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Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2) (CURB-2)

Primary Purpose

Cocaine Use Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Extended-Release Naltrexone
Extended Release Buprenorphine
Placebo (PLB) Injectable
Placebo (PLB) Injectable
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Use Disorder focused on measuring Naltrexone, Buprenorphine, Extended release injectable Naltrexone, Extended release injectable Buprenorphine, CUD, Cocaine, Cocaine Abuse

Eligibility Criteria

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

Inclusion Criteria:

Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study:

  1. Be 18 to 65 years of age;
  2. Be interested in reducing or stopping cocaine use;
  3. Meet DSM-5 criteria for moderate or severe CUD (4 or more criteria);
  4. Provide at least 2 urine samples positive for cocaine (out of a possible 3 samples) within a 10-day period collected over a maximum 21 days during screening with at least 2 days between visits;
  5. Self-report cocaine use on 18 or more days in the 30-day period prior to consent using the Timeline Follow-Back (TLFB);
  6. If female, agree to use acceptable birth control methods and have periodic urine pregnancy testing done during participation in the study unless unable to conceive (e.g., hysterectomy, post-menopause);
  7. Provide a urine sample negative for opioids and self-report no opioid use in the past 7 days on the TLFB and Prior and Concomitant Medications (PCM) assessment prior to XR-NTX induction;
  8. Be willing to comply with all study procedures and medication instructions.

Exclusion Criteria:

  1. Have a psychiatric condition that, in the judgement of the site medical clinician, would make study participation unsafe or which would prevent adherence to study procedures;

    Examples include:

    • Suicidal or homicidal ideation requiring immediate attention
    • Severe inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder);
  2. Have evidence of second- or third-degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening electrocardiogram (ECG) that, in the opinion of the site medical clinician, would preclude safe participation in the study;
  3. Have a medical condition that, in the judgement of the site medical clinician, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications or diluents and the following results on clinical labs assessed during baseline/screening:

    • AST or ALT greater than 5 times the upper limit of normal
    • Total bilirubin greater than 2 times the upper limit of normal
    • Platelet count <100 x 103/μL
  4. Have a body habitus that precludes gluteal intramuscular injection of XR-NTX or abdominal SQ injection of XR-BUP in accordance with the administration equipment (needle) and procedures;
  5. Have been in a prior study of pharmacological or behavioral treatment for CUD within 6 months of study consent;
  6. Have taken an investigational drug in another study within 30 days of study consent;
  7. Have been prescribed and taken naltrexone or buprenorphine within 30 days of study consent;
  8. Be currently enrolled in formal treatment studies or addiction treatment services (behavioral or pharmacological);
  9. Be at significant clinical risk for development of serotonin syndrome with buprenorphine treatment as determined by the site medical clinician;
  10. Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the site medical clinician;
  11. Have a surgery planned or scheduled or otherwise medically require the use of opioid-containing medications (e.g., opioid analgesics) during the study period;
  12. Be currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) in the judgement of the site investigator that could prevent participation in the study or in any study activities;
  13. If female, be currently pregnant, breastfeeding, or planning on conception;
  14. Have any condition for which, in the opinion of the site investigator or designee, study participation would not be in their best interest (including but not limited to cognitive impairment, unstable general medical condition, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • University of Arkansas for Medical SciencesRecruiting
  • UCLA Vine Street ClinicRecruiting
  • Center on Substance Use and Health (CSUH)Recruiting
  • Cove Behavioral HealthRecruiting
  • University of Illinois at ChicagoRecruiting
  • University of ChicagoRecruiting
  • Mountain Manor Treatment CenterRecruiting
  • Berman Center for Outcomes and Clinical Research at Hennepin HealthcareRecruiting
  • Addictions Institute of Mount SinaiRecruiting
  • UTSW Medical Center, Center for Depression Research and Clinical CareRecruiting
  • University of Texas Health San AntonioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug intervention (XR-NTX+XR-BUP)

Placebo

Arm Description

The study intervention is three doses of 380mg XR-NTX (Weeks 0, 3 and 6) and two doses of 300mg XR-BUP (Weeks 0, 4). Drug: XR-NTX XR-NTX: 3 intramuscular injections administered Week 0, 3, 6. Other Names: Extended Release Injectable Naltrexone Arm: Experimental Drug: XR-BUP XR-BUP: 2 subcutaneous injections administered Week 0, 4. Other Names: Extended Release Injectable Buprenorphine Arm: Experimental

Matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD). Drug: Placebo (PLB) Injectable Placebo: 3 intramuscular injections administered Week 0, 3, 6. Other Names: Injectable matching (to XR-NTX) placebo Arm: Placebo Comparator - matched Placebo (PLB) Drug: Placebo (PLB) Injectable Placebo: 2 subcutaneous injections administered Week 0, 4. Other Names: Injectable matching (to XR-BUP) placebo Arm: Placebo Comparator - matched Placebo (PLB)

Outcomes

Primary Outcome Measures

Proportion of Cocaine-negative UDS
The primary outcome measure is the proportion of cocaine-negative UDS obtained during Weeks 5 through 8 of the medication phase as measured for the XR-NTX + XR-BUP and PBO-Inj conditions. The primary outcome (UDS) has been chosen because it is an objective measure of cocaine use and was the outcome showing significant improvement over placebo in the original CURB trial.

Secondary Outcome Measures

Number of participants who Self-report cocaine use
Self-report elicited through Timeline Followback (TLFB) on days of cocaine use during Weeks 0-8;
Mean self reported cocaine craving score
Cocaine craving as measured by the Visual Analog Craving Scales (VAS) during Weeks 0-8. Possible scores range from 0 to 100, with higher scores indicating worse craving.
Measures of safety (adverse events)
Number and severity of adverse events reported during Weeks 0-8; Number and outcomes (non-fatal and fatal) of overdose events during Weeks 0-8
Mean self reported overall functioning
Self-report overall functioning as measured by the Treatment Effectiveness Assessment (TEA) at Week 8. Possible scores range from 1 to 10 for each of the 4 domains, with higher scores indicating better outcome.

