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Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

Primary Purpose

Opioid-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Opioid-Related Disorders

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males/Females, ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependent on etoh or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Sites / Locations

  • Friends Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

buprenorphine

buprenorphine and ultra-low dose naloxone

Arm Description

depot buprenorphine

depot buprenorphine and naloxone

Outcomes

Primary Outcome Measures

Opiate craving
opiate craving is measured on each test day.
Opiate withdrawal symptoms
opiate withdrawal symptoms are documented for each test day

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
January 27, 2016
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000299
Brief Title
Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2
Official Title
Rapid Opiate Detoxification & Naltrexone Induction Using Bup.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to develop a clinical protocol to detoxify patients from opiates to naltrexone using buprenorphine and to develop pilot data for a grant application for a controlled study of the efficacy of the new clinical protocol for outpatients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
Opioid-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
buprenorphine
Arm Type
Active Comparator
Arm Description
depot buprenorphine
Arm Title
buprenorphine and ultra-low dose naloxone
Arm Type
Experimental
Arm Description
depot buprenorphine and naloxone
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Primary Outcome Measure Information:
Title
Opiate craving
Description
opiate craving is measured on each test day.
Time Frame
10 test days
Title
Opiate withdrawal symptoms
Description
opiate withdrawal symptoms are documented for each test day
Time Frame
10 test days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males/Females, ages 21-50. Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent. Exclusion Criteria: psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependent on etoh or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

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Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

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