naltrexoneDRUG

Following detoxification with buprenorphine (one dy of 8 mg) followed by oral naltrexone (ascending taper to 25 mg), participants will receive Vivitrol injection on Day 8. Behavioral therapy sessions will be offered for five weeks.

Also known as: buprenorphine and oral naltrexone followed by Vivitrol
Oral naltrexone
BuprenorphineDRUG

Following detoxification with buprenorphine \[8-mg buprenorphine (Day 1) tapering to 0 mg (Day 7)\] participants will receive Vivitrol injection on Day 15. Behavioral therapy sessions will be offered for five weeks.

BuprenorphineOral naltrexone
VivitrolDRUG

dose of long-acting injectable naltrexone (Vivitrol 380 mg i.m. Injection)

Also known as: long-acting injectable naltrexone
BuprenorphineOral naltrexone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substance Treatment and Research Service (STARS), Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

  • Sullivan M, Bisaga A, Pavlicova M, Choi CJ, Mishlen K, Carpenter KM, Levin FR, Dakwar E, Mariani JJ, Nunes EV. Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine. Am J Psychiatry. 2017 May 1;174(5):459-467. doi: 10.1176/appi.ajp.2016.16050548. Epub 2017 Jan 10.

    PMID: 28068780DERIVED

Related Links

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

NaltrexoneBuprenorphinevivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Adam Bisaga, M.D.

    Columbia University and NYSPI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Psychiatrist

Study Record Dates

First Submitted

June 20, 2011

First Posted

June 21, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

US(1)