Cocaine Use Reduction With Buprenorphine (CURB)

This study has been completed.
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
Walter Ling, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01402492
First received: July 25, 2011
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Cocaine Dependence
Drug: Buprenorphine + Naltrexone
Drug: Placebo + Naltrexone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Cocaine Use Reduction With Buprenorphine (CURB)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Cocaine use days as measured by self-report, corroborated by thrice-weekly urine drug screens [ Time Frame: 30-day evaluation period ] [ Designated as safety issue: No ]
    30-day evaluation period is the final 30 days of active medication administration prior to taper; study days 25-54.


Enrollment: 302
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BUP4+XR-NTX
4mg buprenorphine plus naltrexone for 8 weeks of treatment
Drug: Buprenorphine + Naltrexone
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.
Other Names:
  • Suboxone
  • buprenorphine/naloxone
  • Vivitrol
  • extended release injectable naltrexone
Experimental: BUP16+XR-NTX
16mg buprenorphine plus naltrexone for 8 weeks of treatment
Drug: Buprenorphine + Naltrexone
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.
Other Names:
  • Suboxone
  • buprenorphine/naloxone
  • Vivitrol
  • extended release injectable naltrexone
Placebo Comparator: PLB+XR-NTX
Placebo plus naltrexone for 8 weeks of treatment
Drug: Placebo + Naltrexone
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.
Other Names:
  • Vivitrol
  • extended release injectable naltrexone

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 65 years of age
  • In good general health
  • Meet 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402492

Locations
United States, California
UCLA Integrated Substance Abuse Programs (ISAP)
Los Angeles, California, United States, 90025
Bay Area Addiction Research and Treatment (BAART)
San Francisco, California, United States, 94102
United States, Colorado
Addiction Research and Treatment Services (ARTS)
Denver, Colorado, United States, 80206
United States, District of Columbia
Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Georgia
Atlanta VA Medical Center
Atlanta, Georgia, United States, 30345
United States, New York
Albert Einstein College of Medicine - Division of Substance Abuse
Bronx, New York, United States, 10461
Bellevue Hospital Center
New York, New York, United States, 10016
United States, Ohio
Maryhaven
Columbus, Ohio, United States, 43207
United States, Oregon
CODA, Inc.
Portland, Oregon, United States, 97214
United States, Texas
South Texas Veterans Health Care System
San Antonio, Texas, United States, 78229
United States, Washington
Recovery Centers of King County (RCKC)
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Walter Ling
The EMMES Corporation
Investigators
Principal Investigator: Walter Ling, M.D. University of California, Los Angeles
Principal Investigator: Andrew J. Saxon, M.D. VA Puget Sound Health Care System
Principal Investigator: Larissa J. Mooney, M.D. University of California, Los Angeles
  More Information

Additional Information:
No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Walter Ling, Professor of Psychiatry and Director, UCLA Integrated Substance Abuse Programs, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01402492     History of Changes
Other Study ID Numbers: NIDA-CTN-0048, U10DA013045
Study First Received: July 25, 2011
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Cocaine-Related disorders
Cocaine
Substance-Related disorders
Opioid abuse
Opioid dependence
abuse
addiction
treatment
buprenorphine
naltrexone
Suboxone
Vivitrol

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Naltrexone
Naloxone
Cocaine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on July 29, 2014