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Cocaine Use Reduction With Buprenorphine

Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Dependence

Intervention: Buprenorphine + Naltrexone (Drug); Placebo + Naltrexone (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Walter Ling

Official(s) and/or principal investigator(s):
Walter Ling, M.D., Principal Investigator, Affiliation: University of California, Los Angeles
Andrew J. Saxon, M.D., Principal Investigator, Affiliation: VA Puget Sound Health Care System
Larissa J. Mooney, M.D., Principal Investigator, Affiliation: University of California, Los Angeles

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.

Clinical Details

Official title: Cocaine Use Reduction With Buprenorphine (CURB)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Cocaine use days as measured by self-report, corroborated by thrice-weekly urine drug screens

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

UCLA Integrated Substance Abuse Programs (ISAP), Los Angeles, California 90025, United States

Bay Area Addiction Research and Treatment (BAART), San Francisco, California 94102, United States

Addiction Research and Treatment Services (ARTS), Denver, Colorado 80206, United States

Howard University Hospital, Washington, District of Columbia 20060, United States

Atlanta VA Medical Center, Atlanta, Georgia 30345, United States

Albert Einstein College of Medicine - Division of Substance Abuse, Bronx, New York 10461, United States

Bellevue Hospital Center, New York, New York 10016, United States

Maryhaven, Columbus, Ohio 43207, United States

CODA, Inc., Portland, Oregon 97214, United States

South Texas Veterans Health Care System, San Antonio, Texas 78229, United States

Recovery Centers of King County (RCKC), Seattle, Washington 98122, United States

Additional Information

National Institute on Drug Abuse Clinical Trials Network Website

Clinical Trials Network Dissemination Library Website

UCLA Integrated Substance Abuse Programs Website

Starting date: September 2011
Last updated: November 5, 2013

Page last updated: August 23, 2015

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