Full Information

First Posted
February 17, 2022
Last Updated
October 3, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05262270
Brief Title
Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
Acronym
CURB-2
Official Title
Randomized, Placebo-Controlled Trial of Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an 8-week, double-blind, randomized placebo-controlled trial of the efficacy of a combination of extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP) compared to matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD).
Detailed Description
The primary objective of this study is to assess the efficacy of XR-NTX plus XR-BUP as a combination pharmacotherapy for CUD. Approximately four hundred and twenty-six adults will be randomized into the study at 8-12 sites in the U.S. Eligibility will be determined during a maximum 21-day screening period. To document current ongoing cocaine use, participants must submit at least 2 urine samples positive for cocaine of a possible 3 tests to occur within a 10-day period during which clinic visits occur with at least 2 days between visits. In addition, participants must meet diagnostic criteria for moderate or severe CUD per DSM-5 (4 or more criteria) at screening. After screening/baseline is completed and eligibility is confirmed, participants will be randomized and begin the 1-week medication induction phase followed by the 8-week medication phase of the trial. Participants will be randomized in a 1:1 ratio to either 1) XR-NTX + XR-BUP arm and receive injections of extended-release naltrexone (XR-NTX; as Vivitrol®) and extended-release buprenorphine (XR-BUP; as SublocadeTM), or to 2) PBO-Inj matching the timeline and delivery methods of injections for the XR-NTX + XR-BUP arm. XR-NTX or PBO-Inj injections will be provided on the day of randomization and in Weeks 3 and 6. XR-BUP or PBO-Inj injections will be provided on days 3-5 following randomization and in week 4. During the 1-week induction phase and the 8-week medication phase, participants will be asked to attend clinic twice weekly for collection of urine samples and to complete assessments as indicated on the schedule of assessments. Following the 8-week medication phase, participants will be asked to attend clinic weekly for the follow-up phase during Weeks 9-12. Participants will be involved in the study for approximately 16 weeks, including a screening/baseline period of up to 3 weeks (i.e., 21 days), 1 week for randomization and medication induction, 8 weeks of medication, and 4 weeks of follow-up. The screening phase may differ by participant in the length of time needed to complete preliminary eligibility assessments. Confirmation of opioid-free status (urine drug screen) will take place after confirmation of eligibility and before randomization. Randomization and medication induction visit may take approximately 2 hours. Twice-weekly visits during the medication phase will range from about 20 to 90 minutes in length depending on scheduled assessments. Medication administration visits may require an additional 2 hours. Visits in the follow-up phase will take place approximately 30-60 minutes to complete. An 8-week medication period was selected based on expected time for group differences to emerge and for pragmatic issues related to medication dosing. Enrollment is expected to take place over a period of approximately 13 months, with an approximate total of 16 months of study visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Use Disorder
Keywords
Naltrexone, Buprenorphine, Extended release injectable Naltrexone, Extended release injectable Buprenorphine, CUD, Cocaine, Cocaine Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The study intervention is three doses of 380mg XR-NTX (Weeks 0, 3 and 6) and two doses of 300mg XR-BUP (Weeks 0, 4). XR-NTX is delivered via intramuscular (IM) injection in the gluteus; XR-BUP is delivered via subcutaneous (SQ) injection in the abdomen.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is a double-blind, placebo-controlled study.
Allocation
Randomized
Enrollment
426 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug intervention (XR-NTX+XR-BUP)
Arm Type
Experimental
Arm Description
The study intervention is three doses of 380mg XR-NTX (Weeks 0, 3 and 6) and two doses of 300mg XR-BUP (Weeks 0, 4). Drug: XR-NTX XR-NTX: 3 intramuscular injections administered Week 0, 3, 6. Other Names: Extended Release Injectable Naltrexone Arm: Experimental Drug: XR-BUP XR-BUP: 2 subcutaneous injections administered Week 0, 4. Other Names: Extended Release Injectable Buprenorphine Arm: Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD). Drug: Placebo (PLB) Injectable Placebo: 3 intramuscular injections administered Week 0, 3, 6. Other Names: Injectable matching (to XR-NTX) placebo Arm: Placebo Comparator - matched Placebo (PLB) Drug: Placebo (PLB) Injectable Placebo: 2 subcutaneous injections administered Week 0, 4. Other Names: Injectable matching (to XR-BUP) placebo Arm: Placebo Comparator - matched Placebo (PLB)
Intervention Type
Drug
Intervention Name(s)
Extended-Release Naltrexone
Other Intervention Name(s)
XR-NTX
Intervention Description
XR-NTX (Extended-Release Naltrexone) doses of 380mg (Weeks 0, 3 and 6) via intramuscular (IM) injections in the gluteus.
Intervention Type
Drug
Intervention Name(s)
Extended Release Buprenorphine
Other Intervention Name(s)
XR-BUP
Intervention Description
Extended-Release buprenorphine (XR-BUP) two doses of 300mg XR-BUP (Weeks 0, 4) via subcutaneous injections in the abdomen. Option for 100mg at Weeks 3 and 6 (if needed to alleviate side effects).
