search
Back to results

Cocaine Use Reduction With Buprenorphine (CURB)

Primary Purpose

Cocaine Dependence

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

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine-Related disorders, Cocaine, Substance-Related disorders, Opioid abuse, Opioid dependence, abuse, addiction, treatment, buprenorphine, naltrexone, Suboxone, Vivitrol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 to 65 years of age
  • In good general health
  • Meet Diagnostic and Statistical Manual (DSM)-IV criteria for cocaine dependence
  • Meet DSM-IV criteria for past-year opioid dependence OR past-year opioid abuse OR have past-year opioid use and a history of opioid dependence during the lifetime
  • Interested in receiving treatment for cocaine dependence
  • Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
  • Able to satisfy and comply with study procedures and requirements
  • If female of childbearing potential, willing to practice and effective method of birth control for the duration of the study

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Known allergy or sensitivity to study medications
  • Recent or ongoing treatment with medications that, in the judgment of the study medical clinician, could interact adversely with study drugs or interfere with study participation
  • Have a current pattern of alcohol, benzodiazepine, or other sedative-hypnotic use, as determined by the study medical clinician, which would preclude safe participation
  • Liver function test results greater than 5 times the upper limit of normal or other exclusionary clinical lab test values
  • Serious medical condition or acute psychiatric disorder that would make study participation difficult or unsafe
  • Pending action or situation that might prevent remaining in the area for the duration of the study

Sites / Locations

  • UCLA Integrated Substance Abuse Programs (ISAP)
  • Bay Area Addiction Research and Treatment (BAART)
  • Addiction Research and Treatment Services (ARTS)
  • Howard University Hospital
  • Atlanta VA Medical Center
  • Albert Einstein College of Medicine - Division of Substance Abuse
  • Bellevue Hospital Center
  • Maryhaven
  • CODA, Inc.
  • South Texas Veterans Health Care System
  • Recovery Centers of King County (RCKC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

BUP4+XR-NTX

BUP16+XR-NTX

PLB+XR-NTX

Arm Description

4mg buprenorphine plus naltrexone for 8 weeks of treatment

16mg buprenorphine plus naltrexone for 8 weeks of treatment

naltrexone for 8 weeks of treatment

Outcomes

Primary Outcome Measures

Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens
Self-reported days of cocaine use corroborated with urine drug screens (UDS).

Secondary Outcome Measures

Full Information

First Posted
July 25, 2011
Last Updated
October 1, 2021
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01402492
Brief Title
Cocaine Use Reduction With Buprenorphine
Acronym
CURB
Official Title
Cocaine Use Reduction With Buprenorphine (CURB)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence.
Detailed Description
This project will assess the utility of buprenorphine in the presence of naltrexone as a potential medication useful in reducing cocaine use, commencing a research direction of great importance to both theoretical and practical addiction medicine. Buprenorphine will be provided as sublingual buprenorphine+naloxone tablets (Suboxone®, "BUP"). Naltrexone will be provided as extended-release (XR) naltrexone by injection (Vivitrol®, "XR-NTX"). In this multi-center, double-blind, placebo-controlled trial, participants will randomly assigned to one of three medication conditions: 4mg buprenorphine plus naltrexone (BUP4+XR-NTX), 16mg buprenorphine plus naltrexone (BUP16+XR-NTX), or placebo plus naltrexone (PLB+XR-NTX) for 8 weeks of treatment. Participants will be scheduled for clinic visits three times weekly (for a total of 24 visits across the 8-week treatment period) for observed medication administration, provision of take-home medication, collection of safety, medical, drug use, psychological, and compliance measures. In addition, all participants will be scheduled for once-weekly individual Cognitive Behavioral Therapy (CBT) sessions. This protocol will explore the effects of these three medication conditions to test buprenorphine as a possible treatment for cocaine dependence. This study will advance the science, provide dosing information, and characterize the effects of the combination of the two medications in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Cocaine-Related disorders, Cocaine, Substance-Related disorders, Opioid abuse, Opioid dependence, abuse, addiction, treatment, buprenorphine, naltrexone, Suboxone, Vivitrol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BUP4+XR-NTX
Arm Type
Experimental
Arm Description
4mg buprenorphine plus naltrexone for 8 weeks of treatment
Arm Title
BUP16+XR-NTX
Arm Type
Experimental
Arm Description
16mg buprenorphine plus naltrexone for 8 weeks of treatment
Arm Title
PLB+XR-NTX
Arm Type
Active Comparator
Arm Description
naltrexone for 8 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Buprenorphine + Naltrexone
Other Intervention Name(s)
Suboxone, buprenorphine/naloxone, Vivitrol, extended release injectable naltrexone
Intervention Description
Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.
Intervention Type
Drug
Intervention Name(s)
Placebo + Naltrexone
Other Intervention Name(s)
Vivitrol, extended release injectable naltrexone
Intervention Description
Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.
Primary Outcome Measure Information:
Title
Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens
Description
Self-reported days of cocaine use corroborated with urine drug screens (UDS).
Time Frame
final 30 days of Treatment Phase, study days 25-54

