AzTrials
AzTrials

Cocaine DependencePhase 2/3CURBNCT01402492

Cocaine Use Reduction With Buprenorphine

A Phase 2/3 study testing Buprenorphine + Naltrexone in people with Cocaine Dependence, run by University of California, Los Angeles at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cocaine Dependence
What is being tested?
Buprenorphine + Naltrexone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
302 participants
Where
11 sitesUnited States
Study dates
Sep 2011to Mar 2013
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Atlanta VA Medical Center

    Atlanta, Georgia, 30345

  • Maryhaven

    Columbus, Ohio, 43207

  • Addiction Research and Treatment Services (ARTS)

    Denver, Colorado, 80206

  • UCLA Integrated Substance Abuse Programs (ISAP)

    Los Angeles, California, 90025

  • Bellevue Hospital Center

    New York, New York, 10016

  • CODA, Inc.

    Portland, Oregon, 97214

  • South Texas Veterans Health Care System

    San Antonio, Texas, 78229

  • Bay Area Addiction Research and Treatment (BAART)

    San Francisco, California, 94102

  • Recovery Centers of King County (RCKC)

    Seattle, Washington, 98122

  • Albert Einstein College of Medicine - Division of Substance Abuse

    The Bronx, New York, 10461

  • Howard University Hospital

    Washington D.C., District of Columbia, 20060

Other trials in United States

About this study

Official title: Cocaine Use Reduction With Buprenorphine (CURB)

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.

Read the 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.

Being tested
Buprenorphine + Naltrexone, Placebo + Naltrexone
Keywords
Cocaine-Related disorders, Cocaine, Substance-Related disorders, Opioid abuse, Opioid dependence, abuse, addiction, treatment, buprenorphine, naltrexone, Suboxone, Vivitrol
Medical subject headings
Cocaine-Related Disorders, Substance-Related Disorders, Opioid-Related Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Buprenorphine + NaltrexoneDrug

    Also called Suboxone, buprenorphine/naloxone, Vivitrol, extended release injectable 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.

  • Placebo + NaltrexoneDrug

    Also called Vivitrol, extended release injectable 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.

Study groups in NCT01402492
Study groupRoleWhat they receive
BUP4+XR-NTXExperimental4mg buprenorphine plus naltrexone for 8 weeks of treatment
Receives: Drug: Buprenorphine + Naltrexone
BUP16+XR-NTXExperimental16mg buprenorphine plus naltrexone for 8 weeks of treatment
Receives: Drug: Buprenorphine + Naltrexone
PLB+XR-NTXActive comparatornaltrexone for 8 weeks of treatment
Receives: Drug: Placebo + Naltrexone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: final 30 days of Treatment Phase, study days 25-54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionJan 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01402492
Sponsor's protocol ID
NIDA-CTN-0048
Other IDs
U10DA013045
Acronym
CURB
Status last verified
Jun 2021
First submitted
25 Jul 2011
Last updated
29 Oct 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26948856

  • Smith CL, Pelagio A, Schmidt A, McPherson S, Rodin N, Stark BC, Hosseini MA, Miguel AQC, Saxon AJ. Relationships between cannabis and cocaine use in a randomized trial of combined buprenorphine and naltrexone for DSM-IV cocaine dependence. Addict Behav. 2026 Jul 29;183:108817. doi: 10.1016/j.addbeh.2026.108817. Online ahead of print.

    PubMed 42561565

  • 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.

    PubMed 23159524

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Buprenorphine + Naltrexone in people with Cocaine Dependence, run by University of California, Los Angeles at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens (time frame: final 30 days of Treatment Phase, study days 25-54). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01402492, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in