Intervention Type
Drug
Intervention Name(s)
Placebo (PLB) Injectable
Other Intervention Name(s)
Injectable matching (to XR-NTX) placebo
Intervention Description
3 doses of intramuscular injections (Week 0, 3, 6)
Intervention Type
Drug
Intervention Name(s)
Placebo (PLB) Injectable
Other Intervention Name(s)
Injectable matching (to XR-BUP) placebo
Intervention Description
2 doses of subcutaneous injections (Week 0, 4)
Primary Outcome Measure Information:
Title
Proportion of Cocaine-negative UDS
Description
The primary outcome measure is the proportion of cocaine-negative UDS obtained during Weeks 5 through 8 of the medication phase as measured for the XR-NTX + XR-BUP and PBO-Inj conditions. The primary outcome (UDS) has been chosen because it is an objective measure of cocaine use and was the outcome showing significant improvement over placebo in the original CURB trial.
Time Frame
Week 5 up to Week 8
Secondary Outcome Measure Information:
Title
Number of participants who Self-report cocaine use
Description
Self-report elicited through Timeline Followback (TLFB) on days of cocaine use during Weeks 0-8;
Time Frame
8 Weeks
Title
Mean self reported cocaine craving score
Description
Cocaine craving as measured by the Visual Analog Craving Scales (VAS) during Weeks 0-8. Possible scores range from 0 to 100, with higher scores indicating worse craving.
Time Frame
8 Weeks
Title
Measures of safety (adverse events)
Description
Number and severity of adverse events reported during Weeks 0-8; Number and outcomes (non-fatal and fatal) of overdose events during Weeks 0-8
Time Frame
8 weeks
Title
Mean self reported overall functioning
Description
Self-report overall functioning as measured by the Treatment Effectiveness Assessment (TEA) at Week 8. Possible scores range from 1 to 10 for each of the 4 domains, with higher scores indicating better outcome.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Individuals must meet all of the inclusion criteria and no exclusion criteria in order to be eligible to participate in the study, including but not limited to: Inclusion Criteria: Be 18 to 65 years of age; Be interested in reducing or stopping cocaine use. Be willing to comply with all study procedures and medication instructions. Exclusion Criteria: 1. Have any condition for which, in the opinion of the site investigator or designee, study participation would not be in their best interest or that could prevent, limit, or confound the protocol-specified assessments.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madhukar H Trivedi, MD
Phone
214-648-0188
Email
CURB2@UTSouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Marino, PhD
Phone
214-648-0162
Email
CURB2@UTSouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhukar Trivedi, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melinda Clarke, MS
Phone
205-934-2832
Email
melindaclarke@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Shunte Fisher, MPH
Email
scarmich@uab.edu
First Name & Middle Initial & Last Name & Degree
Peter Hendricks, PhD
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Oliveto, PhD
Phone
501-526-8441
Email
olivetoalison@uams.edu
First Name & Middle Initial & Last Name & Degree
Alyssah Locklear, MS
Phone
501-526-8468
Email
alocklear@uams.edu
First Name & Middle Initial & Last Name & Degree
Alison Oliveto, PhD
Facility Name
UCLA Vine Street Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90038
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Tavarez
Phone
424-325-9632
Email
uclavsc@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Sandra R MacNicoll
Phone
323-461-3106
Email
uclavsc@mednet.uc.a.edu
First Name & Middle Initial & Last Name & Degree
Jesse Clark, MD, MSc
Facility Name
Center on Substance Use and Health (CSUH)
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Tan, MPH
Phone
628-217-6207
Email
judy.tan@sfdph.org
First Name & Middle Initial & Last Name & Degree
John Walker, RN, MSN
Phone
(628) 217-6227
Email
john.e.walker@sfdph.org
First Name & Middle Initial & Last Name & Degree
Phillip Coffin, MD, MIA
Facility Name
Cove Behavioral Health
City
Tampa
State/Province
Florida
ZIP/Postal Code
33605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Ramos, RN
Phone
813-277-4563
Email
janetr@covebh.org
First Name & Middle Initial & Last Name & Degree
Stephanie Samayoa, MPA
Phone
813-894-3609
Email
stephanies@covebh.org
First Name & Middle Initial & Last Name & Degree
Venkat Muvva, MD
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lily Caglianone, BS
Email
cagliano@uic.edu
First Name & Middle Initial & Last Name & Degree
Niranjan Karnik, MD, PhD
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madison Collins, BA
Phone
773-834-3778
Email
mcollins4@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Jon E Grant, JD, MD, MPH
Phone
773-834-1325
Email
jgrant4@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Jon E Grant, JD, MD, MPH
Facility Name
Mountain Manor Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Wenzel, PhD
Phone
410-233-1400
Email
kwenzel@marylandtreatment.org
First Name & Middle Initial & Last Name & Degree
Aline Rabalais, PhD
Phone
409-767-0843
Email
arabablais@marylandtreatment.org
First Name & Middle Initial & Last Name & Degree
Marc Fishman, MD
Facility Name
Berman Center for Outcomes and Clinical Research at Hennepin Healthcare
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Stevens
Phone
763-568-6969
Email
lstevens@bermancenter.org
First Name & Middle Initial & Last Name & Degree
Nate Tessum
Phone
612-873-6921
Email
ntessum@bermancenter.org
First Name & Middle Initial & Last Name & Degree
Gavin Bart, MD, PhD