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 65 years of age In good general health Meet Diagnostic and Statistical Manual (DSM)-IV criteria for cocaine dependence Meet DSM-IV criteria for past-year opioid dependence OR past-year opioid abuse OR have past-year opioid use and a history of opioid dependence during the lifetime Interested in receiving treatment for cocaine dependence Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study Able to satisfy and comply with study procedures and requirements If female of childbearing potential, willing to practice and effective method of birth control for the duration of the study Exclusion Criteria: Pregnant or breastfeeding females Known allergy or sensitivity to study medications Recent or ongoing treatment with medications that, in the judgment of the study medical clinician, could interact adversely with study drugs or interfere with study participation Have a current pattern of alcohol, benzodiazepine, or other sedative-hypnotic use, as determined by the study medical clinician, which would preclude safe participation Liver function test results greater than 5 times the upper limit of normal or other exclusionary clinical lab test values Serious medical condition or acute psychiatric disorder that would make study participation difficult or unsafe Pending action or situation that might prevent remaining in the area for the duration of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew J. Saxon, M.D.
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Larissa J. Mooney, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Integrated Substance Abuse Programs (ISAP)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Bay Area Addiction Research and Treatment (BAART)
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Addiction Research and Treatment Services (ARTS)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Atlanta VA Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30345
Country
United States
Facility Name
Albert Einstein College of Medicine - Division of Substance Abuse
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Maryhaven
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
CODA, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
South Texas Veterans Health Care System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Recovery Centers of King County (RCKC)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26948856
Citation
Ling W, Hillhouse MP, Saxon AJ, Mooney LJ, Thomas CM, Ang A, Matthews AG, Hasson A, Annon J, Sparenborg S, Liu DS, McCormack J, Church S, Swafford W, Drexler K, Schuman C, Ross S, Wiest K, Korthuis PT, Lawson W, Brigham GS, Knox PC, Dawes M, Rotrosen J. Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: the Cocaine Use Reduction with Buprenorphine (CURB) study. Addiction. 2016 Aug;111(8):1416-27. doi: 10.1111/add.13375. Epub 2016 Apr 21.
Results Reference
result
PubMed Identifier
23159524
Citation
Mooney LJ, Nielsen S, Saxon A, Hillhouse M, Thomas C, Hasson A, Stablein D, McCormack J, Lindblad R, Ling W. Cocaine use reduction with buprenorphine (CURB): rationale, design, and methodology. Contemp Clin Trials. 2013 Mar;34(2):196-204. doi: 10.1016/j.cct.2012.11.002. Epub 2012 Nov 16.
Results Reference
derived
Links:
URL
http://www.drugabuse.gov/CTN/
Description
National Institute on Drug Abuse Clinical Trials Network Website
URL
http://ctndisseminationlibrary.org/
Description
Clinical Trials Network Dissemination Library Website
URL
http://www.uclaisap.org/
Description
UCLA Integrated Substance Abuse Programs Website

Learn more about this trial

Cocaine Use Reduction With Buprenorphine

We'll reach out to this number within 24 hrs