Facility Name
Addictions Institute of Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashanta Carter, MSH
Phone
212-844-5717
Email
curb2study@mssm.edu
First Name & Middle Initial & Last Name & Degree
Samantha Huang, BS
Phone
212-585-4671
Email
curb2study@mssm.edu
First Name & Middle Initial & Last Name & Degree
Keren Bachi, PhD
Facility Name
UTSW Medical Center, Center for Depression Research and Clinical Care
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabella Huddleston
Phone
817-262-9157
Email
CURB2_109@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
McKenna Dougherty
Phone
469-602-2362
Email
CURB2_109@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Sidarth Wakhlu, MD
Facility Name
University of Texas Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanette Isabella Santos, BA
Phone
210-567-5438
Email
santosi@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Van King, MD
Phone
210-450-8058
Email
kingvl@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Van King, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from this study will be available to researchers on the website https://datashare.nida.nih.gov/ after the study is complete and the data is analyzed. This website will not include information that can identify individual study participants. The following information will be posted: Study protocol, reference to study publication of primary outcome, data sets (SAS and ASCII ), annotated case report forms, define file (also known as Data Dictionary), study-specific de-identification notes. Prior to downloading any study data, the user will be prompted to complete a registration agreement for data use. Users will have to register a name and valid e-mail address in order to download data and to accept their responsibility for using data in accordance with the NIDA Data Share Agreement.
Citations:
Citation
Center for Behavioral Health Statistics and Quality. 2019 National Survey on Drug Use and Health (NSDUH): CAI Specifications for Programming (English Version). Substance Abuse and Mental Health Services Administration, editor. Rockville, MD; 2018.
Results Reference
background
PubMed Identifier
27255266
Citation
Czoty PW, Stoops WW, Rush CR. Evaluation of the "Pipeline" for Development of Medications for Cocaine Use Disorder: A Review of Translational Preclinical, Human Laboratory, and Clinical Trial Research. Pharmacol Rev. 2016 Jul;68(3):533-62. doi: 10.1124/pr.115.011668.
Results Reference
background
PubMed Identifier
25762676
Citation
Whitfield TW Jr, Schlosburg JE, Wee S, Gould A, George O, Grant Y, Zamora-Martinez ER, Edwards S, Crawford E, Vendruscolo LF, Koob GF. kappa Opioid receptors in the nucleus accumbens shell mediate escalation of methamphetamine intake. J Neurosci. 2015 Mar 11;35(10):4296-305. doi: 10.1523/JNEUROSCI.1978-13.2015.
Results Reference
background
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
background
PubMed Identifier
21733477
Citation
Trivedi MH, Wisniewski SR, Morris DW, Fava M, Kurian BT, Gollan JK, Nierenberg AA, Warden D, Gaynes BN, Luther JF, Rush AJ. Concise Associated Symptoms Tracking scale: a brief self-report and clinician rating of symptoms associated with suicidality. J Clin Psychiatry. 2011 Jun;72(6):765-74. doi: 10.4088/JCP.11m06840.
Results Reference
background
PubMed Identifier
25194231
Citation
dela Cruz AM, Bernstein IH, Greer TL, Walker R, Rethorst CD, Grannemann B, Carmody T, Trivedi MH. Self-rated measure of pain frequency, intensity, and burden: psychometric properties of a new instrument for the assessment of pain. J Psychiatr Res. 2014 Dec;59:155-60. doi: 10.1016/j.jpsychires.2014.08.003. Epub 2014 Aug 27.
Results Reference
background
PubMed Identifier
23580868
Citation
Ling W, Farabee D, Liepa D, Wu LT. The Treatment Effectiveness Assessment (TEA): an efficient, patient-centered instrument for evaluating progress in recovery from addiction. Subst Abuse Rehabil. 2012 Jan 1;3(1):129-136. doi: 10.2147/SAR.S38902.
Results Reference
background
PubMed Identifier
17664051
Citation
Pettinati HM, Kampman KM, Lynch KG, Suh JJ, Dackis CA, Oslin DW, O'Brien CP. Gender differences with high-dose naltrexone in patients with co-occurring cocaine and alcohol dependence. J Subst Abuse Treat. 2008 Jun;34(4):378-90. doi: 10.1016/j.jsat.2007.05.011. Epub 2007 Jul 30.
Results Reference
background
PubMed Identifier
25603822
Citation
Nasser AF, Heidbreder C, Liu Y, Fudala PJ. Pharmacokinetics of Sublingual Buprenorphine and Naloxone in Subjects with Mild to Severe Hepatic Impairment (Child-Pugh Classes A, B, and C), in Hepatitis C Virus-Seropositive Subjects, and in Healthy Volunteers. Clin Pharmacokinet. 2015 Aug;54(8):837-49. doi: 10.1007/s40262-015-0238-6.
Results Reference
background
PubMed Identifier
24911028
Citation
Winhusen TM, Kropp F, Lindblad R, Douaihy A, Haynes L, Hodgkins C, Chartier K, Kampman KM, Sharma G, Lewis DF, VanVeldhuisen P, Theobald J, May J, Brigham GS. Multisite, randomized, double-blind, placebo-controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse-prevention treatment for cocaine dependence. J Clin Psychiatry. 2014 Jul;75(7):757-64. doi: 10.4088/JCP.13m08862.
Results Reference
background
PubMed Identifier
31048676
Citation
Kariisa M, Scholl L, Wilson N, Seth P, Hoots B. Drug Overdose Deaths Involving Cocaine and Psychostimulants with Abuse Potential - United States, 2003-2017. MMWR Morb Mortal Wkly Rep. 2019 May 3;68(17):388-395. doi: 10.15585/mmwr.mm6817a3.
Results Reference
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Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)

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